thalidomide has been researched along with Local Neoplasm Recurrence in 295 studies
Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Bortezomib is active in heavily pretreated multiple myeloma patients; the dose-limiting toxicity is peripheral neuropathy (PN)." | 10.22 | Neurotoxicity of bortezomib therapy in multiple myeloma: a single-center experience and review of the literature. ( Akpek, G; Badros, A; Can, I; Dalal, JS; Fenton, RG; Goloubeva, O; Heyman, M; Rapoport, AP; Thompson, J, 2007) |
| "Elotuzumab plus pomalidomide/dexamethasone (E-Pd) demonstrated efficacy and safety in relapsed and refractory multiple myeloma (RRMM)." | 9.51 | Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. ( Ide, T; Osawa, M; Sanghavi, K; Vezina, HE, 2022) |
| "Patients with relapsed/refractory multiple myeloma (RRMM) need proven subsequent therapies after early-line lenalidomide treatment failure." | 9.51 | Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial. ( Acosta-Rivera, M; Agarwal, A; Anz, B; Bahlis, NJ; Bar, M; Berdeja, J; Chung, W; Fonseca, G; Ganguly, S; Lee, K; Matous, J; Mouro, J; Quick, D; Reece, D; Samaras, C; Schiller, GJ; Sebag, M; Seet, CS; Siegel, DS; Song, K, 2022) |
| " An exposure-response (E-R) analysis using data from patients with relapsed/refractory multiple myeloma (RRMM) enrolled in a phase Ib clinical study who received isatuximab at doses from 5 to 20 mg/kg weekly for 1 cycle (4 weeks) followed by every 2 weeks thereafter (qw/q2w) in combination with pomalidomide/dexamethasone (n = 44) was first used to determine the optimal dose/schedule for the phase III ICARIA-MM study." | 9.51 | Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma. ( Brillac, C; Fau, JB; Gaudel-Dedieu, N; Koiwai, K; Nguyen, L; Rachedi, F; Sebastien, B; Semiond, D; Thai, HT; van de Velde, H; Veyrat-Follet, C, 2022) |
| "In the first phase 3 study in relapsed/refractory AL amyloidosis (TOURMALINE-AL1 NCT01659658), 168 patients with relapsed/refractory AL amyloidosis after 1-2 prior lines were randomized to ixazomib (4 mg, days 1, 8, 15) plus dexamethasone (20 mg, days 1, 8, 15, 22; n = 85) or physician's choice (dexamethasone ± melphalan, cyclophosphamide, thalidomide, or lenalidomide; n = 83) in 28-day cycles until progression or toxicity." | 9.51 | A randomized phase 3 study of ixazomib-dexamethasone versus physician's choice in relapsed or refractory AL amyloidosis. ( Berg, D; Comenzo, RL; Dispenzieri, A; Faller, DV; Kastritis, E; Kim, K; Kumar, A; Kwok, F; Landau, HJ; Liu, G; Merlini, G; Sanchorawala, V; Schönland, SO; Suzuki, K; Wechalekar, AD, 2022) |
| "The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines." | 9.41 | Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. ( Assadourian, S; Campana, F; Dimopoulos, MA; Harrison, SJ; Leleu, X; Liberati, AM; Malinge, L; Miles Prince, H; Moreau, P; Ocio, EM; Richardson, PG; Sémiond, D; van de Velde, H; Yong, K, 2021) |
| "In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone (PVd) demonstrated superior efficacy vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma previously treated with lenalidomide, including those refractory to lenalidomide." | 9.41 | Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse. ( Anderson, LD; Biyukov, T; Casal, E; Corso, A; Dimopoulos, M; Dürig, J; Engelhardt, M; Jenner, M; Moreau, P; Nguyen, TV; Pavic, M; Peluso, T; Richardson, P; Salomo, M; San-Miguel, J; Sonneveld, P; Srinivasan, S; Weisel, K; White, D; Yu, X, 2021) |
| "In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response or better rate of 42% and was well tolerated in patients with heavily pretreated multiple myeloma." | 9.41 | Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. ( Ahmadi, T; Amin, H; Baldini, L; Beksac, M; Bila, J; Boccadoro, M; Carson, R; Delimpasi, S; Dimopoulos, MA; Einsele, H; Kampfenkel, T; Katodritou, E; Mateos, MV; Moreau, P; Orfanidis, I; Oriol, A; Qiu, Y; Schecter, JM; Sonneveld, P; Symeonidis, A; Terpos, E; Ukropec, J; Vermeulen, J, 2021) |
| "In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM)." | 9.34 | Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. ( Bahlis, NJ; Benboubker, L; Chiu, C; Cook, G; Dimopoulos, MA; Ho, PJ; Kaufman, JL; Kim, K; Krevvata, M; Leiba, M; Moreau, P; Okonkwo, L; Qi, M; Qin, X; San-Miguel, J; Takezako, N; Trivedi, S; Ukropec, J; White, DJ, 2020) |
| "In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib and dexamethasone (PVd) significantly improved the progression-free survival (PFS) and the overall response rate (ORR) vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma." | 9.34 | Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM. ( Biyukov, T; Matsue, K; Peluso, T; Richardson, P; Sakurai, S; Shinagawa, A; Sunami, K; Suzuki, K; Takezako, N; Tamakoshi, H, 2020) |
| "Patients with multiple myeloma who have relapsed after or become refractory to lenalidomide in early treatment lines represent a clinically important population in need of effective therapies." | 9.34 | Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment. ( Acosta-Rivera, M; Agarwal, A; Anz, B; Bahlis, NJ; Bar, M; Berdeja, J; Chung, W; Fonseca, G; Ganguly, S; Matous, J; Pierceall, WE; Quick, D; Reece, D; Samaras, C; Schiller, GJ; Sebag, M; Seet, CS; Siegel, DS; Song, K; Talamo, G; Zafar, F, 2020) |
| "Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma." | 9.30 | Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)-a trial by the Asian Myeloma Network. ( Asaoku, H; Chim, CS; Chng, WJ; Durie, B; Gopalakrishnan, SK; Huang, SY; Kim, JS; Kim, K; Kimura, H; Kosugi, H; Lee, JH; Lee, JJ; Lee, SL; Min, CK; Moorakonda, R; Nagarajan, C; Sakamoto, J; Soekojo, CY; Takezako, N; Wei, Y; Yoon, SS, 2019) |
| " In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone." | 9.30 | Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. ( Anderson, KC; Attal, M; Beksac, M; Campana, F; Cavo, M; Corzo, KP; Dimopoulos, MA; Dubin, F; Huang, JS; Le-Guennec, S; Leleu, X; Macé, S; Minarik, J; Moreau, P; Prince, HM; Rajkumar, SV; Richardson, PG; San-Miguel, J; Schjesvold, F; Spicka, I, 2019) |
| "The addition of clarithromycin enhances the efficacy of lenalidomide plus dexamethasone in treatment-naive multiple myeloma (MM)." | 9.30 | Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. ( Boyer, A; Coleman, M; Forsberg, PA; Jayabalan, D; Mark, TM; Niesvizky, R; Pearse, RN; Pekle, KA; Perry, A; Rossi, AC; Tegnestam, L, 2019) |
| "This phase 1b dose-escalation study evaluated isatuximab plus pomalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)." | 9.30 | A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. ( Anderson, K; Bensinger, W; Campana, F; Dubin, F; Kanagavel, D; Karanes, C; Liu, Q; Mikhael, J; Raje, N; Richardson, P; Semiond, D; Usmani, SZ, 2019) |
| "The combination of pomalidomide (POM) and dexamethasone (DEX) was evaluated for relapsed/refractory primary central nervous system lymphoma (PCNSL) and primary vitreoretinal lymphoma (PVRL) to determine the maximal tolerated dose (MTD) of POM as the primary objective, and overall response rate (ORR), progression-free survival (PFS), and safety profile as secondary objectives." | 9.27 | Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma. ( Atherton, PJ; DeAngelis, LM; Grommes, C; Jaeckle, KA; Johnston, PB; Koenig, PA; O'Neill, B; Omuro, AMP; Pederson, LD; Pulido, J; Reeder, CB; Schiff, D; Tun, HW; Witzig, TE, 2018) |
| "Carfilzomib, a proteasome inhibitor, is approved as monotherapy and in combination with dexamethasone or lenalidomide-dexamethasone (Rd) for relapsed or refractory multiple myeloma." | 9.24 | Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. ( Aggarwal, S; Dimopoulos, MA; Goranova-Marinova, V; Hájek, R; Jakubowiak, A; Ludwig, H; Masszi, T; Mihaylov, GG; Moreau, P; Niesvizky, R; Oriol, A; Palumbo, A; Rajnics, P; Ro, S; Rosiñol, L; San-Miguel, J; Siegel, D; Špička, I; Stewart, AK; Suvorov, A, 2017) |
| "This phase 1b, open-label, dose-escalation study assessed the safety, efficacy, and pharmacokinetics of anti-CD38 monoclonal antibody isatuximab given in 2 schedules (3, 5, or 10 mg/kg every other week [Q2W] or 10 or 20 mg/kg weekly [QW] for 4 weeks and then Q2W thereafter [QW/Q2W]), in combination with lenalidomide 25 mg (days 1-21) and dexamethasone 40 mg (QW), in patients with relapsed/refractory multiple myeloma (RRMM)." | 9.24 | A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. ( Baz, R; Benson, DM; Campana, F; Charpentier, E; Lendvai, N; Lesokhin, AM; Martin, T; Munster, P; Vij, R; Wack, C; Wolf, J, 2017) |
| "Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment." | 9.24 | Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. ( Ahmadi, T; Arnulf, B; Chari, A; Chiu, C; Comenzo, R; Fay, JW; Ifthikharuddin, JJ; Kaufman, JL; Khokhar, NZ; Krishnan, A; Lentzsch, S; Lonial, S; Nottage, K; Suvannasankha, A; Wang, J; Weiss, BM, 2017) |
| "The China Continuation study was a separate regional expansion of the global, double-blind, placebo-controlled, randomized phase III TOURMALINE-MM1 study of ixazomib plus lenalidomide-dexamethasone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM) following one to three prior therapies." | 9.24 | Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study. ( Chen, X; Du, X; Gupta, N; Hanley, MJ; Hou, J; Hua, Z; Jin, J; Ke, X; Li, H; Li, J; Liu, J; Lu, J; Moreau, P; Richardson, PG; van de Velde, H; Wang, B; Wang, H; Wu, D; Xu, Y; Zhang, X; Zhou, D, 2017) |
| "On November 19, 2015, a marketing authorization valid through the European Union was issued for carfilzomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy." | 9.24 | The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy. ( Bergh, J; Camarero Jiménez, J; Demolis, P; Garcia, I; Gisselbrecht, C; Laane, E; Ludwig, H; Martin, M; Moreau, A; Pignatti, F; Salmonson, T; Sancho-López, A; Tzogani, K, 2017) |
| " After discontinuation of lenalidomide, he had no arthritis relapse; it was then concluded that the patient had a lenalidomide-induced arthritis." | 9.22 | Lenalidomide-induced arthritis: A case report and review of literature and pharmacovigilance databases. ( Despas, F; Gauthier, M; Icard, C; Mocquot, P; Nogaro, JC, 2022) |
| "The efficacy and safety of lenalidomide plus low-dose dexamethasone (Rd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) was demonstrated in a phase 2, multicenter trial (MM-021)." | 9.22 | Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program. ( Cai, Z; Chen, F; DeMarco, D; Du, X; Hou, J; Jin, J; Ke, X; Li, X; Mei, J; Meng, F; Wu, D; Yu, L; Zhang, J; Zhou, DB, 2016) |
| "This single institution, open label Phase I-II dose escalation trial evaluated the safety and efficacy of the combination of lenalidomide (Revlimid®), cyclophosphamide and prednisone (CPR) in patients with relapsed/refractory multiple myeloma." | 9.20 | Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma. ( Anglin, P; Atenafu, EG; Chen, C; Jimenez-Zepeda, VH; Kukreti, V; Masih-Khan, E; Mikhael, JR; Reece, DE; Trudel, S, 2015) |
| "The combination of pomalidomide and low-dose dexamethasone (Pom-Dex) can be safely administered to patients with end-stage relapsed/refractory multiple myeloma (RRMM)." | 9.20 | Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. ( Arnulf, B; Attal, M; Avet-Loiseau, H; Banos, A; Benboubker, L; Brechiniac, S; Caillot, D; Decaux, O; Dib, M; Escoffre-Barbe, M; Facon, T; Fermand, JP; Fuzibet, JG; Garderet, L; Hulin, C; Karlin, L; Kolb, B; Lacotte, L; Legros, L; Leleu, X; Macro, M; Marit, G; Mathiot, C; Moreau, P; Onraed, B; Pegourie, B; Petillon, MO; Rodon, P; Roussel, M; Royer, B; Stoppa, AM; Thielemans, B; Tiab, M; Wetterwald, M, 2015) |
| "These findings suggest that lenalidomide in combination with antiinhibitory KIR therapy warrants further investigation in multiple myeloma as a steroid-sparing, dual immune therapy." | 9.20 | A Phase I Trial of the Anti-KIR Antibody IPH2101 and Lenalidomide in Patients with Relapsed/Refractory Multiple Myeloma. ( Andre, P; Benson, DM; Caligiuri, MA; Cohen, AD; Efebera, YA; Hofmeister, CC; Jagannath, S; Munshi, NC; Spitzer, G; Zerbib, R, 2015) |
| "This phase 1, open-label, dose-escalation study investigated the tolerated dose (recommended dose), safety, efficacy, and pharmacokinetics of pomalidomide alone or pomalidomide plus low-dose dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma." | 9.20 | Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. ( Chou, T; Doerr, T; Iida, S; Iwasaki, H; Kurihara, M; Matsue, K; Midorikawa, S; Ogawa, Y; Sunami, K; Tobinai, K; Zaki, M, 2015) |
| "This multicenter, open-label, randomized phase 2 study assessed the efficacy and safety of pomalidomide (POM) with/without low-dose dexamethasone (LoDEX) in patients with relapsed/refractory multiple myeloma (RRMM)." | 9.19 | Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. ( Anderson, KC; Bahlis, N; Baz, R; Belch, A; Chen, C; Chen, M; Hofmeister, CC; Jacques, C; Jagannath, S; Jakubowiak, A; Lacy, M; Lentzsch, S; Lonial, S; Matous, J; Mikhael, J; Raje, N; Richardson, PG; Shustik, C; Siegel, DS; Song, K; Vesole, D; Vij, R; Yu, Z; Zaki, MH, 2014) |
| "Carfilzomib, a selective proteasome inhibitor, has shown safety and efficacy in relapsed and/or refractory multiple myeloma." | 9.17 | Phase Ib dose-escalation study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. ( Alsina, M; Bensinger, WI; Kunkel, LA; Lee, S; Martin, TG; Niesvizky, R; Orlowski, RZ; Siegel, DS; Wang, M; Wong, AF, 2013) |
| "Pomalidomide plus low-dose dexamethasone, an oral regimen, could be considered a new treatment option in patients with refractory or relapsed and refractory multiple myeloma." | 9.17 | Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. ( Alegre, A; Banos, A; Belch, A; Cavo, M; Chen, C; Delforge, M; Dimopoulos, M; Garderet, L; Goldschmidt, H; Ivanova, V; Jacques, C; Karlin, L; Lacy, M; Martinez-Lopez, J; Miguel, JS; Moreau, P; Oriol, A; Palumbo, A; Schey, S; Song, K; Sonneveld, P; Sternas, L; Weisel, K; Yu, X; Zaki, M, 2013) |
| "We previously reported a phase 1b dose-escalation study of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) in relapsed or progressive multiple myeloma where the maximum planned dose (MPD) was carfilzomib 20 mg/m2 days 1 and 2 of cycle 1 and 27 mg/m2 days 8, 9, 15, 16, and thereafter; lenalidomide 25 mg days 1 to 21; and dexamethasone 40 mg once weekly on 28-day cycles." | 9.17 | Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. ( Alsina, M; Bensinger, W; Huang, M; Kavalerchik, E; Martin, T; Niesvizky, R; Orlowski, RZ; Siegel, DS; Wang, M, 2013) |
| "The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II study 9806 to determine the safety and efficacy of daily thalidomide with radiation therapy in patients with newly diagnosed glioblastoma." | 9.17 | A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806). ( Alexander, BM; Curran, WJ; Donahue, BA; Fine, HA; Hartford, AC; Kerlin, KJ; Mehta, MP; Richards, RS; Tremont, IW; Wang, M; Yung, WK, 2013) |
| "Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma." | 9.16 | Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. ( Avet-Loiseau, H; Baylon, HG; Bladé, J; Caravita, T; Facon, T; Glasmacher, A; Goranov, S; Hajek, R; Hillengass, J; Hulin, C; Kropff, M; Kueenburg, E; Liebisch, P; Lucy, L; Moehler, TM; Pattou, C; Robak, T; Zerbib, R, 2012) |
| "Our previous studies have shown that lowering the dose of pegylated liposomal doxorubicin (PLD) and bortezomib in combination with intravenous dexamethasone on a longer 4-week cycle maintained efficacy and improved tolerability in both previously untreated and relapsed/refractory (R/R) multiple myeloma (MM) patients." | 9.16 | A phase 2 study of pegylated liposomal doxorubicin, bortezomib, dexamethasone and lenalidomide for patients with relapsed/refractory multiple myeloma. ( Berenson, JR; Bravin, E; Cartmell, A; Chen, CS; Flam, M; Hilger, JD; Kazamel, T; Nassir, Y; Swift, RA; Vescio, R; Woliver, T; Yellin, O, 2012) |
| "In two randomized phase III trials (MM-009 and MM-010), lenalidomide plus dexamethasone significantly prolonged time to progression and overall survival (OS) in patients with relapsed/refractory multiple myeloma compared with dexamethasone alone." | 9.15 | Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. ( Bravo, ML; Dimopoulos, MA; Harousseau, JL; Knight, RD; Olesnyckyj, M; Rajkumar, SV; San-Miguel, JF; Siegel, D; Stadtmauer, EA; Weber, DM; Zeldis, JB, 2011) |
| "The treatment of patients with multiple myeloma usually includes many drugs including thalidomide, lenalidomide and bortezomib." | 9.15 | Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma. ( Adamczyk-Cioch, M; Dmoszynska, A; Grzasko, N; Helbig, G; Hus, M; Jawniak, D; Kozinska, J; Legiec, W; Morawska, M; Pluta, A; Szostek, M; Waciński, P; Woszczyk, D, 2011) |
| "Introduction of lenalidomide has expanded the therapeutic options for refractory and recurrent multiple myeloma (MM) patients." | 9.15 | Efficacy of dose-reduced lenalidomide in patients with refractory or recurrent multiple myeloma. ( Glasmacher, A; Gorschlüter, M; Schmidt-Wolf, IG; Schwamborn, K, 2011) |
| "Thalidomide and lenalidomide are immunomodulatory drugs (IMiDs) that produce high remission rates in the treatment of multiple myeloma." | 9.14 | Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma. ( Allred, JB; Bergsagel, PL; Buadi, F; Dingli, D; Dispenzieri, A; Fonseca, R; Gertz, MA; Greipp, PR; Hayman, SR; Kumar, S; Kyle, RA; Lacy, MQ; Laumann, K; Lust, JA; Mandrekar, SJ; Mikhael, JR; Rajkumar, SV; Roy, V; Russell, SJ; Stewart, AK, 2009) |
| "We conducted a phase 2 study with bortezomib, doxorubicin, and dexamethasone (PAD) followed by thalidomide and dexamethasone (TD) in patients with relapsed multiple myeloma (MM)." | 9.14 | Bortezomib, doxorubicin, and dexamethasone combination therapy followed by thalidomide and dexamethasone consolidation as a salvage treatment for relapsed or refractory multiple myeloma: analysis of efficacy and safety. ( Bang, SM; Chung, J; Do, YR; Jin, JY; Joo, YD; Kang, HJ; Kim, BS; Kim, HY; Kim, K; Lee, DS; Lee, GW; Lee, JH; Lee, JJ; Lee, MH; Lee, SS; Park, J; Ryoo, HM; Shim, H; Suh, C; Yoon, SS, 2010) |
| "This multicenter, open-label, non-comparative phase II trial evaluated the safety and efficacy of salvage therapy with lenalidomide, melphalan, prednisone and thalidomide (RMPT) in patients with relapsed/refractory multiple myeloma (MM)." | 9.14 | Lenalidomide, melphalan, prednisone and thalidomide (RMPT) for relapsed/refractory multiple myeloma. ( Boccadoro, M; Canepa, L; Crugnola, M; Falco, P; Falcone, AP; Federico, V; Genuardi, M; Larocca, A; Magarotto, V; Palumbo, A; Petrucci, MT; Sanpaolo, G, 2010) |
| "gov: NCT00507442) was conducted to determine the maximum tolerated dose (MTD) of cyclophosphamide in combination with bortezomib, dexamethasone and lenalidomide (VDCR) and to assess the safety and efficacy of this combination in untreated multiple myeloma patients." | 9.14 | Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study. ( Bhandari, M; Callander, N; Flinn, I; Gasparetto, C; Glass, J; Grosman, D; Hari, P; Krishnan, A; Kumar, SK; Noga, SJ; Rajkumar, SV; Richardson, PG; Rifkin, R; Sahovic, EA; Shi, H; Webb, IJ; Wolf, JL, 2010) |
| "To investigate the efficacy and toxicity of bortezomib based combination therapy for Chinese patients with relapsed or refractory multiple myeloma (MM), and to determine the combination regimen, dosage and cycles in application of bortezomib for MM therapy." | 9.13 | [Bortezomib-based combination therapy for relapsed or refractory multiple myeloma]. ( Chen, YB; Fu, WJ; Hou, J; Wang, DX; Xi, H; Yuan, ZG, 2008) |
| "Recently, the authors reported improved time to disease progression (TTP) with a combination of pegylated liposomal doxorubicin (PLD) and bortezomib compared with bortezomib alone in a phase 3 randomized trial in patients with recurrent/refractory multiple myeloma (MM)." | 9.13 | Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. ( Bladé, J; Hajek, R; Harousseau, JL; Nagler, A; Orlowski, RZ; Robak, T; Sonneveld, P; Spencer, A; Zhuang, SH, 2008) |
| "This phase II study aimed at determining the efficacy and safety of irinotecan combined with thalidomide in adults with recurrent glioblastoma multiforme (GBM) not taking enzyme-inducing anticonvulsants (EIACs)." | 9.13 | Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme. ( Colman, H; Conrad, CA; de Groot, JF; Giglio, P; Gilbert, MR; Groves, MD; Hess, KR; Hsu, SH; Ictech, SE; Jackson, EF; Levin, VA; Mahankali, S; Puduvalli, VK; Ritterhouse, MG; Yung, WK, 2008) |
| "We previously reported a pilot study of thalidomide monotherapy for Japanese patients with refractory or relapsed multiple myeloma." | 9.13 | Single-institute phase 2 study of thalidomide treatment for refractory or relapsed multiple myeloma: prognostic factors and unique toxicity profile. ( Hattori, Y; Ikeda, Y; Kakimoto, T; Morita, K; Okamoto, S; Shimada, N; Tanigawara, Y, 2008) |
| "To define the efficacy of thalidomide on the overall survival of patients with metastatic recurrent gynecologic sarcomas." | 9.12 | Phase II trial of thalidomide for advanced and recurrent gynecologic sarcoma: a brief communication from the New York Phase II consortium. ( Blank, SV; Christos, P; Fields, AL; Goldberg, GL; Murgo, A; Runowicz, CD; Timmins, P; Wadler, S; Yi-Shin Kuo, D, 2006) |
| "Laboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM)." | 9.12 | A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. ( Abrey, LE; Chang, SM; Cloughesy, TF; Conrad, CA; DeAngelis, LM; Gilbert, MR; Greenberg, H; Groves, MD; Hess, KR; Lamborn, KR; Liu, TJ; Peterson, P; Prados, MD; Puduvalli, VK; Schiff, D; Tremont-Lukats, IW; Wen, PY; Yung, WK, 2007) |
| "To evaluate the efficacy and adverse events (AEs) of thalidomide in previously treated, measurable, persistent or recurrent leiomyosarcoma (LMS) of the uterus, and to explore associations between angiogenic markers and treatment or clinical outcome." | 9.12 | A phase II trial of thalidomide in patients with refractory leiomyosarcoma of the uterus and correlation with biomarkers of angiogenesis: a gynecologic oncology group study. ( Benbrook, D; Darcy, KM; McMeekin, DS; Sill, MW; Stearns-Kurosawa, DJ; Waggoner, S; Webster, K, 2007) |
| " Thalidomide was well tolerated, with constipation and sedation being the major toxicities." | 9.09 | Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. ( Black, PM; Figg, WD; Fine, HA; Jaeckle, K; Kaplan, R; Kyritsis, AP; Levin, VA; Loeffler, JS; Pluda, JM; Wen, PY; Yung, WK, 2000) |
| "To assess response of recurrent malignant gliomas to thalidomide." | 9.09 | Thalidomide as an anti-angiogenic agent in relapsed gliomas. ( Brada, M; Dowe, A; Gore, M; Hines, F; Short, SC; Traish, D, 2001) |
| "The use of carfilzomib/pomalidomide single-agent or in combination with other agents in patients with refractory/relapsed multiple myeloma (RRMM) was not clearly clarified in clinical practice." | 8.95 | Carfilzomib/pomalidomide single-agent or in combination with other agents for the management of relapsed/refractory multiple myeloma: a meta-analysis of 37 trials. ( Fan, L; Hu, C; Ma, X; Ran, X; Yu, H; Zou, Y, 2017) |
| "On August 5, 2013, a marketing authorization valid throughout the European Union (EU) was issued for pomalidomide in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy." | 8.91 | The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use. ( Camarero, J; Flores, B; Gisselbrecht, C; Hanaizi, Z; Hemmings, R; Laane, E; Pignatti, F; Salmonson, T; Sancho-Lopez, A, 2015) |
| "Once characterized by a very poor outcome, multiple myeloma (MM) now has a significantly prolonged survival, with major improvements allowed by the use of 'novel agents': proteasome inhibitors (first-in-class bortezomib) and immunomodulatory compounds (IMiDs; first-in-class thalidomide and lenalidomide)." | 8.90 | Pomalidomide for multiple myeloma. ( Bories, C; Facon, T; Fouquet, G; Guidez, S; Herbaux, C; Javed, S; Leleu, X; Renaud, L, 2014) |
| "To define whether or not thalidomide exposure upfront to newly diagnosed patients with multiple myeloma would adversely impact postrelapse survival (PRS), we performed a meta-analysis of randomized controlled trials." | 8.88 | Postrelapse survival rate correlates with first-line treatment strategy with thalidomide in patients with newly diagnosed multiple myeloma: a meta-analysis. ( Cui, J; Liu, L; Sheng, Z; Wang, L, 2012) |
| "Lenalidomide and other new agents are improving survival of multiple myeloma patients." | 8.86 | Lenalidomide in multiple myeloma: current role and future directions. ( Bizzari, JP; Jacques, C; Knight, RD; Tozer, A; Zeldis, JB, 2010) |
| "Lenalidomide is a potent, novel thalidomide analog that has demonstrated promising clinical activity in patients with relapsed or refractory multiple myeloma (MM)." | 8.84 | Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. ( Tariman, JD, 2007) |
| "The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial." | 8.83 | A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myeloma. ( Glasmacher, A; Goldschmidt, H; Gorschlüter, M; Hahn, C; Hoffmann, F; Naumann, R; Orlopp, K; Schmidt-Wolf, I; von Lilienfeld-Toal, M, 2006) |
| "To detail the dyspnea encountered in women receiving thalidomide as therapy for advanced ovarian cancer." | 8.82 | Dyspnea during thalidomide treatment for advanced ovarian cancer. ( Dizon, DS; Gordinier, ME, 2005) |
| "In cohort C of the phase 2 MM-014 trial, the efficacy and safety of pomalidomide, dexamethasone, and daratumumab therapy were investigated in 18 Japanese patients with relapsed/refractory multiple myeloma (RRMM) after their most recent regimen of lenalidomide-based therapy (NCT01946477)." | 8.12 | Pomalidomide, dexamethasone, and daratumumab in Japanese patients with relapsed or refractory multiple myeloma after lenalidomide-based treatment. ( Chung, W; Iida, S; Iwasaki, H; Kuroda, J; Kuwayama, S; Lee, K; Matsue, K; Matsumoto, M; Nishio, M; Sugiura, I; Sunami, K, 2022) |
| "In the pivotal phase III, randomized, multicenter ICARIA-MM study (NCT02990338), isatuximab plus pomalidomide and dexamethasone (Isa-Pd) improved progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) in the overall population of patients with relapsed/refractory multiple myeloma." | 8.12 | Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. ( Campana, F; Huang, SY; Iida, S; Ikeda, T; Iyama, S; Kaneko, H; Kim, JS; Kim, K; Koh, Y; Lee, JH; Lin, TL; Matsumoto, M; Min, CK; Shimazaki, C; Sunami, K; Suzuki, K; Tada, K; Uchiyama, M; Wang, MC; Yeh, SP, 2022) |
| "The phase 3 APOLLO study demonstrated significantly better progression-free survival (PFS) and clinical responses with daratumumab, pomalidomide, and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM)." | 8.12 | Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. ( Bathija, S; Berringer, H; Dwarakanathan, HR; He, J; Heeg, B; Johnston, S; Kampfenkel, T; Lam, A; Mackay, E; Mendes, J; Ruan, H, 2022) |
| "For patients with multiple myeloma (MM) that relapsed after treatment with bortezomib- and lenalidomide-based regimens, there were no other treatment options in Korea until 2016." | 7.96 | Analysis of the Efficacy of Thalidomide Plus Dexamethasone-Based Regimens in Patients With Relapsed/Refractory Multiple Myeloma Who Received Prior Chemotherapy, Including Bortezomib and Lenalidomide: KMM-166 Study. ( Eom, HS; Jung, KS; Kim, HJ; Kim, JS; Kim, K; Kim, SH; Lee, JJ; Lee, JO; Min, CK; Shin, HJ, 2020) |
| "In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients." | 7.96 | Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma. ( Anttila, P; Basu, S; Ben-Yehuda, D; Biyukov, T; Byeff, P; Cascavilla, N; Dhanasiri, S; Dimopoulos, M; Grote, L; Guo, S; Hayden, PJ; Hus, M; Johnson, P; Kanate, AS; Krauth, MT; Larocca, A; Lucio, P; Mendeleeva, L; Moreau, P; Muelduer, E; Richardson, P; Rodríguez-Otero, P; Vural, F; Weisel, K; Yagci, M; Yu, X, 2020) |
| "Although there are several case reports of progressive multifocal leukoencephalopathy (PML) in multiple myeloma (MM), there are few reports of cases associated with pomalidomide." | 7.96 | Pomalidomide-associated progressive multifocal leukoencephalopathy in multiple myeloma: cortical susceptibility-weighted imaging hypointense findings prior to clinical deterioration. ( Ichinohe, T; Ishibashi, H; Kikumto, M; Maruyama, H; Nakamichi, K; Saijo, M; Takahashi, T; Takebayashi, Y; Ueno, H; Umemoto, K; Yasutomi, H, 2020) |
| "Addition of daratumumab to pomalidomide and low-dose dexamethasone (LoDEX) is a safe and effective combination for relapsed/refractory multiple myeloma treatment." | 7.96 | Immunomodulation in Pomalidomide, Dexamethasone, and Daratumumab-Treated Patients with Relapsed/Refractory Multiple Myeloma. ( Agarwal, A; Amatangelo, MD; Bahlis, NJ; Chung, W; Neri, P; Parekh, S; Pierceall, WE; Rahman, A; Serbina, N; Siegel, DS; Thakurta, A; Van Oekelen, O; Young, M, 2020) |
| "In conclusion, pomalidomide and dexamethasone has limited efficacy in patients with advanced MM and soft-tissue plasmacytomas." | 7.91 | Pomalidomide-dexamethasone for treatment of soft-tissue plasmacytomas in patients with relapsed / refractory multiple myeloma. ( Abella, E; Bladé, J; Cabezudo, E; Cibeira, MT; Clapés, V; Escoda, L; Fernández de Larrea, C; García-Guiñón, A; Gironella, M; Granell, M; Isola, I; Jiménez-Segura, R; López-Pardo, J; Oriol, A; Rosiñol, L; Soler, JA; Tovar, N, 2019) |
| "This phase Ib study evaluated oprozomib, an oral proteasome inhibitor, plus pomalidomide-dexamethasone in relapsed/refractory multiple myeloma (RRMM)." | 7.91 | Oprozomib, pomalidomide, and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma. ( Berdeja, JG; Berenson, JR; Chang, YL; Klippel, Z; Lyons, RM; Niesvizky, R; Rifkin, RM; Shah, J; Stadtmauer, EA; Usmani, S, 2019) |
| "We performed analyses of the randomized phase 3 ASPIRE and ENDEAVOR trials to investigate the efficacy of carfilzomib among subgroups of relapsed or refractory multiple myeloma patients who had early or late disease relapse following initiation of the immediately prior therapy." | 7.88 | Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. ( Blaedel, J; DeCosta, L; Goldschmidt, H; Leleu, X; Mateos, MV; Mikhael, J; Obreja, M; San-Miguel, J; Szabo, Z; Zhou, L, 2018) |
| "Lenalidomide in combination with dexamethasone (Len-dex) represents a highly effective treatment in relapsed/refractory multiple myeloma (RRMM) patients." | 7.85 | Secondary primary malignancies during the lenalidomide-dexamethasone regimen in relapsed/refractory multiple myeloma patients. ( Atenafu, EG; Chen, C; Chu, CM; Kotchetkov, R; Kukreti, V; Masih-Khan, E; Reece, DE; Tiedemann, R; Trudel, S, 2017) |
| "We analyzed the treatment responses, toxicities, and survival outcomes of patients with relapsed or refractory multiple myeloma who received daily thalidomide, cyclophosphamide, and dexamethasone (CTD) or daily thalidomide, melphalan, and prednisolone (MTP) at 17 medical centers in Korea." | 7.85 | Efficacy and toxicity of the combination chemotherapy of thalidomide, alkylating agent, and steroid for relapsed/refractory myeloma patients: a report from the Korean Multiple Myeloma Working Party (KMMWP) retrospective study. ( Choi, YS; Eom, HS; Han, JJ; Kang, HJ; Kim, HJ; Kim, K; Kim, MK; Kim, SH; Kwon, J; Lee, JH; Lee, JJ; Lee, JO; Lee, WS; Min, CK; Moon, JH; Yoon, DH; Yoon, SS, 2017) |
| "Here we discuss the case of a heavily pretreated male patient with relapsed-refractory multiple myeloma and previous monoclonal gammopathy of undetermined significance who initiated a fifth-line treatment with pomalidomide (4 mg orally, days 1-21 of a 28-day cycle) and low-dose dexamethasone (40 mg weekly orally)." | 7.85 | Pomalidomide experience: an effective therapeutic approach with immunomodulatory drugs in a patient with relapsed-refractory multiple myeloma. ( Ancora, F; Calafiore, V; Consoli, ML; Conticello, C; Di Raimondo, F; La Fauci, A; Parisi, M; Romano, A, 2017) |
| "We describe the case of a 54-year-old woman with relapse of multiple myeloma 3 years after myeloablative allogeneic stem cell transplant who developed abdominal pain and bloody diarrhea following 7 months of lenalidomide therapy." | 7.83 | Ischemic colitis diagnosed by magnetic resonance imaging during lenalidomide treatment in a patient with relapsed multiple myeloma. ( Bucalossi, A; Cioffi Squitieri, N; Guerrini, S; Mazzei, FG; Mazzei, MA; Volterrani, L, 2016) |
| "Neutropenia is a major dose-limiting toxicity associated with lenalidomide in relapsed/refractory multiple myeloma (MM)." | 7.81 | Intermittent granulocyte colony-stimulating factor for neutropenia management in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone. ( Atenafu, EG; Chen, C; Kukreti, V; Masih-Khan, E; Reece, DE; Sun, HL; Trudel, S; Winter, A; Yeboah, E, 2015) |
| "Clinical studies evaluating the efffectiveness of pomalidomide based regimens on response and safety for patients with refractory and relapsed multiple myeloma were identified using a predefined search strategy." | 7.81 | Pooled analysis of pomalidomide for treating patients with multiple myeloma. ( Sun, JJ; Yang, HL; Zhang, C; Zhou, J, 2015) |
| "To explore the clinical efficacies and toxicities of lenalidomide combination chemotherapy in the treatment of relapsing or refractory multiple myeloma (MM) patients." | 7.81 | [Clinical observations of lenalidomide combination chemotherapy for relapsing or refractory multiple myeloma]. ( An, N; Chen, S; Hu, Y; Huang, Z; Li, X; Shen, M; Sun, W; Zhan, X; Zhang, J; Zhong, Y, 2015) |
| "The novel agents bortezomib and lenalidomide improve outcomes in multiple myeloma, yet most patients will relapse after exhausting treatment." | 7.79 | Pomalidomide in the treatment of relapsed multiple myeloma. ( Forsberg, PA; Mark, TM, 2013) |
| "Lenalidomide in combination with dexamethasone (Len/Dex) is indicated for patients with recurrent/refractory multiple myeloma (RRMM) who were treated with 1 prior therapy until evidence of disease progression." | 7.79 | Efficacy and safety profile of long-term exposure to lenalidomide in patients with recurrent multiple myeloma. ( Avet Loiseau, H; Bonnet, S; Debarri, H; Demarquette, H; Facon, T; Fouquet, G; Gay, J; Guidez, S; Herbaux, C; Hulin, C; Leleu, X; Michel, J; Miljkovic, D; Perrot, A; Serrier, C; Tardy, S, 2013) |
| "An expert panel convened to reach a consensus regarding the optimal use of lenalidomide in combination with dexamethasone (Len/Dex) in patients with relapsed or refractory multiple myeloma (RRMM)." | 7.77 | Optimizing the use of lenalidomide in relapsed or refractory multiple myeloma: consensus statement. ( Attal, M; Beksaç, M; da Costa, FL; Davies, FE; Delforge, M; Dimopoulos, MA; Einsele, H; Hajek, R; Harousseau, JL; Ludwig, H; Mellqvist, UH; Morgan, GJ; Palumbo, A; San-Miguel, JF; Sonneveld, P; Zweegman, S, 2011) |
| "A total of 106 relapsed or refractory multiple myeloma patients received lenalidomide 25mg plus dexamethasone as salvage therapy; 80 patients progressed on thalidomide treatment (thalidomide-resistant) and 26 patients discontinued thalidomide in at least partial remission (thalidomide-sensitive)." | 7.77 | Previous thalidomide therapy may not affect lenalidomide response and outcome in relapse or refractory multiple myeloma patients. ( Benevolo, G; Berruti, A; Boccadoro, M; Bringhen, S; Caravita, T; Cavallo, F; Corradini, P; Gay, F; Guglielmelli, T; Montefusco, V; Offidani, M; Palumbo, A; Petrucci, MT; Piro, E; Rrodhe, S; Saglio, G, 2011) |
| "There was no association between functional CYP2C19 and CYP2D6 alleles and treatment outcome in multiple myeloma patients treated with cyclophosphamide, thalidomide or bortezomib." | 7.76 | No influence of the polymorphisms CYP2C19 and CYP2D6 on the efficacy of cyclophosphamide, thalidomide, and bortezomib in patients with Multiple Myeloma. ( Abildgaard, N; Andersen, NF; Gimsing, P; Gregersen, H; Klausen, TW; Rasmussen, HB; Søeby, K; Vangsted, AJ; Vogel, U; Werge, T, 2010) |
| " Thalidomide is an immunomodulatory drug with numerous properties that has proven effective in relapsed multiple myeloma and, to a lesser extent, in other hematologic diseases." | 7.73 | Single-agent thalidomide induces response in T-cell lymphoma. ( Bilger, K; Bouabdallah, R; Damaj, G; Gastaut, JA; Mohty, M; Vey, N, 2005) |
| "Remarkable results of the treatment of refractory multiple myeloma with thalidomide have been reported." | 7.72 | Low dose thalidomide in patients with relapsed or refractory multiple myeloma. ( Ackermann, J; Dimou, G; Drach, J; Gisslinger, H; Kees, M; Lechner, K; Sillaber, C, 2003) |
| "The aim of this study was to assess the prognostic value of pretreatment clinical and laboratory parameters in refractory or relapsed multiple myeloma (MM) patients who have a long-term response to thalidomide (THAL), lasting at least 18 months." | 7.72 | An evaluation of factors predicting long-term response to thalidomide in 234 patients with relapsed or resistant multiple myeloma. ( Ciepluch, H; Dmoszynska, A; Hellmann, A; Hus, I; Hus, M; Jawniak, D; Kloczko, J; Konopka, L; Manko, J; Robak, T; Skotnicki, A; Soroka-Wojtaszko, M; Sulek, K; Wolska-Smolen, T, 2004) |
| " The purpose of our study was to compare postcontrast T1-weighted imaging with dynamic, contrast-enhanced T2*-weighted echo-planar imaging in the evaluation of the response of recurrent malignant gliomas to thalidomide and carboplatin." | 7.70 | Dynamic contrast-enhanced T2-weighted MR imaging of recurrent malignant gliomas treated with thalidomide and carboplatin. ( Cha, S; Glass, J; Gruber, ML; Johnson, G; Knopp, EA; Litt, A; Lu, S; Zagzag, D, 2000) |
| " The novel quadruplet combination was overall well-tolerated, with clinically manageable adverse events." | 7.11 | A phase 2 trial of the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high-risk relapsed/refractory multiple myeloma. ( Berenson, JR; Eades, B; Eshaghian, S; Ghermezi, M; Lim, S; Martinez, D; Schwartz, G; Spektor, TM; Swift, RA; Vescio, R; Yashar, D, 2022) |
| "Treatment for relapsed/refractory multiple myeloma (RRMM) remains an unmet need." | 6.87 | Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA Phase III study design. ( Anderson, KC; Attal, M; Campana, F; Corzo, K; Hui, AM; Le-Guennec, S; Richardson, PG; Risse, ML, 2018) |
| "Lenalidomide is a suitable candidate for long-lasting maintenance as it is an oral drug, active against DLBCL that can be taken for years with an acceptable toxicity profile." | 6.84 | Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. ( Arcari, A; Bertoldero, G; Calimeri, T; Cecchetti, C; Chiozzotto, M; Couto, S; Fabbri, A; Ferreri, AJ; Frezzato, M; Govi, S; Nonis, A; Ponzoni, M; Re, A; Ren, Y; Rocco, AD; Rusconi, C; Sassone, M; Scarfò, L; Spina, M; Stelitano, C; Zaja, F; Zambello, R, 2017) |
| "Lenalidomide 10 mg/d was identified as the MTD because, in the 15 mg cohort, one patient experienced dose-limiting toxicity (grade 3 angioedema) and two patients had mobilization failure." | 6.82 | Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group. ( Caballero, D; Canales, M; Dlouhy, I; González-Barca, E; López-Guillermo, A; Martín, A; Montes-Moreno, S; Ocio, EM; Redondo, AM; Salar, A, 2016) |
| "We conducted a phase I dose escalation study to determine the maximal tolerated dose of bortezomib that could be combined with standard dose lenalidomide in patients with MDS or AML." | 6.78 | Phase I dose escalation study of bortezomib in combination with lenalidomide in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). ( Amrein, PC; Attar, EC; Ballen, KK; Deangelo, DJ; Fathi, AT; Foster, J; Fraser, JW; McAfee, S; Neuberg, D; Steensma, DP; Stone, RM; Wadleigh, M, 2013) |
| "The lenalidomide dose was 25 mg/day, and was adjusted according to baseline renal function." | 6.78 | A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial. ( Ai, H; Cai, Z; Chen, F; Chen, N; Du, X; Hou, J; Jin, J; Ke, X; Li, X; Mei, J; Meng, F; Wang, J; Wortman-Vayn, H; Wu, D; Yu, L; Zhang, J; Zhou, DB, 2013) |
| "Thalidomide was well tolerated: the most common side effects were constipation (76." | 6.71 | Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004) |
| "Thalidomide has recently been recognized as an effective new agent for previously untreated, refractory or relapsed myeloma." | 6.71 | Low-dose thalidomide for multiple myeloma: interim analysis of a compassionate use program. ( Gastl, G; Mitterer, M; Spizzo, G; Steurer, M, 2004) |
| "Thalidomide was given orally at a daily dose of 200 mg/day, which was then escalated every 2 weeks by 200 mg/day as tolerated to a maximum of 800 mg/day." | 6.71 | Phase II study of thalidomide in patients with metastatic malignant melanoma. ( Cancela, AI; Costa, TD; Di Leone, LP; Fernandes, S; Reiriz, AB; Richter, MF; Schwartsmann, G, 2004) |
| "Thalidomide is a well-tolerated drug that may have some activity in the treatment of recurrent glioblastoma." | 6.70 | Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme. ( Bell, DR; Biggs, M; Boyle, FM; Cook, R; Levi, JA; Little, N; Marx, GM; McCowatt, S; Pavlakis, N; Wheeler, HR, 2001) |
| " The treatment outcomes of MAbs versus HDACi in combination with bortezomib or lenalidomide plus dexamethasone remain unknown." | 6.58 | Monoclonal Antibodies versus Histone Deacetylase Inhibitors in Combination with Bortezomib or Lenalidomide plus Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma: An Indirect-Comparison Meta-Analysis of Randomized Controlled Trial ( Chen, X; Feng, J; Gao, G; Shen, H; Tang, H; Xu, L; Zhang, N; Zheng, Y, 2018) |
| "Pomalidomide is a potent second-generation immunomodulatory agent with direct antiproliferative, pro-apoptotic, and antiangiogenic effects, as well as modulatory effects on bone resorption and on the immune system." | 6.50 | [Pomalidomide in the treatment of relapsed and refractory multiple myeloma]. ( Bátorová, A; Mistrík, M; Roziaková, L, 2014) |
| "For many years the treatment of multiple myeloma was limited to such regimens as melphalan-prednisone, high-dose dexamethasone, and vincristine-doxorubicin-dexamethasone (VAD)." | 6.44 | Lenalidomide in multiple myeloma. ( Richards, TA; Thomas, SK; Weber, DM, 2007) |
| "Cure for multiple myeloma is rare; the success of treatment is measured by response, and length of remissions and survival." | 6.43 | Management of multiple myeloma with bortezomib: experts review the data and debate the issues. ( Boccadoro, M; Cavenagh, J; Dicato, M; Harousseau, JL; Ludwig, H; San Miguel, J; Sonneveld, P, 2006) |
| "Bortezomib is active in heavily pretreated multiple myeloma patients; the dose-limiting toxicity is peripheral neuropathy (PN)." | 6.22 | Neurotoxicity of bortezomib therapy in multiple myeloma: a single-center experience and review of the literature. ( Akpek, G; Badros, A; Can, I; Dalal, JS; Fenton, RG; Goloubeva, O; Heyman, M; Rapoport, AP; Thompson, J, 2007) |
| "Lenalidomide is an important medication used in induction therapy for MM and is also used for maintenance therapy for standard risk patients." | 5.72 | Three Cases of Lenalidomide Therapy for Multiple Myeloma and Subsequent Development of Secondary B-ALL. ( Asawa, P; Chahine, Z; Lister, J; Sadashiv, S; Samhouri, Y; Vusqa, UT, 2022) |
| "The treatment of multiple myeloma has dramatically improved due to the availability of novel therapies that are highly effective and are quickly moving into first-line therapy." | 5.72 | Sequential Use of Carfilzomib and Pomalidomide in Relapsed Multiple Myeloma: A Report from the Canadian Myeloma Research Group (CMRG) Database. ( Aslam, M; Gul, E; Jimenez-Zepeda, VH; Kardjadj, M; Kotb, R; LeBlanc, R; Louzada, M; Masih-Khan, E; McCurdy, A; Mian, H; Reece, D; Reiman, A; Sebag, M; Song, K; Stakiw, J; Venner, CP; White, D, 2022) |
| "Pomalidomide was given at 4 mg orally on days 1 to 21 of a 28-day cycle, and dexamethasone at 20 or 40 mg weekly." | 5.62 | Outcomes of Daratumumab, Pomalidomide, and Dexamethasone, Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation, in Patients With Relapsed/Refractory Multiple Myeloma. ( Abdallah, AO; Atrash, S; Ganguly, S; Kawsar, H; Mahmoudjafari, Z; McGuirk, J; Mohyuddin, GR; Shune, L; Sigle, M, 2021) |
| "Multiple myeloma is an incurable progressive neoplastic disease that accounts for 10% of all hematologic malignancies." | 5.56 | Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel Combination Treatment of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone. ( Kassir, N; Li, Y; Palmisano, M; Wang, X; Zhou, S, 2020) |
| "Thalidomide is a medication with strong anti-inflammatory, immunomodulatory, antiangiogenic, and sedative properties." | 5.56 | Thalidomide as a potential adjuvant treatment for paraneoplastic pemphigus: A single-center experience. ( Pan, M; Wang, J; Zhang, Y, 2020) |
| "Elotuzumab plus pomalidomide/dexamethasone (E-Pd) demonstrated efficacy and safety in relapsed and refractory multiple myeloma (RRMM)." | 5.51 | Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. ( Ide, T; Osawa, M; Sanghavi, K; Vezina, HE, 2022) |
| "Patients with relapsed/refractory multiple myeloma (RRMM) need proven subsequent therapies after early-line lenalidomide treatment failure." | 5.51 | Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial. ( Acosta-Rivera, M; Agarwal, A; Anz, B; Bahlis, NJ; Bar, M; Berdeja, J; Chung, W; Fonseca, G; Ganguly, S; Lee, K; Matous, J; Mouro, J; Quick, D; Reece, D; Samaras, C; Schiller, GJ; Sebag, M; Seet, CS; Siegel, DS; Song, K, 2022) |
| " An exposure-response (E-R) analysis using data from patients with relapsed/refractory multiple myeloma (RRMM) enrolled in a phase Ib clinical study who received isatuximab at doses from 5 to 20 mg/kg weekly for 1 cycle (4 weeks) followed by every 2 weeks thereafter (qw/q2w) in combination with pomalidomide/dexamethasone (n = 44) was first used to determine the optimal dose/schedule for the phase III ICARIA-MM study." | 5.51 | Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma. ( Brillac, C; Fau, JB; Gaudel-Dedieu, N; Koiwai, K; Nguyen, L; Rachedi, F; Sebastien, B; Semiond, D; Thai, HT; van de Velde, H; Veyrat-Follet, C, 2022) |
| "In the first phase 3 study in relapsed/refractory AL amyloidosis (TOURMALINE-AL1 NCT01659658), 168 patients with relapsed/refractory AL amyloidosis after 1-2 prior lines were randomized to ixazomib (4 mg, days 1, 8, 15) plus dexamethasone (20 mg, days 1, 8, 15, 22; n = 85) or physician's choice (dexamethasone ± melphalan, cyclophosphamide, thalidomide, or lenalidomide; n = 83) in 28-day cycles until progression or toxicity." | 5.51 | A randomized phase 3 study of ixazomib-dexamethasone versus physician's choice in relapsed or refractory AL amyloidosis. ( Berg, D; Comenzo, RL; Dispenzieri, A; Faller, DV; Kastritis, E; Kim, K; Kumar, A; Kwok, F; Landau, HJ; Liu, G; Merlini, G; Sanchorawala, V; Schönland, SO; Suzuki, K; Wechalekar, AD, 2022) |
| "An 85-year-old female was diagnosed with multiple myeloma(MM)(IgG-l)with t(4 ;14)(p16;q32)in 200X." | 5.48 | [Successful Treatment with Pomalidomide, Bortezomib, and Dexamethasone in a Patient with Frail Refractory and Relapsed Multiple Myeloma with Extramedullary Disease]. ( Nougawa, M; Oka, S; Shimazu, Y; Shiragami, H; Takeuchi, S, 2018) |
| "Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs)." | 5.46 | Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. ( Anttila, P; Bahlis, N; Biyukov, T; Cavo, M; Chen, C; Cook, G; Corradini, P; Delforge, M; Dimopoulos, MA; Hansson, M; Herring, J; Hong, K; Joao, C; Kaiser, M; Moreau, P; O'Gorman, P; Oriol, A; Raymakers, R; Richardson, PG; San-Miguel, J; Siegel, DS; Slaughter, A; Song, K; Sternas, L; Weisel, K; Yu, X; Zaki, M, 2017) |
| " LenDex was interrupted in three cases because of adverse events (infections and cutaneous events); 78 % of the patients were on thromboprophylaxis with aspirin." | 5.43 | Lenalidomide is effective and safe for the treatment of patients with relapsed multiple myeloma and very severe renal impairment. ( Coelho, I; Esteves, GV; Esteves, S; Freitas, J; Geraldes, C; Gomes, F; João, C; Lúcio, P; Neves, M, 2016) |
| "Lenalidomide at 25 mg was superior to 15 mg in terms of response (complete remission 21% and partial remission 23% vs." | 5.43 | Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Is It a Valid Treatment Option? ( Cuzzocrea, S; Ferrero, S; Ghione, P; Marabese, A; Mian, M; Mondello, P; Pitini, V; Steiner, N; Willenbacher, W, 2016) |
| "In the Phase III ICARIA-MM study (NCT02990338), the addition of the anti-CD38 monoclonal antibody isatuximab to pomalidomide and dexamethasone led to increased progression-free survival and improved response rates in patients with relapsed/refractory multiple myeloma." | 5.41 | Isatuximab for relapsed/refractory multiple myeloma: review of key subgroup analyses from the Phase III ICARIA-MM study. ( Bringhen, S; Campana, F; Dimopoulos, MA; Harrison, SJ; Le-Guennec, S; Macé, S; Richardson, PG; Schjesvold, F; Yong, K, 2021) |
| "The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines." | 5.41 | Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. ( Assadourian, S; Campana, F; Dimopoulos, MA; Harrison, SJ; Leleu, X; Liberati, AM; Malinge, L; Miles Prince, H; Moreau, P; Ocio, EM; Richardson, PG; Sémiond, D; van de Velde, H; Yong, K, 2021) |
| "In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone (PVd) demonstrated superior efficacy vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma previously treated with lenalidomide, including those refractory to lenalidomide." | 5.41 | Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse. ( Anderson, LD; Biyukov, T; Casal, E; Corso, A; Dimopoulos, M; Dürig, J; Engelhardt, M; Jenner, M; Moreau, P; Nguyen, TV; Pavic, M; Peluso, T; Richardson, P; Salomo, M; San-Miguel, J; Sonneveld, P; Srinivasan, S; Weisel, K; White, D; Yu, X, 2021) |
| "gov number, NCT02283775) evaluated safety and efficacy of a fixed-volume infusion of isatuximab, an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma patients." | 5.41 | Final results of a phase 1b study of isatuximab short-duration fixed-volume infusion combination therapy for relapsed/refractory multiple myeloma. ( Bensinger, WI; Bianchi, G; Campana, F; D'Souza, A; Dubin, F; Kanagavel, D; Karanes, C; Laubach, JP; Raje, N; Richardson, PG; Saleem, R; Sborov, D; Tuchman, SA; Usmani, SZ, 2021) |
| "In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response or better rate of 42% and was well tolerated in patients with heavily pretreated multiple myeloma." | 5.41 | Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. ( Ahmadi, T; Amin, H; Baldini, L; Beksac, M; Bila, J; Boccadoro, M; Carson, R; Delimpasi, S; Dimopoulos, MA; Einsele, H; Kampfenkel, T; Katodritou, E; Mateos, MV; Moreau, P; Orfanidis, I; Oriol, A; Qiu, Y; Schecter, JM; Sonneveld, P; Symeonidis, A; Terpos, E; Ukropec, J; Vermeulen, J, 2021) |
| "Neutropenia was the main side effect of the metronomic therapy." | 5.38 | Treatment for recurrent medulloblastoma with intrathecal liposomal cytarabine and systemic metronomic combination therapy. ( Kivivuori, SM; Nygaard, R, 2012) |
| "Recurrence of multiple myeloma (MM) after therapy suggests the presence of tumor-initiating subpopulations." | 5.37 | Lenalidomide targets clonogenic side population in multiple myeloma: pathophysiologic and clinical implications. ( Adamia, S; Anderson, KC; Blotta, S; Cervi, D; Cholujova, D; Daley, JF; Delmore, J; Jakubikova, J; Klippel, S; Kong, SY; Kost-Alimova, M; Laubach, J; Leiba, M; Mitsiades, CS; Ooi, M; Richardson, PG; Sedlak, J, 2011) |
| "The impact of cumulative dosing and premature drug discontinuation (PMDD) of bortezomib (V), thalidomide (T), and dexamethasone (D) on overall survival (OS), event-free survival (EFS), time to next therapy, and post-relapse survival in Total Therapy 3 were examined, using time-dependent methodology, relevant to induction, peritransplantation, consolidation, and maintenance phases." | 5.36 | Total Therapy 3 for multiple myeloma: prognostic implications of cumulative dosing and premature discontinuation of VTD maintenance components, bortezomib, thalidomide, and dexamethasone, relevant to all phases of therapy. ( Alsayed, Y; Anaissie, E; Barlogie, B; Crowley, J; Hoering, A; Nair, B; Petty, N; Shaughnessy, JD; Szymonifka, J; van Rhee, F; Waheed, S, 2010) |
| "In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM)." | 5.34 | Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. ( Bahlis, NJ; Benboubker, L; Chiu, C; Cook, G; Dimopoulos, MA; Ho, PJ; Kaufman, JL; Kim, K; Krevvata, M; Leiba, M; Moreau, P; Okonkwo, L; Qi, M; Qin, X; San-Miguel, J; Takezako, N; Trivedi, S; Ukropec, J; White, DJ, 2020) |
| "In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib and dexamethasone (PVd) significantly improved the progression-free survival (PFS) and the overall response rate (ORR) vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma." | 5.34 | Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM. ( Biyukov, T; Matsue, K; Peluso, T; Richardson, P; Sakurai, S; Shinagawa, A; Sunami, K; Suzuki, K; Takezako, N; Tamakoshi, H, 2020) |
| "Patients with multiple myeloma who have relapsed after or become refractory to lenalidomide in early treatment lines represent a clinically important population in need of effective therapies." | 5.34 | Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment. ( Acosta-Rivera, M; Agarwal, A; Anz, B; Bahlis, NJ; Bar, M; Berdeja, J; Chung, W; Fonseca, G; Ganguly, S; Matous, J; Pierceall, WE; Quick, D; Reece, D; Samaras, C; Schiller, GJ; Sebag, M; Seet, CS; Siegel, DS; Song, K; Talamo, G; Zafar, F, 2020) |
| "Thalidomide has recently shown antitumor activity in patients with refractory myeloma." | 5.31 | Thalidomide in refractory and relapsing multiple myeloma. ( Bladé, J; Esteve, J; Montoto, S; Montserrat, E; Perales, M; Rosiñol, L; Tuset, M, 2001) |
| "Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma." | 5.30 | Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)-a trial by the Asian Myeloma Network. ( Asaoku, H; Chim, CS; Chng, WJ; Durie, B; Gopalakrishnan, SK; Huang, SY; Kim, JS; Kim, K; Kimura, H; Kosugi, H; Lee, JH; Lee, JJ; Lee, SL; Min, CK; Moorakonda, R; Nagarajan, C; Sakamoto, J; Soekojo, CY; Takezako, N; Wei, Y; Yoon, SS, 2019) |
| " In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone." | 5.30 | Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. ( Anderson, KC; Attal, M; Beksac, M; Campana, F; Cavo, M; Corzo, KP; Dimopoulos, MA; Dubin, F; Huang, JS; Le-Guennec, S; Leleu, X; Macé, S; Minarik, J; Moreau, P; Prince, HM; Rajkumar, SV; Richardson, PG; San-Miguel, J; Schjesvold, F; Spicka, I, 2019) |
| "The addition of clarithromycin enhances the efficacy of lenalidomide plus dexamethasone in treatment-naive multiple myeloma (MM)." | 5.30 | Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. ( Boyer, A; Coleman, M; Forsberg, PA; Jayabalan, D; Mark, TM; Niesvizky, R; Pearse, RN; Pekle, KA; Perry, A; Rossi, AC; Tegnestam, L, 2019) |
| "This phase 1b dose-escalation study evaluated isatuximab plus pomalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)." | 5.30 | A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. ( Anderson, K; Bensinger, W; Campana, F; Dubin, F; Kanagavel, D; Karanes, C; Liu, Q; Mikhael, J; Raje, N; Richardson, P; Semiond, D; Usmani, SZ, 2019) |
| "The combination of pomalidomide (POM) and dexamethasone (DEX) was evaluated for relapsed/refractory primary central nervous system lymphoma (PCNSL) and primary vitreoretinal lymphoma (PVRL) to determine the maximal tolerated dose (MTD) of POM as the primary objective, and overall response rate (ORR), progression-free survival (PFS), and safety profile as secondary objectives." | 5.27 | Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma. ( Atherton, PJ; DeAngelis, LM; Grommes, C; Jaeckle, KA; Johnston, PB; Koenig, PA; O'Neill, B; Omuro, AMP; Pederson, LD; Pulido, J; Reeder, CB; Schiff, D; Tun, HW; Witzig, TE, 2018) |
| "Carfilzomib, a proteasome inhibitor, is approved as monotherapy and in combination with dexamethasone or lenalidomide-dexamethasone (Rd) for relapsed or refractory multiple myeloma." | 5.24 | Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. ( Aggarwal, S; Dimopoulos, MA; Goranova-Marinova, V; Hájek, R; Jakubowiak, A; Ludwig, H; Masszi, T; Mihaylov, GG; Moreau, P; Niesvizky, R; Oriol, A; Palumbo, A; Rajnics, P; Ro, S; Rosiñol, L; San-Miguel, J; Siegel, D; Špička, I; Stewart, AK; Suvorov, A, 2017) |
| "This phase 1b, open-label, dose-escalation study assessed the safety, efficacy, and pharmacokinetics of anti-CD38 monoclonal antibody isatuximab given in 2 schedules (3, 5, or 10 mg/kg every other week [Q2W] or 10 or 20 mg/kg weekly [QW] for 4 weeks and then Q2W thereafter [QW/Q2W]), in combination with lenalidomide 25 mg (days 1-21) and dexamethasone 40 mg (QW), in patients with relapsed/refractory multiple myeloma (RRMM)." | 5.24 | A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. ( Baz, R; Benson, DM; Campana, F; Charpentier, E; Lendvai, N; Lesokhin, AM; Martin, T; Munster, P; Vij, R; Wack, C; Wolf, J, 2017) |
| "Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment." | 5.24 | Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. ( Ahmadi, T; Arnulf, B; Chari, A; Chiu, C; Comenzo, R; Fay, JW; Ifthikharuddin, JJ; Kaufman, JL; Khokhar, NZ; Krishnan, A; Lentzsch, S; Lonial, S; Nottage, K; Suvannasankha, A; Wang, J; Weiss, BM, 2017) |
| "The China Continuation study was a separate regional expansion of the global, double-blind, placebo-controlled, randomized phase III TOURMALINE-MM1 study of ixazomib plus lenalidomide-dexamethasone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM) following one to three prior therapies." | 5.24 | Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study. ( Chen, X; Du, X; Gupta, N; Hanley, MJ; Hou, J; Hua, Z; Jin, J; Ke, X; Li, H; Li, J; Liu, J; Lu, J; Moreau, P; Richardson, PG; van de Velde, H; Wang, B; Wang, H; Wu, D; Xu, Y; Zhang, X; Zhou, D, 2017) |
| "On November 19, 2015, a marketing authorization valid through the European Union was issued for carfilzomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy." | 5.24 | The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy. ( Bergh, J; Camarero Jiménez, J; Demolis, P; Garcia, I; Gisselbrecht, C; Laane, E; Ludwig, H; Martin, M; Moreau, A; Pignatti, F; Salmonson, T; Sancho-López, A; Tzogani, K, 2017) |
| " After discontinuation of lenalidomide, he had no arthritis relapse; it was then concluded that the patient had a lenalidomide-induced arthritis." | 5.22 | Lenalidomide-induced arthritis: A case report and review of literature and pharmacovigilance databases. ( Despas, F; Gauthier, M; Icard, C; Mocquot, P; Nogaro, JC, 2022) |
| "The efficacy and safety of lenalidomide plus low-dose dexamethasone (Rd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) was demonstrated in a phase 2, multicenter trial (MM-021)." | 5.22 | Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program. ( Cai, Z; Chen, F; DeMarco, D; Du, X; Hou, J; Jin, J; Ke, X; Li, X; Mei, J; Meng, F; Wu, D; Yu, L; Zhang, J; Zhou, DB, 2016) |
| "This single institution, open label Phase I-II dose escalation trial evaluated the safety and efficacy of the combination of lenalidomide (Revlimid®), cyclophosphamide and prednisone (CPR) in patients with relapsed/refractory multiple myeloma." | 5.20 | Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma. ( Anglin, P; Atenafu, EG; Chen, C; Jimenez-Zepeda, VH; Kukreti, V; Masih-Khan, E; Mikhael, JR; Reece, DE; Trudel, S, 2015) |
| "The combination of pomalidomide and low-dose dexamethasone (Pom-Dex) can be safely administered to patients with end-stage relapsed/refractory multiple myeloma (RRMM)." | 5.20 | Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. ( Arnulf, B; Attal, M; Avet-Loiseau, H; Banos, A; Benboubker, L; Brechiniac, S; Caillot, D; Decaux, O; Dib, M; Escoffre-Barbe, M; Facon, T; Fermand, JP; Fuzibet, JG; Garderet, L; Hulin, C; Karlin, L; Kolb, B; Lacotte, L; Legros, L; Leleu, X; Macro, M; Marit, G; Mathiot, C; Moreau, P; Onraed, B; Pegourie, B; Petillon, MO; Rodon, P; Roussel, M; Royer, B; Stoppa, AM; Thielemans, B; Tiab, M; Wetterwald, M, 2015) |
| "These findings suggest that lenalidomide in combination with antiinhibitory KIR therapy warrants further investigation in multiple myeloma as a steroid-sparing, dual immune therapy." | 5.20 | A Phase I Trial of the Anti-KIR Antibody IPH2101 and Lenalidomide in Patients with Relapsed/Refractory Multiple Myeloma. ( Andre, P; Benson, DM; Caligiuri, MA; Cohen, AD; Efebera, YA; Hofmeister, CC; Jagannath, S; Munshi, NC; Spitzer, G; Zerbib, R, 2015) |
| "This phase 1, open-label, dose-escalation study investigated the tolerated dose (recommended dose), safety, efficacy, and pharmacokinetics of pomalidomide alone or pomalidomide plus low-dose dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma." | 5.20 | Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. ( Chou, T; Doerr, T; Iida, S; Iwasaki, H; Kurihara, M; Matsue, K; Midorikawa, S; Ogawa, Y; Sunami, K; Tobinai, K; Zaki, M, 2015) |
| " Aspirin or heparin was recommended for patients at high thrombosis risk." | 5.20 | Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance). ( Bartlett, NL; Blum, KA; Cheson, BD; Czuczman, M; Giguere, JK; Johnson, J; Jung, SH; Leonard, JP; Pitcher, BN, 2015) |
| "This multicenter, open-label, randomized phase 2 study assessed the efficacy and safety of pomalidomide (POM) with/without low-dose dexamethasone (LoDEX) in patients with relapsed/refractory multiple myeloma (RRMM)." | 5.19 | Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. ( Anderson, KC; Bahlis, N; Baz, R; Belch, A; Chen, C; Chen, M; Hofmeister, CC; Jacques, C; Jagannath, S; Jakubowiak, A; Lacy, M; Lentzsch, S; Lonial, S; Matous, J; Mikhael, J; Raje, N; Richardson, PG; Shustik, C; Siegel, DS; Song, K; Vesole, D; Vij, R; Yu, Z; Zaki, MH, 2014) |
| "Carfilzomib, a selective proteasome inhibitor, has shown safety and efficacy in relapsed and/or refractory multiple myeloma." | 5.17 | Phase Ib dose-escalation study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. ( Alsina, M; Bensinger, WI; Kunkel, LA; Lee, S; Martin, TG; Niesvizky, R; Orlowski, RZ; Siegel, DS; Wang, M; Wong, AF, 2013) |
| "Pomalidomide plus low-dose dexamethasone, an oral regimen, could be considered a new treatment option in patients with refractory or relapsed and refractory multiple myeloma." | 5.17 | Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. ( Alegre, A; Banos, A; Belch, A; Cavo, M; Chen, C; Delforge, M; Dimopoulos, M; Garderet, L; Goldschmidt, H; Ivanova, V; Jacques, C; Karlin, L; Lacy, M; Martinez-Lopez, J; Miguel, JS; Moreau, P; Oriol, A; Palumbo, A; Schey, S; Song, K; Sonneveld, P; Sternas, L; Weisel, K; Yu, X; Zaki, M, 2013) |
| "We previously reported a phase 1b dose-escalation study of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) in relapsed or progressive multiple myeloma where the maximum planned dose (MPD) was carfilzomib 20 mg/m2 days 1 and 2 of cycle 1 and 27 mg/m2 days 8, 9, 15, 16, and thereafter; lenalidomide 25 mg days 1 to 21; and dexamethasone 40 mg once weekly on 28-day cycles." | 5.17 | Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. ( Alsina, M; Bensinger, W; Huang, M; Kavalerchik, E; Martin, T; Niesvizky, R; Orlowski, RZ; Siegel, DS; Wang, M, 2013) |
| "The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II study 9806 to determine the safety and efficacy of daily thalidomide with radiation therapy in patients with newly diagnosed glioblastoma." | 5.17 | A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806). ( Alexander, BM; Curran, WJ; Donahue, BA; Fine, HA; Hartford, AC; Kerlin, KJ; Mehta, MP; Richards, RS; Tremont, IW; Wang, M; Yung, WK, 2013) |
| "Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma." | 5.16 | Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. ( Avet-Loiseau, H; Baylon, HG; Bladé, J; Caravita, T; Facon, T; Glasmacher, A; Goranov, S; Hajek, R; Hillengass, J; Hulin, C; Kropff, M; Kueenburg, E; Liebisch, P; Lucy, L; Moehler, TM; Pattou, C; Robak, T; Zerbib, R, 2012) |
| "Our previous studies have shown that lowering the dose of pegylated liposomal doxorubicin (PLD) and bortezomib in combination with intravenous dexamethasone on a longer 4-week cycle maintained efficacy and improved tolerability in both previously untreated and relapsed/refractory (R/R) multiple myeloma (MM) patients." | 5.16 | A phase 2 study of pegylated liposomal doxorubicin, bortezomib, dexamethasone and lenalidomide for patients with relapsed/refractory multiple myeloma. ( Berenson, JR; Bravin, E; Cartmell, A; Chen, CS; Flam, M; Hilger, JD; Kazamel, T; Nassir, Y; Swift, RA; Vescio, R; Woliver, T; Yellin, O, 2012) |
| "In two randomized phase III trials (MM-009 and MM-010), lenalidomide plus dexamethasone significantly prolonged time to progression and overall survival (OS) in patients with relapsed/refractory multiple myeloma compared with dexamethasone alone." | 5.15 | Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. ( Bravo, ML; Dimopoulos, MA; Harousseau, JL; Knight, RD; Olesnyckyj, M; Rajkumar, SV; San-Miguel, JF; Siegel, D; Stadtmauer, EA; Weber, DM; Zeldis, JB, 2011) |
| "The treatment of patients with multiple myeloma usually includes many drugs including thalidomide, lenalidomide and bortezomib." | 5.15 | Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma. ( Adamczyk-Cioch, M; Dmoszynska, A; Grzasko, N; Helbig, G; Hus, M; Jawniak, D; Kozinska, J; Legiec, W; Morawska, M; Pluta, A; Szostek, M; Waciński, P; Woszczyk, D, 2011) |
| "Introduction of lenalidomide has expanded the therapeutic options for refractory and recurrent multiple myeloma (MM) patients." | 5.15 | Efficacy of dose-reduced lenalidomide in patients with refractory or recurrent multiple myeloma. ( Glasmacher, A; Gorschlüter, M; Schmidt-Wolf, IG; Schwamborn, K, 2011) |
| "Thalidomide and lenalidomide are immunomodulatory drugs (IMiDs) that produce high remission rates in the treatment of multiple myeloma." | 5.14 | Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma. ( Allred, JB; Bergsagel, PL; Buadi, F; Dingli, D; Dispenzieri, A; Fonseca, R; Gertz, MA; Greipp, PR; Hayman, SR; Kumar, S; Kyle, RA; Lacy, MQ; Laumann, K; Lust, JA; Mandrekar, SJ; Mikhael, JR; Rajkumar, SV; Roy, V; Russell, SJ; Stewart, AK, 2009) |
| "We conducted a phase 2 study with bortezomib, doxorubicin, and dexamethasone (PAD) followed by thalidomide and dexamethasone (TD) in patients with relapsed multiple myeloma (MM)." | 5.14 | Bortezomib, doxorubicin, and dexamethasone combination therapy followed by thalidomide and dexamethasone consolidation as a salvage treatment for relapsed or refractory multiple myeloma: analysis of efficacy and safety. ( Bang, SM; Chung, J; Do, YR; Jin, JY; Joo, YD; Kang, HJ; Kim, BS; Kim, HY; Kim, K; Lee, DS; Lee, GW; Lee, JH; Lee, JJ; Lee, MH; Lee, SS; Park, J; Ryoo, HM; Shim, H; Suh, C; Yoon, SS, 2010) |
| "This multicenter, open-label, non-comparative phase II trial evaluated the safety and efficacy of salvage therapy with lenalidomide, melphalan, prednisone and thalidomide (RMPT) in patients with relapsed/refractory multiple myeloma (MM)." | 5.14 | Lenalidomide, melphalan, prednisone and thalidomide (RMPT) for relapsed/refractory multiple myeloma. ( Boccadoro, M; Canepa, L; Crugnola, M; Falco, P; Falcone, AP; Federico, V; Genuardi, M; Larocca, A; Magarotto, V; Palumbo, A; Petrucci, MT; Sanpaolo, G, 2010) |
| "gov: NCT00507442) was conducted to determine the maximum tolerated dose (MTD) of cyclophosphamide in combination with bortezomib, dexamethasone and lenalidomide (VDCR) and to assess the safety and efficacy of this combination in untreated multiple myeloma patients." | 5.14 | Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study. ( Bhandari, M; Callander, N; Flinn, I; Gasparetto, C; Glass, J; Grosman, D; Hari, P; Krishnan, A; Kumar, SK; Noga, SJ; Rajkumar, SV; Richardson, PG; Rifkin, R; Sahovic, EA; Shi, H; Webb, IJ; Wolf, JL, 2010) |
| "To investigate the efficacy and toxicity of bortezomib based combination therapy for Chinese patients with relapsed or refractory multiple myeloma (MM), and to determine the combination regimen, dosage and cycles in application of bortezomib for MM therapy." | 5.13 | [Bortezomib-based combination therapy for relapsed or refractory multiple myeloma]. ( Chen, YB; Fu, WJ; Hou, J; Wang, DX; Xi, H; Yuan, ZG, 2008) |
| "Recently, the authors reported improved time to disease progression (TTP) with a combination of pegylated liposomal doxorubicin (PLD) and bortezomib compared with bortezomib alone in a phase 3 randomized trial in patients with recurrent/refractory multiple myeloma (MM)." | 5.13 | Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. ( Bladé, J; Hajek, R; Harousseau, JL; Nagler, A; Orlowski, RZ; Robak, T; Sonneveld, P; Spencer, A; Zhuang, SH, 2008) |
| "This phase II study aimed at determining the efficacy and safety of irinotecan combined with thalidomide in adults with recurrent glioblastoma multiforme (GBM) not taking enzyme-inducing anticonvulsants (EIACs)." | 5.13 | Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme. ( Colman, H; Conrad, CA; de Groot, JF; Giglio, P; Gilbert, MR; Groves, MD; Hess, KR; Hsu, SH; Ictech, SE; Jackson, EF; Levin, VA; Mahankali, S; Puduvalli, VK; Ritterhouse, MG; Yung, WK, 2008) |
| "We previously reported a pilot study of thalidomide monotherapy for Japanese patients with refractory or relapsed multiple myeloma." | 5.13 | Single-institute phase 2 study of thalidomide treatment for refractory or relapsed multiple myeloma: prognostic factors and unique toxicity profile. ( Hattori, Y; Ikeda, Y; Kakimoto, T; Morita, K; Okamoto, S; Shimada, N; Tanigawara, Y, 2008) |
| "To define the efficacy of thalidomide on the overall survival of patients with metastatic recurrent gynecologic sarcomas." | 5.12 | Phase II trial of thalidomide for advanced and recurrent gynecologic sarcoma: a brief communication from the New York Phase II consortium. ( Blank, SV; Christos, P; Fields, AL; Goldberg, GL; Murgo, A; Runowicz, CD; Timmins, P; Wadler, S; Yi-Shin Kuo, D, 2006) |
| "Laboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM)." | 5.12 | A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. ( Abrey, LE; Chang, SM; Cloughesy, TF; Conrad, CA; DeAngelis, LM; Gilbert, MR; Greenberg, H; Groves, MD; Hess, KR; Lamborn, KR; Liu, TJ; Peterson, P; Prados, MD; Puduvalli, VK; Schiff, D; Tremont-Lukats, IW; Wen, PY; Yung, WK, 2007) |
| "To evaluate the efficacy and adverse events (AEs) of thalidomide in previously treated, measurable, persistent or recurrent leiomyosarcoma (LMS) of the uterus, and to explore associations between angiogenic markers and treatment or clinical outcome." | 5.12 | A phase II trial of thalidomide in patients with refractory leiomyosarcoma of the uterus and correlation with biomarkers of angiogenesis: a gynecologic oncology group study. ( Benbrook, D; Darcy, KM; McMeekin, DS; Sill, MW; Stearns-Kurosawa, DJ; Waggoner, S; Webster, K, 2007) |
| " Thalidomide was well tolerated, with constipation and sedation being the major toxicities." | 5.09 | Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. ( Black, PM; Figg, WD; Fine, HA; Jaeckle, K; Kaplan, R; Kyritsis, AP; Levin, VA; Loeffler, JS; Pluda, JM; Wen, PY; Yung, WK, 2000) |
| "To assess response of recurrent malignant gliomas to thalidomide." | 5.09 | Thalidomide as an anti-angiogenic agent in relapsed gliomas. ( Brada, M; Dowe, A; Gore, M; Hines, F; Short, SC; Traish, D, 2001) |
| "The use of carfilzomib/pomalidomide single-agent or in combination with other agents in patients with refractory/relapsed multiple myeloma (RRMM) was not clearly clarified in clinical practice." | 4.95 | Carfilzomib/pomalidomide single-agent or in combination with other agents for the management of relapsed/refractory multiple myeloma: a meta-analysis of 37 trials. ( Fan, L; Hu, C; Ma, X; Ran, X; Yu, H; Zou, Y, 2017) |
| "Despite significant improvement in outcomes have been observed for multiple myeloma (MM) patients over the past 10-15 years, mainly due to the introduction of novel agents targeting the tumor clone and the bone marrow microenvironment, treatment of refractory and/or relapsed (RR) disease remains a challenge, particularly for patients who have failed prior bortezomib- and lenalidomide-based therapies." | 4.93 | Current and emerging triplet combination therapies for relapsed and refractory multiple myeloma. ( Brioli, A; Cavo, M; Mancuso, K; Martello, M; Pantani, L; Rizzello, I; Rocchi, S; Tacchetti, P; Terragna, C; Zamagni, E; Zannetti, BA, 2016) |
| "Elotuzumab, a first-in-class immunostimulatory monoclonal antibody, is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1-3 prior therapies." | 4.93 | Update on elotuzumab, a novel anti-SLAMF7 monoclonal antibody for the treatment of multiple myeloma. ( Kaufman, J; Laubach, J; Lonial, S; Mateos, MV; Reece, D; Richardson, P, 2016) |
| "On August 5, 2013, a marketing authorization valid throughout the European Union (EU) was issued for pomalidomide in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy." | 4.91 | The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use. ( Camarero, J; Flores, B; Gisselbrecht, C; Hanaizi, Z; Hemmings, R; Laane, E; Pignatti, F; Salmonson, T; Sancho-Lopez, A, 2015) |
| "Once characterized by a very poor outcome, multiple myeloma (MM) now has a significantly prolonged survival, with major improvements allowed by the use of 'novel agents': proteasome inhibitors (first-in-class bortezomib) and immunomodulatory compounds (IMiDs; first-in-class thalidomide and lenalidomide)." | 4.90 | Pomalidomide for multiple myeloma. ( Bories, C; Facon, T; Fouquet, G; Guidez, S; Herbaux, C; Javed, S; Leleu, X; Renaud, L, 2014) |
| "To define whether or not thalidomide exposure upfront to newly diagnosed patients with multiple myeloma would adversely impact postrelapse survival (PRS), we performed a meta-analysis of randomized controlled trials." | 4.88 | Postrelapse survival rate correlates with first-line treatment strategy with thalidomide in patients with newly diagnosed multiple myeloma: a meta-analysis. ( Cui, J; Liu, L; Sheng, Z; Wang, L, 2012) |
| "Lenalidomide and other new agents are improving survival of multiple myeloma patients." | 4.86 | Lenalidomide in multiple myeloma: current role and future directions. ( Bizzari, JP; Jacques, C; Knight, RD; Tozer, A; Zeldis, JB, 2010) |
| "Lenalidomide is a potent, novel thalidomide analog that has demonstrated promising clinical activity in patients with relapsed or refractory multiple myeloma (MM)." | 4.84 | Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. ( Tariman, JD, 2007) |
| "Studies of bortezomib, thalidomide, and lenalidomide have shown promising clinical activity in relapsed/refractory multiple myeloma (MM)." | 4.84 | Management of relapsed and relapsed refractory myeloma. ( Dimopoulos, MA; Kastritis, E; Mitsiades, CS; Richardson, PG, 2007) |
| "The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial." | 4.83 | A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myeloma. ( Glasmacher, A; Goldschmidt, H; Gorschlüter, M; Hahn, C; Hoffmann, F; Naumann, R; Orlopp, K; Schmidt-Wolf, I; von Lilienfeld-Toal, M, 2006) |
| "To detail the dyspnea encountered in women receiving thalidomide as therapy for advanced ovarian cancer." | 4.82 | Dyspnea during thalidomide treatment for advanced ovarian cancer. ( Dizon, DS; Gordinier, ME, 2005) |
| "A man in his late 60s who had received the first cycle of a chemotherapeutic regimen of ixazomib, lenalidomide, and dexamethasone for multiple myeloma presented to the dermatologic clinic with a 10-day history of fever and tender lesions on the neck and trunk." | 4.31 | Fever, Pancytopenia, and Tender Erythematous Plaques in a Patient With Multiple Myeloma. ( Katayama, S; Ota, M; Yamaga, M, 2023) |
| "In cohort C of the phase 2 MM-014 trial, the efficacy and safety of pomalidomide, dexamethasone, and daratumumab therapy were investigated in 18 Japanese patients with relapsed/refractory multiple myeloma (RRMM) after their most recent regimen of lenalidomide-based therapy (NCT01946477)." | 4.12 | Pomalidomide, dexamethasone, and daratumumab in Japanese patients with relapsed or refractory multiple myeloma after lenalidomide-based treatment. ( Chung, W; Iida, S; Iwasaki, H; Kuroda, J; Kuwayama, S; Lee, K; Matsue, K; Matsumoto, M; Nishio, M; Sugiura, I; Sunami, K, 2022) |
| "In the pivotal phase III, randomized, multicenter ICARIA-MM study (NCT02990338), isatuximab plus pomalidomide and dexamethasone (Isa-Pd) improved progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) in the overall population of patients with relapsed/refractory multiple myeloma." | 4.12 | Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. ( Campana, F; Huang, SY; Iida, S; Ikeda, T; Iyama, S; Kaneko, H; Kim, JS; Kim, K; Koh, Y; Lee, JH; Lin, TL; Matsumoto, M; Min, CK; Shimazaki, C; Sunami, K; Suzuki, K; Tada, K; Uchiyama, M; Wang, MC; Yeh, SP, 2022) |
| "The phase 3 APOLLO study demonstrated significantly better progression-free survival (PFS) and clinical responses with daratumumab, pomalidomide, and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM)." | 4.12 | Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. ( Bathija, S; Berringer, H; Dwarakanathan, HR; He, J; Heeg, B; Johnston, S; Kampfenkel, T; Lam, A; Mackay, E; Mendes, J; Ruan, H, 2022) |
| "For patients with multiple myeloma (MM) that relapsed after treatment with bortezomib- and lenalidomide-based regimens, there were no other treatment options in Korea until 2016." | 3.96 | Analysis of the Efficacy of Thalidomide Plus Dexamethasone-Based Regimens in Patients With Relapsed/Refractory Multiple Myeloma Who Received Prior Chemotherapy, Including Bortezomib and Lenalidomide: KMM-166 Study. ( Eom, HS; Jung, KS; Kim, HJ; Kim, JS; Kim, K; Kim, SH; Lee, JJ; Lee, JO; Min, CK; Shin, HJ, 2020) |
| "In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients." | 3.96 | Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma. ( Anttila, P; Basu, S; Ben-Yehuda, D; Biyukov, T; Byeff, P; Cascavilla, N; Dhanasiri, S; Dimopoulos, M; Grote, L; Guo, S; Hayden, PJ; Hus, M; Johnson, P; Kanate, AS; Krauth, MT; Larocca, A; Lucio, P; Mendeleeva, L; Moreau, P; Muelduer, E; Richardson, P; Rodríguez-Otero, P; Vural, F; Weisel, K; Yagci, M; Yu, X, 2020) |
| "Although there are several case reports of progressive multifocal leukoencephalopathy (PML) in multiple myeloma (MM), there are few reports of cases associated with pomalidomide." | 3.96 | Pomalidomide-associated progressive multifocal leukoencephalopathy in multiple myeloma: cortical susceptibility-weighted imaging hypointense findings prior to clinical deterioration. ( Ichinohe, T; Ishibashi, H; Kikumto, M; Maruyama, H; Nakamichi, K; Saijo, M; Takahashi, T; Takebayashi, Y; Ueno, H; Umemoto, K; Yasutomi, H, 2020) |
| "Addition of daratumumab to pomalidomide and low-dose dexamethasone (LoDEX) is a safe and effective combination for relapsed/refractory multiple myeloma treatment." | 3.96 | Immunomodulation in Pomalidomide, Dexamethasone, and Daratumumab-Treated Patients with Relapsed/Refractory Multiple Myeloma. ( Agarwal, A; Amatangelo, MD; Bahlis, NJ; Chung, W; Neri, P; Parekh, S; Pierceall, WE; Rahman, A; Serbina, N; Siegel, DS; Thakurta, A; Van Oekelen, O; Young, M, 2020) |
| "In conclusion, pomalidomide and dexamethasone has limited efficacy in patients with advanced MM and soft-tissue plasmacytomas." | 3.91 | Pomalidomide-dexamethasone for treatment of soft-tissue plasmacytomas in patients with relapsed / refractory multiple myeloma. ( Abella, E; Bladé, J; Cabezudo, E; Cibeira, MT; Clapés, V; Escoda, L; Fernández de Larrea, C; García-Guiñón, A; Gironella, M; Granell, M; Isola, I; Jiménez-Segura, R; López-Pardo, J; Oriol, A; Rosiñol, L; Soler, JA; Tovar, N, 2019) |
| "This phase Ib study evaluated oprozomib, an oral proteasome inhibitor, plus pomalidomide-dexamethasone in relapsed/refractory multiple myeloma (RRMM)." | 3.91 | Oprozomib, pomalidomide, and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma. ( Berdeja, JG; Berenson, JR; Chang, YL; Klippel, Z; Lyons, RM; Niesvizky, R; Rifkin, RM; Shah, J; Stadtmauer, EA; Usmani, S, 2019) |
| "We performed analyses of the randomized phase 3 ASPIRE and ENDEAVOR trials to investigate the efficacy of carfilzomib among subgroups of relapsed or refractory multiple myeloma patients who had early or late disease relapse following initiation of the immediately prior therapy." | 3.88 | Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. ( Blaedel, J; DeCosta, L; Goldschmidt, H; Leleu, X; Mateos, MV; Mikhael, J; Obreja, M; San-Miguel, J; Szabo, Z; Zhou, L, 2018) |
| "Lenalidomide in combination with dexamethasone (Len-dex) represents a highly effective treatment in relapsed/refractory multiple myeloma (RRMM) patients." | 3.85 | Secondary primary malignancies during the lenalidomide-dexamethasone regimen in relapsed/refractory multiple myeloma patients. ( Atenafu, EG; Chen, C; Chu, CM; Kotchetkov, R; Kukreti, V; Masih-Khan, E; Reece, DE; Tiedemann, R; Trudel, S, 2017) |
| "We analyzed the treatment responses, toxicities, and survival outcomes of patients with relapsed or refractory multiple myeloma who received daily thalidomide, cyclophosphamide, and dexamethasone (CTD) or daily thalidomide, melphalan, and prednisolone (MTP) at 17 medical centers in Korea." | 3.85 | Efficacy and toxicity of the combination chemotherapy of thalidomide, alkylating agent, and steroid for relapsed/refractory myeloma patients: a report from the Korean Multiple Myeloma Working Party (KMMWP) retrospective study. ( Choi, YS; Eom, HS; Han, JJ; Kang, HJ; Kim, HJ; Kim, K; Kim, MK; Kim, SH; Kwon, J; Lee, JH; Lee, JJ; Lee, JO; Lee, WS; Min, CK; Moon, JH; Yoon, DH; Yoon, SS, 2017) |
| "Here we discuss the case of a heavily pretreated male patient with relapsed-refractory multiple myeloma and previous monoclonal gammopathy of undetermined significance who initiated a fifth-line treatment with pomalidomide (4 mg orally, days 1-21 of a 28-day cycle) and low-dose dexamethasone (40 mg weekly orally)." | 3.85 | Pomalidomide experience: an effective therapeutic approach with immunomodulatory drugs in a patient with relapsed-refractory multiple myeloma. ( Ancora, F; Calafiore, V; Consoli, ML; Conticello, C; Di Raimondo, F; La Fauci, A; Parisi, M; Romano, A, 2017) |
| "We describe the case of a 54-year-old woman with relapse of multiple myeloma 3 years after myeloablative allogeneic stem cell transplant who developed abdominal pain and bloody diarrhea following 7 months of lenalidomide therapy." | 3.83 | Ischemic colitis diagnosed by magnetic resonance imaging during lenalidomide treatment in a patient with relapsed multiple myeloma. ( Bucalossi, A; Cioffi Squitieri, N; Guerrini, S; Mazzei, FG; Mazzei, MA; Volterrani, L, 2016) |
| "The IFM2009-02 trial studied pomalidomide (4 mg daily, 21/28 versus 28/28) and dexamethasone in very advanced relapsed or refractory multiple myeloma (RRMM)." | 3.83 | Safe and prolonged survival with long-term exposure to pomalidomide in relapsed/refractory myeloma. ( Arnulf, B; Attal, M; Avet-Loiseau, H; Banos, A; Benbouker, L; Brechiniac, S; Caillot, D; Decaux, O; Escoffre-Barbe, M; Facon, T; Fermand, JP; Fouquet, G; Garderet, L; Hulin, C; Karlin, L; Kolb, B; Leleu, X; Macro, M; Marit, G; Mathiot, C; Moreau, P; Pegourie, B; Petillon, MO; Richez, V; Rodon, P; Roussel, M; Royer, B; Stoppa, AM; Wetterwald, M, 2016) |
| "To compare the outcomes of patients with relapsed or refractory multiple myeloma (RRMM) who were treated with lenalidomide combined with high versus low dose of dexamethasone." | 3.83 | Lenalidomide with low- or intermediate-dose dexamethasone in patients with relapsed or refractory myeloma. ( Christoulas, D; Dimopoulos, MA; Eleutherakis-Papaiakovou, E; Gavriatopoulou, M; Kalapanida, D; Kanellias, N; Kastritis, E; Migkou, M; Roussou, M; Terpos, E; Zagouri, F, 2016) |
| "Neutropenia is a major dose-limiting toxicity associated with lenalidomide in relapsed/refractory multiple myeloma (MM)." | 3.81 | Intermittent granulocyte colony-stimulating factor for neutropenia management in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone. ( Atenafu, EG; Chen, C; Kukreti, V; Masih-Khan, E; Reece, DE; Sun, HL; Trudel, S; Winter, A; Yeboah, E, 2015) |
| "Clinical studies evaluating the efffectiveness of pomalidomide based regimens on response and safety for patients with refractory and relapsed multiple myeloma were identified using a predefined search strategy." | 3.81 | Pooled analysis of pomalidomide for treating patients with multiple myeloma. ( Sun, JJ; Yang, HL; Zhang, C; Zhou, J, 2015) |
| "To explore the clinical efficacies and toxicities of lenalidomide combination chemotherapy in the treatment of relapsing or refractory multiple myeloma (MM) patients." | 3.81 | [Clinical observations of lenalidomide combination chemotherapy for relapsing or refractory multiple myeloma]. ( An, N; Chen, S; Hu, Y; Huang, Z; Li, X; Shen, M; Sun, W; Zhan, X; Zhang, J; Zhong, Y, 2015) |
| "The authors performed a single-institution study comparing 3 salvage chemotherapy regimens in 107 patients with recurrent/refractory multiple myeloma: dexamethasone, cyclophosphamide, etoposide, and cisplatin (DCEP) in 52 patients; bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide (VTD-PACE) in 22 patients; and cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) in 33 patients." | 3.81 | A comparison of salvage infusional chemotherapy regimens for recurrent/refractory multiple myeloma. ( Alsina, M; Baz, RC; Fulp, W; Griffin, PT; Ho, VQ; Nishihori, T; Shain, KH, 2015) |
| "HIF-1α mRNA and protein were evaluated in patients with multiple myeloma endothelial cells (MMEC) at diagnosis, at relapse after bortezomib- or lenalidomide-based therapies or on refractory phase to these drugs, at remission; in endothelial cells of patients with monoclonal gammapathies of undetermined significance (MGUS; MGECs), and of those with benign anemia (controls)." | 3.80 | HIF-1α of bone marrow endothelial cells implies relapse and drug resistance in patients with multiple myeloma and may act as a therapeutic target. ( Angelucci, E; Annese, T; Berardi, S; Caivano, A; Catacchio, I; Dammacco, F; De Luisi, A; Derudas, D; Ditonno, P; Frassanito, MA; Guarini, A; Minoia, C; Moschetta, M; Nico, B; Piccoli, C; Ria, R; Ribatti, D; Ruggieri, S; Ruggieri, V; Vacca, A, 2014) |
| "Initial clinical trials demonstrated that lenalidomide monotherapy has a significant activity against some subtypes of lymphoma, but in diffuse large B-cell lymphoma (DLBCL) its activity is limited." | 3.80 | Efficacy and safety of lenalinomide combined with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma. ( Aurran-Schleinitz, T; Blaise, D; Bouabdallah, R; Broussais-Guillaumot, F; Chetaille, B; Coso, D; Esterni, B; Ivanov, V; Olive, D; Schiano, JM; Stoppa, AM, 2014) |
| " Total therapy trials (TT; TT2(-/+) thalidomide) and TT3 (TT3a with bortezomib, thalidomide; TT3b with additional lenalidomide) offered the opportunity to examine the contribution of these immune-modulatory agents to MDS-associated cytogenetic abnormalities (MDS-CA) and clinical MDS or acute leukemia ("clinical MDS/AL")." | 3.79 | Risk factors for MDS and acute leukemia following total therapy 2 and 3 for multiple myeloma. ( Abdallah, AO; Bailey, C; Barlogie, B; Chauhan, N; Cottler-Fox, M; Crowley, J; Epstein, J; Heuck, CJ; Hoering, A; Johann, D; Muzaffar, J; Petty, N; Rosenthal, A; Sawyer, J; Sexton, R; Singh, Z; Usmani, SZ; van Rhee, F; Waheed, S; Yaccoby, S, 2013) |
| "Lenalidomide and bortezomib have not been compared prospectively and are currently used in sequence for patients with multiple myeloma; however, it is unknown whether a sequence of administration could result in improved outcomes." | 3.79 | Sequence of novel agents in multiple myeloma: an instrumental variable analysis. ( Alsina, M; Baz, R; Dalton, WS; Djulbegovic, B; Ho, VQ; Miladinovic, B; Nishihori, T; Ochoa-Bayona, JL; Patel, A; Shain, KH; Sullivan, DM, 2013) |
| "The novel agents bortezomib and lenalidomide improve outcomes in multiple myeloma, yet most patients will relapse after exhausting treatment." | 3.79 | Pomalidomide in the treatment of relapsed multiple myeloma. ( Forsberg, PA; Mark, TM, 2013) |
| "Lenalidomide in combination with dexamethasone (Len/Dex) is indicated for patients with recurrent/refractory multiple myeloma (RRMM) who were treated with 1 prior therapy until evidence of disease progression." | 3.79 | Efficacy and safety profile of long-term exposure to lenalidomide in patients with recurrent multiple myeloma. ( Avet Loiseau, H; Bonnet, S; Debarri, H; Demarquette, H; Facon, T; Fouquet, G; Gay, J; Guidez, S; Herbaux, C; Hulin, C; Leleu, X; Michel, J; Miljkovic, D; Perrot, A; Serrier, C; Tardy, S, 2013) |
| "The treatment of multiple myeloma (MM) has changed with the advent of thalidomide, bortezomib, and lenalidomide, the so-called novel agents (NAs)." | 3.77 | Novel agents improve survival of transplant patients with multiple myeloma including those with high-risk disease defined by early relapse (<12 months). ( Barnett, MJ; Broady, R; Connors, JM; Forrest, DL; Hamata, L; Hogge, DE; Mourad, YA; Nantel, SH; Narayanan, S; Nevill, TJ; Nitta, J; Power, MM; Shepherd, JD; Smith, CA; Song, KW; Sutherland, HJ; Toze, CL; Venner, CP, 2011) |
| "An expert panel convened to reach a consensus regarding the optimal use of lenalidomide in combination with dexamethasone (Len/Dex) in patients with relapsed or refractory multiple myeloma (RRMM)." | 3.77 | Optimizing the use of lenalidomide in relapsed or refractory multiple myeloma: consensus statement. ( Attal, M; Beksaç, M; da Costa, FL; Davies, FE; Delforge, M; Dimopoulos, MA; Einsele, H; Hajek, R; Harousseau, JL; Ludwig, H; Mellqvist, UH; Morgan, GJ; Palumbo, A; San-Miguel, JF; Sonneveld, P; Zweegman, S, 2011) |
| "A total of 106 relapsed or refractory multiple myeloma patients received lenalidomide 25mg plus dexamethasone as salvage therapy; 80 patients progressed on thalidomide treatment (thalidomide-resistant) and 26 patients discontinued thalidomide in at least partial remission (thalidomide-sensitive)." | 3.77 | Previous thalidomide therapy may not affect lenalidomide response and outcome in relapse or refractory multiple myeloma patients. ( Benevolo, G; Berruti, A; Boccadoro, M; Bringhen, S; Caravita, T; Cavallo, F; Corradini, P; Gay, F; Guglielmelli, T; Montefusco, V; Offidani, M; Palumbo, A; Petrucci, MT; Piro, E; Rrodhe, S; Saglio, G, 2011) |
| "There was no association between functional CYP2C19 and CYP2D6 alleles and treatment outcome in multiple myeloma patients treated with cyclophosphamide, thalidomide or bortezomib." | 3.76 | No influence of the polymorphisms CYP2C19 and CYP2D6 on the efficacy of cyclophosphamide, thalidomide, and bortezomib in patients with Multiple Myeloma. ( Abildgaard, N; Andersen, NF; Gimsing, P; Gregersen, H; Klausen, TW; Rasmussen, HB; Søeby, K; Vangsted, AJ; Vogel, U; Werge, T, 2010) |
| " Thalidomide is an immunomodulatory drug with numerous properties that has proven effective in relapsed multiple myeloma and, to a lesser extent, in other hematologic diseases." | 3.73 | Single-agent thalidomide induces response in T-cell lymphoma. ( Bilger, K; Bouabdallah, R; Damaj, G; Gastaut, JA; Mohty, M; Vey, N, 2005) |
| "Remarkable results of the treatment of refractory multiple myeloma with thalidomide have been reported." | 3.72 | Low dose thalidomide in patients with relapsed or refractory multiple myeloma. ( Ackermann, J; Dimou, G; Drach, J; Gisslinger, H; Kees, M; Lechner, K; Sillaber, C, 2003) |
| "The aim of this study was to assess the prognostic value of pretreatment clinical and laboratory parameters in refractory or relapsed multiple myeloma (MM) patients who have a long-term response to thalidomide (THAL), lasting at least 18 months." | 3.72 | An evaluation of factors predicting long-term response to thalidomide in 234 patients with relapsed or resistant multiple myeloma. ( Ciepluch, H; Dmoszynska, A; Hellmann, A; Hus, I; Hus, M; Jawniak, D; Kloczko, J; Konopka, L; Manko, J; Robak, T; Skotnicki, A; Soroka-Wojtaszko, M; Sulek, K; Wolska-Smolen, T, 2004) |
| " The purpose of our study was to compare postcontrast T1-weighted imaging with dynamic, contrast-enhanced T2*-weighted echo-planar imaging in the evaluation of the response of recurrent malignant gliomas to thalidomide and carboplatin." | 3.70 | Dynamic contrast-enhanced T2-weighted MR imaging of recurrent malignant gliomas treated with thalidomide and carboplatin. ( Cha, S; Glass, J; Gruber, ML; Johnson, G; Knopp, EA; Litt, A; Lu, S; Zagzag, D, 2000) |
| "Thalidomide was administered as a therapeutic agent for chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplantation in a patient with breast cancer." | 3.69 | Thalidomide-induced perioral neuropathy. ( Elad, S; Galili, D; Garfunkel, AA; Or, R, 1997) |
| " The novel quadruplet combination was overall well-tolerated, with clinically manageable adverse events." | 3.11 | A phase 2 trial of the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high-risk relapsed/refractory multiple myeloma. ( Berenson, JR; Eades, B; Eshaghian, S; Ghermezi, M; Lim, S; Martinez, D; Schwartz, G; Spektor, TM; Swift, RA; Vescio, R; Yashar, D, 2022) |
| "This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM)." | 3.01 | Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma. ( Anttila, P; Bringhen, S; Capra, M; Cavo, M; Cole, C; Dimopoulos, M; Gasparetto, C; Hellet, M; Hungria, V; Jenner, M; Macé, S; Paiva, B; Ruiz, EY; Saleem, R; Vij, R; Vorobyev, V; Yin, JY, 2021) |
| "Treatment of multiple myeloma is not curative, but targeting CD38 improves patient survival." | 2.94 | MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. ( Agis, H; Blank, A; Blau, IW; Chatterjee, M; Einsele, H; Engelhardt, M; Ferstl, B; Goldschmidt, H; Griese, J; Härtle, S; Jarutat, T; Peschel, C; Raab, MS; Röllig, C; Schub, N; Weirather, J; Weisel, K; Winderlich, M, 2020) |
| "Treatment for relapsed/refractory multiple myeloma (RRMM) remains an unmet need." | 2.87 | Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA Phase III study design. ( Anderson, KC; Attal, M; Campana, F; Corzo, K; Hui, AM; Le-Guennec, S; Richardson, PG; Risse, ML, 2018) |
| " This phase I/II study was conducted to determine the maximum tolerated dose (MTD), safety, and efficacy of lenalidomide combined with panobinostat in relapsed/refractory HL." | 2.84 | A Phase I/II Trial of Panobinostat in Combination With Lenalidomide in Patients With Relapsed or Refractory Hodgkin Lymphoma. ( Bartlett, NL; Blum, KA; Christian, BA; Devine, SM; Fehniger, TA; Jaglowski, SM; Maly, JJ; Phelps, MA; Sexton, JL; Wagner-Johnston, ND; Wei, L; Zhu, X, 2017) |
| "Lenalidomide is a suitable candidate for long-lasting maintenance as it is an oral drug, active against DLBCL that can be taken for years with an acceptable toxicity profile." | 2.84 | Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. ( Arcari, A; Bertoldero, G; Calimeri, T; Cecchetti, C; Chiozzotto, M; Couto, S; Fabbri, A; Ferreri, AJ; Frezzato, M; Govi, S; Nonis, A; Ponzoni, M; Re, A; Ren, Y; Rocco, AD; Rusconi, C; Sassone, M; Scarfò, L; Spina, M; Stelitano, C; Zaja, F; Zambello, R, 2017) |
| "Oral lenalidomide (10 mg daily) was started on day 9 and continued for as long as a clinical benefit was observed." | 2.82 | Ofatumumab and Lenalidomide for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Correlation between Responses and Immune Characteristics. ( Burger, JA; Calin, G; Faderl, S; Falchi, L; Ferrajoli, A; Gao, H; Keating, MJ; O'Brien, S; Reuben, JM; Rezvani, K; Shaim, H; Ten Hacken, E; Van Roosbroeck, K; Vitale, C; Wang, X; Wierda, WG, 2016) |
| "Lenalidomide 10 mg/d was identified as the MTD because, in the 15 mg cohort, one patient experienced dose-limiting toxicity (grade 3 angioedema) and two patients had mobilization failure." | 2.82 | Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group. ( Caballero, D; Canales, M; Dlouhy, I; González-Barca, E; López-Guillermo, A; Martín, A; Montes-Moreno, S; Ocio, EM; Redondo, AM; Salar, A, 2016) |
| "To investigate the clinical efficacy and safety between CHOPE regimen alone and it combined with thalidomide for relapsed and refractory non-Hodgkin's lymphoma." | 2.82 | [Clinical Efficacy Comparison between CHOPE Regimen alone and It Combined with Thalidomide for Relapsed and Refractory Non-Hodgkin's Lymphoma]. ( Yang, YZ, 2016) |
| "Despite novel therapeutic agents, most multiple myeloma (MM) patients eventually relapse." | 2.82 | Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantatio ( Baertsch, MA; Fenk, R; Goerner, M; Goldschmidt, H; Graeven, U; Haenel, M; Hielscher, T; Hillengaß, J; Ho, AD; Hose, D; Jauch, A; Klein, S; Kunz, C; Lindemann, HW; Luntz, S; Mai, EK; Martin, H; Merz, M; Nogai, A; Noppeney, R; Raab, MS; Reimer, P; Salwender, H; Scheid, C; Schlenzka, J; Schmidt-Hieber, M; Schmidt-Wolf, IG; Weisel, K; Wuchter, P, 2016) |
| "We analyzed the prognostic impact of cytogenetic aberrations by fluorescence in situ hybridization at different cutoff values in a cohort of 333 patients with newly diagnosed myeloma and 92 patients with relapsed myeloma." | 2.80 | The impact of clone size on the prognostic value of chromosome aberrations by fluorescence in situ hybridization in multiple myeloma. ( Acharya, C; An, G; Anderson, KC; Cheng, T; Deng, S; Feng, X; Hao, M; Li, C; Li, Q; Li, Z; Qi, J; Qin, X; Qiu, L; Ru, K; Shi, L; Sui, W; Tai, YT; Wang, J; Xu, Y; Yi, S; Zang, M; Zhao, J; Zhao, Y; Zou, D, 2015) |
| " Here we evaluated the clinical and pharmacodynamic effects of continuous or intermittent dosing strategies of pomalidomide/dexamethasone in lenalidomide-refractory myeloma in a randomized trial." | 2.80 | Clinical and pharmacodynamic analysis of pomalidomide dosing strategies in myeloma: impact of immune activation and cereblon targets. ( Breider, M; Cooper, D; Couto, S; Das, R; Deng, Y; Dhodapkar, KM; Dhodapkar, MV; Hansel, D; Kocoglu, M; Koduru, S; Ren, Y; Sehgal, K; Seropian, S; Thakurta, A; Vasquez, J; Verma, R; Wang, M; Yao, X; Zhang, L, 2015) |
| "Preclinical models show that an antiangiogenic regimen at low-dose daily (metronomic) dosing may be effective against chemotherapy-resistant tumors." | 2.79 | A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children with recurrent or progressive cancer. ( Allen, JC; Bendel, AE; Campigotto, F; Chi, SN; Chordas, CA; Comito, MA; Goldman, S; Hubbs, SM; Isakoff, MS; Khatib, ZA; Kieran, MW; Kondrat, L; Manley, PE; Neuberg, DS; Pan, WJ; Pietrantonio, JB; Robison, NJ; Rubin, JB; Turner, CD; Werger, AM; Zimmerman, MA, 2014) |
| "Lenalidomide has dual antiangiogenic and immunomodulatory properties and confirmed antitumor activity in hematologic malignancies." | 2.79 | A phase II study of lenalidomide in platinum-sensitive recurrent ovarian carcinoma. ( Berton-Rigaud, D; Fabbro, M; Favier, L; Lesoin, A; Lortholary, A; Mari, V; Pujade-Lauraine, E; Ray-Coquard, I; Selle, F; Sevin, E, 2014) |
| " The most common grade 3 or 4 adverse events were neutropenia (38 [35%] of 110 patients), muscle pain (ten [9%]), rash (eight [7%]), cough, dyspnoea, or other pulmonary symptoms (five [5%]), fatigue (five [5%]), thrombosis (five [5%]), and thrombocytopenia (four [4%])." | 2.79 | Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial. ( Baladandayuthapani, V; Claret, LC; Davis, RE; Fanale, MA; Fayad, LE; Feng, L; Fowler, NH; Hagemeister, FB; Kwak, LW; McLaughlin, P; Muzzafar, T; Nastoupil, L; Neelapu, SS; Oki, Y; Orlowski, RZ; Rawal, S; Romaguera, JE; Samaniego, F; Shah, J; Tsai, KY; Turturro, F; Wang, M; Westin, JR, 2014) |
| "We conducted a phase I dose escalation study to determine the maximal tolerated dose of bortezomib that could be combined with standard dose lenalidomide in patients with MDS or AML." | 2.78 | Phase I dose escalation study of bortezomib in combination with lenalidomide in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). ( Amrein, PC; Attar, EC; Ballen, KK; Deangelo, DJ; Fathi, AT; Foster, J; Fraser, JW; McAfee, S; Neuberg, D; Steensma, DP; Stone, RM; Wadleigh, M, 2013) |
| "The lenalidomide dose was 25 mg/day, and was adjusted according to baseline renal function." | 2.78 | A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial. ( Ai, H; Cai, Z; Chen, F; Chen, N; Du, X; Hou, J; Jin, J; Ke, X; Li, X; Mei, J; Meng, F; Wang, J; Wortman-Vayn, H; Wu, D; Yu, L; Zhang, J; Zhou, DB, 2013) |
| "Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL." | 2.78 | Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. ( Czuczman, MS; Haioun, C; Li, J; Polikoff, J; Prandi, K; Reeder, CB; Tilly, H; Vose, JM; Witzig, TE; Zhang, L; Zinzani, PL, 2013) |
| "Treatment with lenalidomide was associated with global changes in immunoreactivity to a number of prostate-associated antigens, as well as with changes in circulating levels of the T(H) 2 cytokines IL-4, IL-5, IL-10, and IL-13." | 2.77 | Lenalidomide modulates IL-8 and anti-prostate antibody levels in men with biochemically recurrent prostate cancer. ( Antonarakis, ES; Carducci, M; Drake, CG; Eisenberger, MA; Keizman, D; McNeel, DG; Smith, HA; Thoburn, CJ; Zabransky, DJ; Zahurak, M, 2012) |
| "Lenalidomide is an immunomodulatory agent with antitumor activity in B-cell malignancies." | 2.76 | An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. ( Bouabdallah, R; Buckstein, R; Czuczman, MS; Ervin-Haynes, AL; Guo, P; Haioun, C; Pietronigro, D; Polikoff, JA; Reeder, CB; Tilly, H; Vose, JM; Witzig, TE; Zinzani, PL, 2011) |
| "Lenalidomide was shown to have significant single-agent activity in relapsed aggressive non-Hodgkin's lymphoma (NHL)." | 2.76 | Lenalidomide can be safely combined with R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I study. ( Ansell, SM; Habermann, TM; Inwards, DJ; Johnston, PB; Klebig, RR; LaPlant, B; Macon, WR; Micallef, IN; Nowakowski, GS; Porrata, LF; Reeder, CB; Rivera, CE; Witzig, TE, 2011) |
| "Lenalidomide was well tolerated but did not show efficacy in heavily pretreated patients with cisplatin-refractory and multiply relapsed germ cell tumors." | 2.75 | Lenalidomide in patients with cisplatin-refractory and multiply relapsed germ cell tumors. ( Bokemeyer, C; Honecker, F; Oechsle, K, 2010) |
| "Thalidomide was not more effective than tamoxifen in delaying recurrence or death but was more toxic." | 2.75 | Randomized phase III trial of tamoxifen versus thalidomide in women with biochemical-recurrent-only epithelial ovarian, fallopian tube or primary peritoneal carcinoma after a complete response to first-line platinum/taxane chemotherapy with an evaluation ( Benbrook, DM; Brady, MF; Darcy, KM; Edmonds, P; Hurteau, JA; Ivanov, I; Mannel, RS; McGuire, WP; Pearl, ML; Tewari, KS; Zanotti, K, 2010) |
| "Lenalidomide has activity in a variety of hematologic malignancies, including non-Hodgkin's lymphoma (NHL)." | 2.73 | Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. ( Cole, CE; Ervin-Haynes, A; Habermann, TM; Justice, G; Lam, W; Lossos, IS; McBride, K; Pietronigro, D; Takeshita, K; Tuscano, JM; Vose, JM; Wiernik, PH; Wride, K; Zeldis, JB, 2008) |
| " The majority of adverse events were grades 1-2, including fatigue (25/80 cycles), nausea/vomiting (23/80), constipation (13/80), abdominal pain (17/80), rash (12/80), neutropenia (12/80), and anemia (12/80)." | 2.73 | Safety and efficacy of lenalidomide (Revlimid) in recurrent ovarian and primary peritoneal carcinoma. ( Chan, JK; Guo, HY; Husain, A; Teng, NN; Zhang, MM, 2007) |
| "Thalidomide is an antiangiogenic agent with immune modulating potential." | 2.73 | A prospective randomized trial of thalidomide with topotecan compared with topotecan alone in women with recurrent epithelial ovarian carcinoma. ( Abu-Ghazaleh, SZ; Argenta, PA; Bliss, RL; Boente, MP; Carson, LF; Chen, MD; Downs, LS; Geller, MA; Ghebre, R; Judson, PL; Nahhas, WA, 2008) |
| "Treatment with lenalidomide was associated with an OR rate of 31% in patients with 11q or 17p deletion, of 24% in patients with unmutated V(H), and of 25% in patients with fludarabine-refractory disease." | 2.73 | Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia. ( Cohen, EN; Estrov, Z; Faderl, S; Ferrajoli, A; Gao, H; Keating, MJ; Lee, BN; Li, C; O'Brien, SM; Reuben, JM; Schlette, EJ; Wen, S; Wierda, WG, 2008) |
| "Thalidomide is an anti-angiogenesis agent that has shown activity in some solid tumors." | 2.72 | Safety and efficacy of thalidomide in recurrent epithelial ovarian and peritoneal carcinoma. ( Chan, JK; Cheung, MK; Ciaravino, G; Husain, A; Manuel, MR; Teng, NN, 2006) |
| "Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle." | 2.72 | Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study. ( Bernstein, ZP; Byrne, C; Chanan-Khan, A; Chrystal, C; Czuczman, MS; Goodrich, DW; Hernandez-Ilizaliturri, F; Lawrence, D; Miller, KC; Mohr, A; Musial, L; Padmanabhan, S; Porter, CW; Spaner, D; Starostik, P; Takeshita, K; Wallace, P, 2006) |
| "Thalidomide was well tolerated: the most common side effects were constipation (76." | 2.71 | Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004) |
| "Thalidomide has recently been recognized as an effective new agent for previously untreated, refractory or relapsed myeloma." | 2.71 | Low-dose thalidomide for multiple myeloma: interim analysis of a compassionate use program. ( Gastl, G; Mitterer, M; Spizzo, G; Steurer, M, 2004) |
| "Thalidomide was given orally at a daily dose of 200 mg/day, which was then escalated every 2 weeks by 200 mg/day as tolerated to a maximum of 800 mg/day." | 2.71 | Phase II study of thalidomide in patients with metastatic malignant melanoma. ( Cancela, AI; Costa, TD; Di Leone, LP; Fernandes, S; Reiriz, AB; Richter, MF; Schwartsmann, G, 2004) |
| "Thalidomide was initiated at 200 mg;3>daily and increased to a target dose of 1000 mg daily." | 2.70 | Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. ( Abbruzzese, JL; El-Naggar, AK; Ginsberg, LE; Glisson, BS; Herbst, RS; Hong, WK; Khuri, FR; Lawhorn, KN; Myers, JN; Pluda, JM; Roach, JS; Shin, DM; Steinhaus, GD; Teddy, S; Thall, PF; Tseng, JE; Wang, X; Zentgraf, RE, 2001) |
| "Thalidomide is a well-tolerated drug that may have some activity in the treatment of recurrent glioblastoma." | 2.70 | Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme. ( Bell, DR; Biggs, M; Boyle, FM; Cook, R; Levi, JA; Little, N; Marx, GM; McCowatt, S; Pavlakis, N; Wheeler, HR, 2001) |
| " The treatment outcomes of MAbs versus HDACi in combination with bortezomib or lenalidomide plus dexamethasone remain unknown." | 2.58 | Monoclonal Antibodies versus Histone Deacetylase Inhibitors in Combination with Bortezomib or Lenalidomide plus Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma: An Indirect-Comparison Meta-Analysis of Randomized Controlled Trial ( Chen, X; Feng, J; Gao, G; Shen, H; Tang, H; Xu, L; Zhang, N; Zheng, Y, 2018) |
| "Waldenström macroglobulinemia is defined by the presence of monoclonal immunoglobulin IgM type (M-IgM) and evidence of lymphoplasmacytic bone marrow infiltration." | 2.53 | [Changes in the prognosis and treatment of Waldenström macroglobulinemia. Literature overview and own experience]. ( Adam, Z; Král, Z; Krejčí, M; Mayer, J; Pour, L; Pourová, E; Ševčíková, E; Ševčíková, S, 2016) |
| "Recent developments in the treatment of multiple myeloma have led to improvements in response rates and to increased survival; however, relapse is inevitable in almost all patients." | 2.52 | Current treatment landscape for relapsed and/or refractory multiple myeloma. ( Anderson, KC; Dimopoulos, MA; Moreau, P; Richardson, PG, 2015) |
| "Waldenstrom macroglobulinemia (WM) is a B-cell lymphoplasmacytic lymphoma characterized by monoclonal immunoglobulin M protein in the serum and infiltration of bone marrow with lymphoplasmacytic cells." | 2.52 | Waldenstrom macroglobulinemia: prognosis and management. ( Oza, A; Rajkumar, SV, 2015) |
| "Lenalidomide is an approved medication for relapsed mantle cell lymphoma in patients who received at least two lines of therapy, including bortezomib." | 2.52 | Lenalidomide for mantle cell lymphoma. ( Goy, AH; Skarbnik, AP, 2015) |
| "Recent developments in the treatment of multiple myeloma (MM) have led to improvements in response rates and to increased survival." | 2.52 | Multiple myeloma: from front-line to relapsed therapies. ( Moreau, P; Touzeau, C, 2015) |
| "Despite many recent advances in the treatment of multiple myeloma, the course of the disease is characterized by a repeating pattern of periods of remission and relapse as patients cycle through the available treatment options." | 2.52 | Maintenance therapy for multiple myeloma in the era of novel agents. ( Facon, T, 2015) |
| "Pomalidomide is a potent second-generation immunomodulatory agent with direct antiproliferative, pro-apoptotic, and antiangiogenic effects, as well as modulatory effects on bone resorption and on the immune system." | 2.50 | [Pomalidomide in the treatment of relapsed and refractory multiple myeloma]. ( Bátorová, A; Mistrík, M; Roziaková, L, 2014) |
| "The treatment of multiple myeloma (MM) has undergone significant developments in recent years." | 2.46 | Current multiple myeloma treatment strategies with novel agents: a European perspective. ( Beksac, M; Bladé, J; Boccadoro, M; Cavenagh, J; Cavo, M; Dimopoulos, M; Drach, J; Einsele, H; Facon, T; Goldschmidt, H; Harousseau, JL; Hess, U; Ketterer, N; Kropff, M; Ludwig, H; Mendeleeva, L; Morgan, G; Palumbo, A; Plesner, T; San Miguel, J; Shpilberg, O; Sondergeld, P; Sonneveld, P; Zweegman, S, 2010) |
| "Recent advances in the treatment of multiple myeloma have resulted in improved response rates and overall survival in patients with multiple myeloma." | 2.46 | Advances in treatment for relapses and refractory multiple myeloma. ( Richards, T; Weber, D, 2010) |
| "The treatment of multiple myeloma has undergone significant changes in the recent past." | 2.46 | Integrating novel agents into multiple myeloma treatment - current status in Switzerland and treatment recommendations. ( Bargetzi, M; Betticher, D; Gmür, J; Gregor, M; Heim, D; Hess, U; Ketterer, N; Lerch, E; Matthes, T; Mey, U; Pabst, T; Renner, C; Taverna, C, 2010) |
| "Treatment with lenalidomide was recently shown to be effective in MDS, particularly in those cases with del(5q), resulting in durable cytogenetic remission and hematological responses." | 2.44 | Evaluation of recurring cytogenetic abnormalities in the treatment of myelodysplastic syndromes. ( Le Beau, MM; Olney, HJ, 2007) |
| "For many years the treatment of multiple myeloma was limited to such regimens as melphalan-prednisone, high-dose dexamethasone, and vincristine-doxorubicin-dexamethasone (VAD)." | 2.44 | Lenalidomide in multiple myeloma. ( Richards, TA; Thomas, SK; Weber, DM, 2007) |
| "Therapeutic options for patients with multiple myeloma (MM) are rapidly changing." | 2.44 | Multiple myeloma: novel approaches for relapsed disease. ( Lonial, S, 2007) |
| "Cure for multiple myeloma is rare; the success of treatment is measured by response, and length of remissions and survival." | 2.43 | Management of multiple myeloma with bortezomib: experts review the data and debate the issues. ( Boccadoro, M; Cavenagh, J; Dicato, M; Harousseau, JL; Ludwig, H; San Miguel, J; Sonneveld, P, 2006) |
| "Relapsing patients with multiple myeloma show a response rate higher than 50% with the resumption of the initial chemotherapy." | 2.41 | Treatment approaches for relapsing and refractory multiple myeloma. ( Bladé, J; Esteve, J, 2000) |
| "Multiple myeloma is a hematologic malignancy of plasma cells that manifests with bone marrow tumors causing lytic bone lesions." | 1.91 | Revisiting checkpoint inhibitors for myeloma: maintenance after stem cell transplant. ( Bergsagel, PL; Meermeier, EW, 2023) |
| "Lenalidomide is an important medication used in induction therapy for MM and is also used for maintenance therapy for standard risk patients." | 1.72 | Three Cases of Lenalidomide Therapy for Multiple Myeloma and Subsequent Development of Secondary B-ALL. ( Asawa, P; Chahine, Z; Lister, J; Sadashiv, S; Samhouri, Y; Vusqa, UT, 2022) |
| "The treatment of multiple myeloma has dramatically improved due to the availability of novel therapies that are highly effective and are quickly moving into first-line therapy." | 1.72 | Sequential Use of Carfilzomib and Pomalidomide in Relapsed Multiple Myeloma: A Report from the Canadian Myeloma Research Group (CMRG) Database. ( Aslam, M; Gul, E; Jimenez-Zepeda, VH; Kardjadj, M; Kotb, R; LeBlanc, R; Louzada, M; Masih-Khan, E; McCurdy, A; Mian, H; Reece, D; Reiman, A; Sebag, M; Song, K; Stakiw, J; Venner, CP; White, D, 2022) |
| "Pomalidomide was given at 4 mg orally on days 1 to 21 of a 28-day cycle, and dexamethasone at 20 or 40 mg weekly." | 1.62 | Outcomes of Daratumumab, Pomalidomide, and Dexamethasone, Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation, in Patients With Relapsed/Refractory Multiple Myeloma. ( Abdallah, AO; Atrash, S; Ganguly, S; Kawsar, H; Mahmoudjafari, Z; McGuirk, J; Mohyuddin, GR; Shune, L; Sigle, M, 2021) |
| "Pomalidomide exposure was not associated with higher probabilities of treatment-emergent adverse events or pomalidomide dose interruptions during Cycle 1." | 1.62 | Recurrent or progressive pediatric brain tumors: population pharmacokinetics and exposure-response analysis of pomalidomide. ( Benettaib, B; Kassir, N; Li, Y; Ogasawara, K; Palmisano, M; Wang, X; Zhou, S, 2021) |
| "Multiple myeloma is an incurable progressive neoplastic disease that accounts for 10% of all hematologic malignancies." | 1.56 | Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel Combination Treatment of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone. ( Kassir, N; Li, Y; Palmisano, M; Wang, X; Zhou, S, 2020) |
| "Thalidomide is a medication with strong anti-inflammatory, immunomodulatory, antiangiogenic, and sedative properties." | 1.56 | Thalidomide as a potential adjuvant treatment for paraneoplastic pemphigus: A single-center experience. ( Pan, M; Wang, J; Zhang, Y, 2020) |
| "Isatuximab is used to treat multiple myeloma (MM), characterized by the excessive production of abnormal "myeloma proteins" (M-proteins) that may interact with therapeutic IgG mAb on the neonatal Fc receptor (FcRn)-mediated recycling pathway." | 1.56 | Drug-Disease Interaction and Time-Dependent Population Pharmacokinetics of Isatuximab in Relapsed/Refractory Multiple Myeloma Patients. ( Brillac, C; Campana, F; El-Cheikh, R; Fau, JB; Koiwai, K; Mace, N; Nguyen, L; Semiond, D, 2020) |
| "DLBCL rarely involves the orbit." | 1.48 | Sequential development of multifocal recurrent non-Hodgkin's lymphoma of mucosa-associated lymphoid tissue and diffuse large B-Cell lymphoma in a single patient: A case report. ( He, W; Min, X; Yang, X, 2018) |
| "An 85-year-old female was diagnosed with multiple myeloma(MM)(IgG-l)with t(4 ;14)(p16;q32)in 200X." | 1.48 | [Successful Treatment with Pomalidomide, Bortezomib, and Dexamethasone in a Patient with Frail Refractory and Relapsed Multiple Myeloma with Extramedullary Disease]. ( Nougawa, M; Oka, S; Shimazu, Y; Shiragami, H; Takeuchi, S, 2018) |
| "Multiple myeloma treatment." | 1.48 | [Multiple myeloma treatment]. ( Roussel, M; Royer, B; Talbot, A, 2018) |
| "Pomalidomide entered treatment for the second relapse in 2015 (11% of patients)." | 1.46 | Diagnosis and treatment of multiple myeloma in Germany: analysis of a nationwide multi-institutional survey. ( Goldschmidt, H; Kellermann, L; Knauf, W; Kohnke, J; Merz, M; Poenisch, W; Tischler, HJ, 2017) |
| "Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs)." | 1.46 | Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. ( Anttila, P; Bahlis, N; Biyukov, T; Cavo, M; Chen, C; Cook, G; Corradini, P; Delforge, M; Dimopoulos, MA; Hansson, M; Herring, J; Hong, K; Joao, C; Kaiser, M; Moreau, P; O'Gorman, P; Oriol, A; Raymakers, R; Richardson, PG; San-Miguel, J; Siegel, DS; Slaughter, A; Song, K; Sternas, L; Weisel, K; Yu, X; Zaki, M, 2017) |
| "Progression to multiple myeloma is the most common pattern of relapse." | 1.46 | Metachronous solitary plasmacytoma. ( Khosa, R; Nangia, S; Seth, S, 2017) |
| " LenDex was interrupted in three cases because of adverse events (infections and cutaneous events); 78 % of the patients were on thromboprophylaxis with aspirin." | 1.43 | Lenalidomide is effective and safe for the treatment of patients with relapsed multiple myeloma and very severe renal impairment. ( Coelho, I; Esteves, GV; Esteves, S; Freitas, J; Geraldes, C; Gomes, F; João, C; Lúcio, P; Neves, M, 2016) |
| "Lenalidomide at 25 mg was superior to 15 mg in terms of response (complete remission 21% and partial remission 23% vs." | 1.43 | Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Is It a Valid Treatment Option? ( Cuzzocrea, S; Ferrero, S; Ghione, P; Marabese, A; Mian, M; Mondello, P; Pitini, V; Steiner, N; Willenbacher, W, 2016) |
| "Lenalidomide is an immunomodulatory drug (IMiD) with activity in lymphoid malignancies occurring primarily through immune modulation (eg, T-cell immune synapse enhancement and NK-cell/T-cell effector augmentation) and antiproliferative effects." | 1.42 | Lenalidomide in non-Hodgkin lymphoma: biological perspectives and therapeutic opportunities. ( Coyle, M; Evens, AM; Kritharis, A; Sharma, J, 2015) |
| "Fibrolamellar variant of hepatocellular carcinoma (FLHCC) does not have a favorable prognosis than conventional HCC, and there is no difference regarding the response to chemotherapy and the degree of surgical resectability." | 1.40 | Successful multimodal treatment for aggressive metastatic and recurrent fibrolamellar hepatocellular carcinoma in a child. ( Akdemir, ÜÖ; Akyol, G; Boyunağa, Ö; Dalgiç, A; Demiroğullari, B; Eser, EP; Karadeniz, C; Oğuz, A; Okur, A; Pinarli, FG; Yilmaz, G, 2014) |
| "Relapsed/refractory multiple myeloma represents a major challenge in multiple myeloma therapy." | 1.39 | Metronomic therapy is an effective salvage treatment for heavily pre-treated relapsed/refractory multiple myeloma. ( Bailey, C; Barlogie, B; Crowley, J; Heuck, CJ; Hoering, A; Johann, D; Keller, J; Mitchell, A; Papanikolaou, X; Petty, N; Rosenthal, A; Szymonifka, J; Usmani, SZ; Van Rhee, F; Waheed, S, 2013) |
| "Advances in survival in multiple myeloma have focused payer attention on the cost of care." | 1.39 | Total cost comparison in relapsed/refractory multiple myeloma. ( Binder, G; Borrello, I; Durie, B; Hussein, M; Khan, Z; Pashos, C, 2013) |
| "Neutropenia was the main side effect of the metronomic therapy." | 1.38 | Treatment for recurrent medulloblastoma with intrathecal liposomal cytarabine and systemic metronomic combination therapy. ( Kivivuori, SM; Nygaard, R, 2012) |
| "A total of 128 cases of plasma cell leukemia were collected, and 73 of them (57%) were classified as primary (male/female 43/30)." | 1.37 | Primary plasma cell leukemia: a retrospective multicenter study of 73 patients. ( Candoni, A; De Muro, M; De Stefano, V; Ferrara, F; Fianchi, L; Galieni, P; Gozzetti, A; Leone, G; Musto, P; Pagano, L; Petrucci, MT; Pogliani, EM; Pulsoni, A; Specchia, G; Valentini, CG; Venditti, A; Visani, G; Visco, C, 2011) |
| "Recurrence of multiple myeloma (MM) after therapy suggests the presence of tumor-initiating subpopulations." | 1.37 | Lenalidomide targets clonogenic side population in multiple myeloma: pathophysiologic and clinical implications. ( Adamia, S; Anderson, KC; Blotta, S; Cervi, D; Cholujova, D; Daley, JF; Delmore, J; Jakubikova, J; Klippel, S; Kong, SY; Kost-Alimova, M; Laubach, J; Leiba, M; Mitsiades, CS; Ooi, M; Richardson, PG; Sedlak, J, 2011) |
| "The impact of cumulative dosing and premature drug discontinuation (PMDD) of bortezomib (V), thalidomide (T), and dexamethasone (D) on overall survival (OS), event-free survival (EFS), time to next therapy, and post-relapse survival in Total Therapy 3 were examined, using time-dependent methodology, relevant to induction, peritransplantation, consolidation, and maintenance phases." | 1.36 | Total Therapy 3 for multiple myeloma: prognostic implications of cumulative dosing and premature discontinuation of VTD maintenance components, bortezomib, thalidomide, and dexamethasone, relevant to all phases of therapy. ( Alsayed, Y; Anaissie, E; Barlogie, B; Crowley, J; Hoering, A; Nair, B; Petty, N; Shaughnessy, JD; Szymonifka, J; van Rhee, F; Waheed, S, 2010) |
| "Lenalidomide (25 mg daily) treatment was then initiated in a continuous dosing schedule." | 1.36 | Lenalidomide induced good clinical response in a patient with multiple relapsed and refractory Hodgkin's lymphoma. ( Kolonic, SO; Mandac, I, 2010) |
| "Epithelial ovarian cancer (EOC) recurrence is common following treatment with cytoreductive surgery and adjuvant chemotherapy." | 1.35 | Weekly topotecan and daily thalidomide in patients with recurrent epithelial ovarian cancer: a report of 2 cases. ( Leath, CA; Phippen, NT, 2009) |
| "Thalidomide is an oral immunomodulatory agent with antiangiogenic properties and activity in ovarian cancer." | 1.35 | Thalidomide-induced reversible interstitial pneumonitis in a patient with recurrent ovarian cancer. ( Buttin, BM; Moore, MJ, 2008) |
| "Lenalidomide is a novel therapeutic agent with uncertain mechanism of action that is clinically active in myelodysplastic syndrome (MDS) and multiple myeloma (MM)." | 1.35 | Higher doses of lenalidomide are associated with unacceptable toxicity including life-threatening tumor flare in patients with chronic lymphocytic leukemia. ( Andritsos, LA; Awan, F; Blum, W; Byrd, JC; Chen, CS; Jarjoura, D; Johnson, AJ; Kefauver, C; Knight, RD; Lapalombella, R; Lehman, A; Lozanski, G; May, SE; Raymond, CA; Ruppert, AS; Smith, LL; Wang, DS, 2008) |
| "Primary plasma cell leukemia (PCL) is a rare hematologic disorder with distinct features." | 1.34 | Nonsecretory primary plasma cell leukemia with good response to thalidomide-based treatment. ( Atta, J; Brück, P; Bühme, A; Hoelzer, D; Mousset, S, 2007) |
| "Thalidomide has recently shown antitumor activity in patients with refractory myeloma." | 1.31 | Thalidomide in refractory and relapsing multiple myeloma. ( Bladé, J; Esteve, J; Montoto, S; Montserrat, E; Perales, M; Rosiñol, L; Tuset, M, 2001) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 1 (0.34) | 18.2507 |
| 2000's | 62 (21.02) | 29.6817 |
| 2010's | 172 (58.31) | 24.3611 |
| 2020's | 60 (20.34) | 2.80 |
| Authors | Studies |
|---|---|
| Richardson, PG | 17 |
| Harrison, SJ | 2 |
| Bringhen, S | 6 |
| Schjesvold, F | 3 |
| Yong, K | 3 |
| Campana, F | 11 |
| Le-Guennec, S | 4 |
| Macé, S | 5 |
| Dimopoulos, MA | 16 |
| Del Giudice, ML | 1 |
| Gozzetti, A | 2 |
| Antonioli, E | 2 |
| Orciuolo, E | 1 |
| Ghio, F | 1 |
| Ciofini, S | 1 |
| Candi, V | 1 |
| Fontanelli, G | 1 |
| Attucci, I | 1 |
| Formica, G | 1 |
| Bocchia, M | 1 |
| Galimberti, S | 1 |
| Petrini, M | 1 |
| Buda, G | 1 |
| Icard, C | 1 |
| Mocquot, P | 1 |
| Nogaro, JC | 1 |
| Despas, F | 1 |
| Gauthier, M | 1 |
| Yashar, D | 1 |
| Spektor, TM | 1 |
| Martinez, D | 1 |
| Ghermezi, M | 1 |
| Swift, RA | 2 |
| Eades, B | 1 |
| Schwartz, G | 1 |
| Eshaghian, S | 1 |
| Lim, S | 1 |
| Vescio, R | 2 |
| Berenson, JR | 3 |
| Ide, T | 1 |
| Osawa, M | 1 |
| Sanghavi, K | 1 |
| Vezina, HE | 1 |
| Vusqa, UT | 1 |
| Chahine, Z | 1 |
| Asawa, P | 1 |
| Sadashiv, S | 1 |
| Samhouri, Y | 1 |
| Lister, J | 1 |
| Bahlis, NJ | 5 |
| Siegel, DS | 7 |
| Schiller, GJ | 2 |
| Samaras, C | 2 |
| Sebag, M | 3 |
| Berdeja, J | 2 |
| Ganguly, S | 3 |
| Matous, J | 3 |
| Song, K | 6 |
| Seet, CS | 2 |
| Acosta-Rivera, M | 2 |
| Bar, M | 2 |
| Quick, D | 2 |
| Anz, B | 2 |
| Fonseca, G | 2 |
| Chung, W | 4 |
| Lee, K | 2 |
| Mouro, J | 1 |
| Agarwal, A | 3 |
| Reece, D | 5 |
| Djebbari, F | 2 |
| Poynton, M | 2 |
| Sangha, G | 2 |
| Anderson, L | 2 |
| Maddams, R | 2 |
| Eyre, TA | 2 |
| Vallance, G | 2 |
| Basu, S | 3 |
| Ramasamy, K | 2 |
| McCurdy, A | 1 |
| Venner, CP | 2 |
| Masih-Khan, E | 4 |
| Louzada, M | 1 |
| LeBlanc, R | 1 |
| Jimenez-Zepeda, VH | 2 |
| Kotb, R | 1 |
| Kardjadj, M | 1 |
| Mian, H | 1 |
| White, D | 3 |
| Stakiw, J | 1 |
| Aslam, M | 1 |
| Reiman, A | 1 |
| Gul, E | 1 |
| Rachedi, F | 1 |
| Koiwai, K | 2 |
| Gaudel-Dedieu, N | 1 |
| Sebastien, B | 1 |
| Thai, HT | 1 |
| Brillac, C | 2 |
| Fau, JB | 2 |
| Nguyen, L | 2 |
| van de Velde, H | 9 |
| Veyrat-Follet, C | 1 |
| Semiond, D | 4 |
| Wang, JN | 1 |
| Liu, T | 1 |
| Zhao, AL | 1 |
| Pan, BJ | 1 |
| Sun, J | 2 |
| Li, J | 4 |
| Zhou, DB | 4 |
| Cao, XX | 1 |
| Duan, MH | 1 |
| Matsue, K | 3 |
| Sunami, K | 5 |
| Matsumoto, M | 2 |
| Kuroda, J | 1 |
| Sugiura, I | 1 |
| Iwasaki, H | 2 |
| Kuwayama, S | 1 |
| Nishio, M | 1 |
| Iida, S | 3 |
| Ikeda, T | 1 |
| Huang, SY | 2 |
| Wang, MC | 1 |
| Koh, Y | 1 |
| Min, CK | 5 |
| Yeh, SP | 1 |
| Uchiyama, M | 1 |
| Iyama, S | 1 |
| Shimazaki, C | 1 |
| Lee, JH | 5 |
| Kim, K | 8 |
| Kaneko, H | 1 |
| Kim, JS | 4 |
| Lin, TL | 1 |
| Tada, K | 1 |
| Suzuki, K | 4 |
| Rampotas, A | 1 |
| Panitsas, F | 1 |
| Basker, N | 1 |
| Salhan, B | 1 |
| Karim, F | 1 |
| Firas, AK | 1 |
| Gudger, A | 1 |
| Ngu, L | 1 |
| Lam, HPJ | 1 |
| Morgan, L | 1 |
| Yang, L | 2 |
| Young, J | 1 |
| Walker, M | 1 |
| Tsagkaraki, I | 1 |
| Chauhan, SR | 1 |
| Soutar, R | 1 |
| Triantafillou, M | 1 |
| Prideaux, S | 1 |
| Obeidalla, A | 1 |
| Bygrave, C | 1 |
| Martin, T | 3 |
| Facon, T | 11 |
| Moreau, P | 21 |
| Perrot, A | 3 |
| Spicka, I | 3 |
| Bisht, K | 1 |
| Inchauspé, M | 1 |
| Casca, F | 1 |
| He, J | 1 |
| Berringer, H | 1 |
| Heeg, B | 1 |
| Ruan, H | 1 |
| Kampfenkel, T | 2 |
| Dwarakanathan, HR | 1 |
| Johnston, S | 1 |
| Mendes, J | 1 |
| Lam, A | 1 |
| Bathija, S | 1 |
| Mackay, E | 1 |
| Husby, S | 1 |
| Bæch-Laursen, C | 1 |
| Eskelund, CW | 1 |
| Favero, F | 1 |
| Jespersen, JS | 1 |
| Hutchings, M | 1 |
| Pedersen, LB | 1 |
| Niemann, CU | 1 |
| Weischenfeldt, J | 1 |
| Räty, R | 1 |
| Larsen, TS | 1 |
| Kolstad, A | 1 |
| Jerkeman, M | 1 |
| Grønbæk, K | 1 |
| Potre, C | 1 |
| Borsi, E | 1 |
| Potre, O | 1 |
| Samfireag, M | 1 |
| Costachescu, D | 1 |
| Cerbu, B | 1 |
| Bratosin, F | 1 |
| Secosan, C | 1 |
| Negrean, RA | 1 |
| Lian, K | 3 |
| Zhang, QH | 3 |
| Hou, SL | 3 |
| Li, L | 4 |
| Zander, T | 2 |
| Pabst, T | 3 |
| Schär, S | 1 |
| Aebi, S | 1 |
| Mey, U | 2 |
| Novak, U | 2 |
| Lerch, E | 2 |
| Rhyner Agocs, G | 1 |
| Goede, J | 1 |
| Maniecka, Z | 1 |
| Hayoz, S | 1 |
| Rüfer, A | 1 |
| Renner, C | 2 |
| Driessen, C | 1 |
| Morè, S | 1 |
| Corvatta, L | 2 |
| Manieri, MV | 1 |
| Olivieri, A | 1 |
| Offidani, M | 3 |
| Costa, LJ | 2 |
| Giri, S | 1 |
| Bal, S | 1 |
| Ravi, G | 1 |
| Godby, KN | 1 |
| Meermeier, EW | 1 |
| Bergsagel, PL | 2 |
| Lu, J | 2 |
| He, HY | 1 |
| Qiang, WT | 1 |
| Liu, J | 3 |
| Guo, P | 2 |
| Jiang, H | 2 |
| Fu, WJ | 2 |
| Du, J | 2 |
| Yamaga, M | 1 |
| Katayama, S | 1 |
| Ota, M | 1 |
| Xia, Z | 1 |
| Leng, Y | 1 |
| Fang, B | 1 |
| Liang, Y | 1 |
| Li, W | 1 |
| Fu, C | 1 |
| Ke, X | 5 |
| Weng, J | 1 |
| Liu, L | 2 |
| Zhao, Y | 2 |
| Zhang, X | 5 |
| Huang, Z | 2 |
| Liu, A | 1 |
| Shi, Q | 1 |
| Gao, Y | 1 |
| Chen, X | 3 |
| Pan, L | 1 |
| Cai, Z | 4 |
| Wang, Z | 1 |
| Wang, Y | 1 |
| Fan, Y | 1 |
| Hou, M | 1 |
| Ma, Y | 3 |
| Hu, J | 2 |
| Zhou, J | 2 |
| Meng, H | 1 |
| Lu, X | 2 |
| Li, F | 1 |
| Ren, H | 1 |
| Huang, B | 1 |
| Shao, Z | 1 |
| Zhou, H | 1 |
| Hu, Y | 3 |
| Yang, S | 2 |
| Zheng, X | 1 |
| Wei, P | 1 |
| Pang, H | 1 |
| Yu, W | 1 |
| Liu, Y | 2 |
| Gao, S | 1 |
| Yan, L | 1 |
| Jing, H | 1 |
| Ling, W | 1 |
| Zhang, J | 8 |
| Sui, W | 2 |
| Wang, F | 1 |
| Li, X | 5 |
| Chen, W | 3 |
| Soekojo, CY | 1 |
| Chim, CS | 1 |
| Takezako, N | 3 |
| Asaoku, H | 1 |
| Kimura, H | 1 |
| Kosugi, H | 1 |
| Sakamoto, J | 1 |
| Gopalakrishnan, SK | 1 |
| Nagarajan, C | 1 |
| Wei, Y | 1 |
| Moorakonda, R | 1 |
| Lee, SL | 1 |
| Lee, JJ | 4 |
| Yoon, SS | 3 |
| Durie, B | 2 |
| Chng, WJ | 3 |
| Attal, M | 6 |
| Rajkumar, SV | 7 |
| San-Miguel, J | 8 |
| Beksac, M | 5 |
| Leleu, X | 9 |
| Huang, JS | 1 |
| Minarik, J | 1 |
| Cavo, M | 9 |
| Prince, HM | 2 |
| Corzo, KP | 1 |
| Dubin, F | 3 |
| Anderson, KC | 6 |
| Jung, KS | 1 |
| Kim, HJ | 2 |
| Kim, SH | 2 |
| Lee, JO | 2 |
| Eom, HS | 3 |
| Shin, HJ | 1 |
| Hawley, JE | 1 |
| Pan, S | 1 |
| Figg, WD | 3 |
| Lopez-Bujanda, ZA | 1 |
| Strope, JD | 1 |
| Aggen, DH | 1 |
| Dallos, MC | 1 |
| Lim, EA | 1 |
| Stein, MN | 1 |
| Drake, CG | 2 |
| Mouhieddine, TH | 1 |
| Barlogie, B | 7 |
| Teruya-Feldstein, J | 1 |
| White, DJ | 1 |
| Benboubker, L | 2 |
| Cook, G | 3 |
| Leiba, M | 2 |
| Ho, PJ | 1 |
| Kaufman, JL | 3 |
| Krevvata, M | 1 |
| Chiu, C | 2 |
| Qin, X | 2 |
| Okonkwo, L | 1 |
| Trivedi, S | 1 |
| Ukropec, J | 2 |
| Qi, M | 1 |
| Li, Y | 2 |
| Kassir, N | 2 |
| Wang, X | 4 |
| Palmisano, M | 2 |
| Zhou, S | 3 |
| Raab, MS | 2 |
| Engelhardt, M | 2 |
| Blank, A | 1 |
| Goldschmidt, H | 9 |
| Agis, H | 1 |
| Blau, IW | 1 |
| Einsele, H | 6 |
| Ferstl, B | 1 |
| Schub, N | 1 |
| Röllig, C | 1 |
| Weisel, K | 7 |
| Winderlich, M | 1 |
| Griese, J | 1 |
| Härtle, S | 1 |
| Weirather, J | 1 |
| Jarutat, T | 1 |
| Peschel, C | 1 |
| Chatterjee, M | 1 |
| Dimopoulos, M | 7 |
| Yagci, M | 1 |
| Larocca, A | 2 |
| Kanate, AS | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 2 Trial of the Efficacy and Safety of Elotuzumab in Combination With Pomalidomide, Carfilzomib and Dexamethasone Among High Risk Relapsed/ Refractory Multiple Myeloma Patients[NCT03104270] | Phase 2 | 13 participants (Actual) | Interventional | 2017-03-13 | Terminated (stopped due to The study was terminated early by Funding Sponsor due to low enrollment.) | ||
| A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following[NCT01946477] | Phase 2 | 186 participants (Actual) | Interventional | 2014-05-29 | Active, not recruiting | ||
| A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple[NCT02990338] | Phase 3 | 307 participants (Actual) | Interventional | 2016-12-22 | Completed | ||
| Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma[NCT02136134] | Phase 3 | 499 participants (Actual) | Interventional | 2014-08-15 | Active, not recruiting | ||
| A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.[NCT03180736] | Phase 3 | 304 participants (Actual) | Interventional | 2017-06-12 | Active, not recruiting | ||
| An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma[NCT01998971] | Phase 1 | 242 participants (Actual) | Interventional | 2014-02-18 | Active, not recruiting | ||
| Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis[NCT04943302] | Phase 2 | 0 participants (Actual) | Interventional | 2022-09-30 | Withdrawn (stopped due to PI left institution. Study not moving forward in her absence.) | ||
| GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D[NCT05558319] | Phase 3 | 480 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting | ||
| A Phase 2 Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma Patients With t(11;14)[NCT06115135] | Phase 2 | 39 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting | ||
| A Double Blinded Randomized Crossover Phase III Study of Oral Thalidomide Versus Placebo in Patients With Stage D0 Androgen Dependent Prostate Cancer Following Limited Hormonal Ablation[NCT00004635] | Phase 3 | 159 participants (Actual) | Interventional | 2000-03-01 | Completed | ||
| Multicenter, Phase II, National and Open-label Study to Evaluate Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.[NCT05527340] | Phase 2 | 140 participants (Anticipated) | Interventional | 2022-09-30 | Not yet recruiting | ||
| A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple My[NCT01421186] | Phase 1/Phase 2 | 91 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
| Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection - A Phase 2 Pilot Trial[NCT05021484] | Phase 2 | 22 participants (Actual) | Interventional | 2021-10-06 | Active, not recruiting | ||
| Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients[NCT02384083] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
| A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies[NCT01084252] | Phase 1/Phase 2 | 351 participants (Actual) | Interventional | 2010-06-10 | Completed | ||
| A Phase 1b Study of SAR650984 (Isatuximab) in Combination With Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma[NCT02283775] | Phase 1 | 54 participants (Actual) | Interventional | 2015-05-15 | Completed | ||
| A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma[NCT01080391] | Phase 3 | 792 participants (Actual) | Interventional | 2010-07-14 | Completed | ||
| A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma[NCT01749969] | Phase 1 | 57 participants (Actual) | Interventional | 2013-02-06 | Completed | ||
| A Non-interventional Post Authorisation Registry of Patients Treated With Pomalidomide for Relapsed and Refractory Multiple Myeloma Who Have Received at Least Two Prior Treatment Regimens, Including Both Lenalidomide and Bortezomib, and Have Demonstrated [NCT02164955] | 775 participants (Actual) | Observational [Patient Registry] | 2014-06-26 | Completed | |||
| A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma[NCT01712789] | Phase 3 | 682 participants (Actual) | Interventional | 2012-11-06 | Completed | ||
| A Phase 1, Multicenter, Open Label, Dose-escalation Study to Determine the Maximum Tolerated Dose for the Combination of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LDDEX) in Subjects With Relapsed or Refractory Multiple Myeloma (MM)[NCT01497093] | Phase 1 | 34 participants (Actual) | Interventional | 2012-02-15 | Completed | ||
| A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma[NCT01460940] | Phase 2 | 24 participants (Actual) | Interventional | 2011-10-13 | Completed | ||
| A Multi-Center Phase 2 Study of Daratumumab With Pomalidomide and Dexamethasone in Combination With All-Transretinoic Acid in Patients With Multiple Myeloma Previously Exposed to Daratumumab-Based Regimens[NCT04700176] | Phase 2 | 43 participants (Anticipated) | Interventional | 2022-05-02 | Recruiting | ||
| A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma[NCT05199311] | Phase 1/Phase 2 | 66 participants (Anticipated) | Interventional | 2022-05-13 | Recruiting | ||
| A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma[NCT01564537] | Phase 3 | 722 participants (Actual) | Interventional | 2012-08-01 | Completed | ||
| A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)[NCT01145495] | Phase 2 | 66 participants (Actual) | Interventional | 2010-06-15 | Completed | ||
| A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma[NCT01568866] | Phase 3 | 929 participants (Actual) | Interventional | 2012-06-20 | Completed | ||
| Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma[NCT01722305] | Phase 1 | 29 participants (Actual) | Interventional | 2013-04-08 | Completed | ||
| A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects[NCT01707407] | Phase 1 | 32 participants (Actual) | Interventional | 2012-09-01 | Completed | ||
| Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice[NCT02902900] | 2,504 participants (Actual) | Observational | 2015-04-01 | Completed | |||
| A Phase 1, Multicenter, Open-label, Dose-escalation Study in Japan to Determine the Tolerated Dose and to Evaluate the Safety, Efficacy, and Pharmacokinetics of Pomalidomide Alone or in Combination With Dexamethasone in Patients With Refractory or Relapse[NCT01568294] | Phase 1 | 12 participants (Actual) | Interventional | 2012-04-01 | Completed | ||
| A Phase II Study of Dexamethasone (DECADRON®), Clarithromycin (BIAXIN®), and Pomalidomide (CC-4047®) for Subjects With Relapsed or Refractory Multiple Myeloma[NCT01159574] | Phase 2 | 121 participants (Actual) | Interventional | 2010-08-31 | Completed | ||
| A Multi-center, Open-label Extended Access Program of Lenalidomide Plus Low-dose Dexamethasone in Chinese Subjects With Relapsed/Refactory Multiple Myeloma Who Participated in Study CC-5013-MM-021 for at Least One Year.[NCT02348528] | Phase 2 | 65 participants (Actual) | Interventional | 2012-09-11 | Completed | ||
| Phase 1b Multicenter Dose Escalation Study of Carfilzomib With Lenalidomide and Dexamethasone for Safety and Activity in Relapsed Multiple Myeloma[NCT00603447] | Phase 1 | 84 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| A Phase II Study Incorporating Bone Marrow Microenvironment (ME) - Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DTPACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance[NCT00572169] | Phase 3 | 177 participants (Actual) | Interventional | 2006-11-30 | Active, not recruiting | ||
| A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance[NCT00081939] | Phase 2 | 303 participants (Actual) | Interventional | 2004-01-31 | Completed | ||
| A Prospective, Multicenter, Single Arm, Phase II Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone (BiRd Regimen) in the Treatment of the First Relapsed Multiple Myeloma[NCT04063189] | Phase 2 | 100 participants (Anticipated) | Interventional | 2017-03-21 | Recruiting | ||
| A Multi-center, Open-Label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma[NCT01593410] | Phase 2 | 194 participants (Actual) | Interventional | 2010-08-01 | Completed | ||
| Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans[NCT00200681] | Phase 3 | 493 participants (Actual) | Interventional | 2005-06-30 | Completed | ||
| A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autolo[NCT00461747] | Phase 3 | 390 participants (Anticipated) | Interventional | 2006-03-31 | Completed | ||
| A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation[NCT01134484] | Phase 3 | 480 participants (Actual) | Interventional | 2006-05-31 | Active, not recruiting | ||
| A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma[NCT01311687] | Phase 3 | 455 participants (Actual) | Interventional | 2011-03-11 | Completed | ||
| A Phase 1, Multicenter, Open-label, Dose-Escalation Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma[NCT02103335] | Phase 1 | 38 participants (Actual) | Interventional | 2014-06-05 | Completed | ||
| Multicenter Study of Pomalidomide, Cyclophosphamide, and Dexamethasone in Relapsed Refractory Myeloma: Safety Profile in Mexican Population[NCT03601624] | Phase 2 | 18 participants (Anticipated) | Interventional | 2018-09-01 | Recruiting | ||
| [NCT03023527] | Phase 1 | 6 participants (Actual) | Interventional | 2017-01-31 | Terminated (stopped due to Safety) | ||
| Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003[NCT01324947] | Phase 3 | 74 participants (Actual) | Interventional | 2011-03-01 | Completed | ||
| Randomized Phase 3 Study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory Myeloma. An AMN Study[NCT03143049] | Phase 3 | 120 participants (Anticipated) | Interventional | 2017-09-13 | Recruiting | ||
| A Phase 1/2 Open Label Study of SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma[NCT02661022] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2016-01-31 | Terminated | ||
| A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma[NCT00413036] | Phase 2 | 217 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)[NCT02446236] | Phase 1 | 27 participants (Actual) | Interventional | 2015-06-18 | Active, not recruiting | ||
| Anti-Angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen (Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients With Relapsed or Progressive Cancer[NCT00357500] | Phase 2 | 101 participants (Actual) | Interventional | 2005-01-31 | Completed | ||
| A Phase I/II Multicenter, Randomized, Open Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Safety, And Efficacy Of CC-4047 Alone Or In Combination With Low-Dose Dexamethasone In Patients Wth Relapsed And Refractory Multiple Myeloma W[NCT00833833] | Phase 1/Phase 2 | 259 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| Carfilzomib and Dexamethasone in Combination With Cyclophosphamide vs. Carfilzomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma: a Phase II Randomized Controlled Trial[NCT03336073] | Phase 2 | 199 participants (Actual) | Interventional | 2017-12-18 | Active, not recruiting | ||
| A Two Stage Trial of lénalidomide (Revlimid®) : a Phase II Study of lénalidomide as Single Agent in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse: Followed by a Phase I of lénalidomide in Combination With Carboplatin and Lipo[NCT01111903] | Phase 1/Phase 2 | 67 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma[NCT00322985] | Phase 2 | 40 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.[NCT03964480] | 1,000 participants (Anticipated) | Observational [Patient Registry] | 2018-10-14 | Recruiting | |||
| A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy in Subjects With Previously Untreated Follicular Lymphoma[NCT01476787] | Phase 3 | 255 participants (Actual) | Interventional | 2011-12-29 | Active, not recruiting | ||
| A Phase II Study of Revlimid in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL)[NCT00695786] | Phase 2 | 156 participants (Actual) | Interventional | 2008-06-10 | Completed | ||
| A Multicenter Open Label Phase II Study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma Patients With Deletion 17p or Translocation (4;14) Adverse Karyotypic Abnormalities-IFM2010-02[NCT01745640] | Phase 2 | 63 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| Clinical and Pharmacodynamic Comparison of Continuous Versus Intermittent Dosing Regimens for Pomalidomide in Relapsed/Refractory Multiple Myeloma[NCT01319422] | Phase 2 | 40 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse[NCT01217203] | Phase 1 | 15 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory[NCT00238238] | Phase 2 | 97 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
| Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone (R2-GOD) in Treatment of Relapse/Refractory DLBCL:A Phase I Study[NCT03795571] | Phase 1 | 12 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting | ||
| A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma[NCT00875667] | Phase 2 | 254 participants (Actual) | Interventional | 2009-04-30 | Completed | ||
| A Phase II Trial to Evaluate the Safety and Activity of Single-agent Lenalidomide Given as Maintenance Therapy After Response to Second-line Therapy in Patients With Relapsed DLBCL, Not Eligible for High-dose Chemotherapy and ASCT[NCT00799513] | Phase 2 | 47 participants (Anticipated) | Interventional | 2009-10-31 | Recruiting | ||
| A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) In Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma[NCT00179660] | Phase 2 | 50 participants (Actual) | Interventional | 2005-08-31 | Completed | ||
| A Phase II Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma[NCT01466868] | Phase 2 | 22 participants (Actual) | Interventional | 2011-11-30 | Terminated (stopped due to Regarding the comments of the iDSMB, the sponsor decided to stop the inclusions) | ||
| A Multicenter Phase I/II Trial Evaluating the Safety and Efficacy of Lenalidomide (Revlimid, CC-5013) in Combination With Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma[NCT00306813] | Phase 1/Phase 2 | 53 participants (Anticipated) | Interventional | 2004-09-30 | Completed | ||
| An Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis.[NCT01510613] | Phase 2 | 28 participants (Actual) | Interventional | 2012-02-29 | Completed | ||
| Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma[NCT00507442] | Phase 1/Phase 2 | 158 participants (Actual) | Interventional | 2007-08-31 | Completed | ||
| The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.[NCT00424047] | Phase 3 | 351 participants (Actual) | Interventional | 2003-01-01 | Completed | ||
| A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma[NCT00056160] | Phase 3 | 353 participants (Actual) | Interventional | 2003-01-01 | Completed | ||
| National, Open-label, Multicentre Phase I-II Study of Combination R-ESHAP With Lenalidomide as Salvage Therapy for Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma Candidates to Stem-cell Transplantation[NCT02340936] | Phase 1/Phase 2 | 53 participants (Actual) | Interventional | 2011-01-31 | Completed | ||
| Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma[NCT00452569] | Phase 3 | 499 participants (Actual) | Interventional | 2006-02-01 | Completed | ||
| A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide (DVD-R) for Patients With Relapsed/Refractory Multiple Myeloma[NCT01160484] | Phase 2 | 40 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| (PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older[NCT01453088] | Phase 2 | 63 participants (Actual) | Interventional | 2010-06-24 | Terminated (stopped due to Lack of Accrual) | ||
| Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma[NCT01241708] | Phase 3 | 146 participants (Actual) | Interventional | 2010-04-08 | Completed | ||
| Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme[NCT00006358] | Phase 2 | 44 participants (Actual) | Interventional | 2000-06-13 | Completed | ||
| A Two-Arm, Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)[NCT00628238] | Phase 2 | 80 participants (Anticipated) | Interventional | 2008-02-29 | Recruiting | ||
| Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated CLL With Four or Six Cycles of Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide Followed by Lenalidomide Consolidation/ Maintenance[NCT01723839] | Phase 2 | 21 participants (Actual) | Interventional | 2012-02-22 | Completed | ||
| Phase 2 Trial of Lenalidomide (Revlimid)-Dexamethasone + Rituximab in Recurrent Small B-Cell Non-Hodgkin Lymphomas (NHL) Resistant to Rituximab[NCT00783367] | Phase 2 | 50 participants (Actual) | Interventional | 2008-07-31 | Completed | ||
| A Phase I/II Study of Combination Dasatinib and Lenalidomide in Purine Analogue-Failed Chronic Lymphocytic Leukemia[NCT00829647] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2009-01-31 | Withdrawn (stopped due to Unable to enroll) | ||
| A Phase I/II Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, (BdL) for the Treatment of Patients With Relapsed Myeloma.[NCT01686386] | Phase 1/Phase 2 | 60 participants (Anticipated) | Interventional | 2010-02-28 | Recruiting | ||
| [NCT02748772] | Phase 3 | 148 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting | ||
| A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas[NCT00036894] | Phase 1 | 0 participants | Interventional | 2002-03-31 | Completed | ||
| A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma[NCT00103506] | Phase 3 | 646 participants (Actual) | Interventional | 2004-12-31 | Completed | ||
| A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders[NCT01832597] | 109 participants (Actual) | Observational | 2010-11-30 | Completed | |||
| Lenalidomide (Revlimid) in Patients With Previously Treated Chronic Lymphocytic Leukemia[NCT00267059] | Phase 2 | 45 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas[NCT00047879] | Phase 2 | 7 participants (Actual) | Interventional | 2002-10-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as >= 25% but <= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, >=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. (NCT02990338)
Timeframe: From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 46.4 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 66.9 |
DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL;urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion,or >=50% increase in the longest diameter of a previous lesion >1 cm in short axis. PR:>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h. (NCT02990338)
Timeframe: From the date of the first IRC determined response to the date of first IRC progression or death, whichever occurred first (maximum duration 76.7 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 11.07 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 13.27 |
ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h,if present at baseline,>=50% reduction in the size (SPD) of soft tissue plasmacytomas. (NCT02990338)
Timeframe: From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 35.3 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 60.4 |
OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met. (NCT02990338)
Timeframe: From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 17.71 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 24.57 |
VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h or >=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates. (NCT02990338)
Timeframe: From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 8.5 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 31.8 |
PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of >=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >=0.5gram(g)/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24hour), appearance of new lesion(s),>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis. (NCT02990338)
Timeframe: From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 6.47 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 11.53 |
PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1 g/dL if lowest M component was >=5 g/dL; urine M-component (absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 centimeter (cm) in short axis. (NCT02990338)
Timeframe: From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 3.745 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 7.491 |
TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. (NCT02990338)
Timeframe: From the date of randomization to date of first occurrence of IRC determined best overall response or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 5.06 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 4.30 |
TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. (NCT02990338)
Timeframe: From the date of randomization to the date of first IRC determined response, or death or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 3.02 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 1.94 |
TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of >= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >= 0.5 g/dL), serum M-protein increase >=1 g/dL if the lowest M component was >=5 g/dL; urine M-component (the absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis. (NCT02990338)
Timeframe: From the date of randomization to the date of first documentation of progression, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | months (Median) |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 7.75 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 12.71 |
EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant. (NCT02990338)
Timeframe: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1: Cycle 3 | Day 1: Cycle 6 | Day 1: Cycle 9 | Day 1: Cycle 17 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 60.10 | -1.22 | -0.16 | 0.41 | -1.92 |
| Pd (Pomalidomide + Dexamethasone) | 61.19 | -1.45 | -0.12 | 1.06 | -9.17 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL (NCT02990338)
Timeframe: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1: Cycle 3 | Day 1: Cycle 6 | Day 1: Cycle 9 | Day 1: Cycle 17 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 24.12 | -2.07 | -3.30 | -4.66 | 0.00 |
| Pd (Pomalidomide + Dexamethasone) | 24.91 | -3.79 | -4.08 | -2.83 | -3.33 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL. (NCT02990338)
Timeframe: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1: Cycle 3 | Day 1: Cycle 6 | Day 1: Cycle 9 | Day 1: Cycle 17 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 15.60 | 2.61 | 2.11 | 3.14 | 3.02 |
| Pd (Pomalidomide + Dexamethasone) | 17.49 | 1.69 | -0.13 | 1.43 | -2.93 |
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. (NCT02990338)
Timeframe: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1: Cycle 3 | Day 1: Cycle 6 | Day 1: Cycle 9 | Day 1: Cycle 17 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0.71 | -0.01 | -0.00 | -0.01 | -0.01 |
| Pd (Pomalidomide + Dexamethasone) | 0.70 | -0.01 | 0.02 | -0.03 | -0.02 |
EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. (NCT02990338)
Timeframe: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
| Intervention | centimeter (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1: Cycle 3 | Day 1: Cycle 6 | Day 1: Cycle 9 | Day 1: Cycle 17 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 66.62 | 0.92 | 1.19 | 1.96 | -3.00 |
| Pd (Pomalidomide + Dexamethasone) | 65.38 | 0.26 | 2.49 | 4.42 | -1.70 |
ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment. (NCT02990338)
Timeframe: From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Pre-existing ADA | Treatment induced ADA | Treatment boosted ADA | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0 | 0 | 0 |
MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. (NCT02990338)
Timeframe: Up to 76.7 weeks
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| MRD negative:1 in 10^4 | MRD negative:1 in 10^5 | MRD negative:1 in 10^6 | MRD positive:1 in 10^4 | MRD positive:1 in 10^5 | MRD positive:1 in 10^6 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 10 | 8 | 2 | 4 | 6 | 9 |
| Pd (Pomalidomide + Dexamethasone) | 0 | 0 | 0 | 2 | 2 | 2 |
Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. (NCT02990338)
Timeframe: From randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any TEAE | Any treatment emergent SAE | Any TEAE leading to treatment discontinuation | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 151 | 112 | 19 |
| Pd (Pomalidomide + Dexamethasone) | 146 | 91 | 22 |
BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h. MR:>=25% but <=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD. (NCT02990338)
Timeframe: From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Stringent complete response | Complete response | Very good partial response | Partial response | Minimal response | Stable disease | Progressive Disease | Not evaluable | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0 | 4.5 | 27.3 | 28.6 | 6.5 | 21.4 | 3.9 | 4.5 |
| Pd (Pomalidomide + Dexamethasone) | 0.7 | 1.3 | 6.5 | 26.8 | 11.1 | 29.4 | 9.2 | 10.5 |
Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion. (NCT02990338)
Timeframe: End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1
| Intervention | ratio (Geometric Mean) | |
|---|---|---|
| C2D1 versus C1D1 | C4D1 versus C1D1 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 1.860 | 1.777 |
CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion. (NCT02990338)
Timeframe: Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1
| Intervention | mcg/mL (Geometric Mean) | |
|---|---|---|
| C1D1 | C4D1 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 171.55 | 294.96 |
CEOI was defined as the plasma concentration at end of infusion. (NCT02990338)
Timeframe: End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1
| Intervention | microgram per milliliter (mcg/mL) (Geometric Mean) | |||
|---|---|---|---|---|
| End of infusion: C1D1 | End of infusion: C1D15 | End of infusion: C2D1 | End of infusion: C4D1 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 163.05 | 269.20 | 299.85 | 279.31 |
Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration. (NCT02990338)
Timeframe: Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1
| Intervention | ratio (Geometric Mean) | |
|---|---|---|
| C2D1 versus C1D8 | C4D1 versus C1D8 | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 2.689 | 2.620 |
Trough Concentration (Ctrough) is the concentration prior to study drug administration. (NCT02990338)
Timeframe: Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT [30 days after last drug administration])
| Intervention | mcg/mL (Geometric Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1D1 | C1D8 | C1D15 | C1D22 | C2D1 | C2D15 | C3D1 | C3D15 | C4D1 | C4D15 | C5D1 | C6D1 | C7D1 | C8D1 | C9D1 | C10D1 | C11D1 | C12D1 | C13D1 | C14D1 | C15D1 | C16D1 | C17D1 | C18D1 | C19D1 | C20D1 | EOT | |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0.00 | 31.49 | 57.89 | 84.82 | 89.09 | 89.35 | 64.15 | 91.73 | 86.05 | 105.42 | 106.08 | 111.33 | 134.14 | 146.15 | 162.84 | 145.86 | 169.39 | 182.32 | 215.85 | 214.88 | 253.61 | 206.60 | 242.79 | 216.70 | 240.36 | 164.07 | 9.51 |
The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT02136134)
Timeframe: Up to disease progression (approximately of 3 years)
| Intervention | percentage of participants (Number) |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 63.2 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 82.9 |
Overall Survival was measured from the date of randomization to the date of the participant's death. (NCT02136134)
Timeframe: Up to the end of the study (approximately of 3 years)
| Intervention | months (Median) |
|---|---|
| Bortezomib + Dexamethasone (Vd) | NA |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | NA |
Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry. (NCT02136134)
Timeframe: Up to disease progression (approximately of 3 years)
| Intervention | percentage of participants (Number) |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 29.1 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 59.2 |
The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry. (NCT02136134)
Timeframe: Up to disease progression (approximately of 3 years)
| Intervention | percentage of participants (Number) |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 2.8 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | 13.5 |
PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. (NCT02136134)
Timeframe: From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years)
| Intervention | months (Median) |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 7.16 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | NA |
TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder. (NCT02136134)
Timeframe: From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years)
| Intervention | months (Median) |
|---|---|
| Bortezomib + Dexamethasone (Vd) | 7.29 |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | NA |
Comparison of Progression Free Survival between treatment arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone)[ Time Frame: Assessed monthly from randomization until disease progression (PD) or death whichever occurs first (approximately up to 3 years)] Progression free survival is defined as the time, in months, from randomization to the date of the first documented PD or death due to any cause, whichever comes first. PD will be assessed by the investigator based on the analysis of serum and urine protein electrophoresis (sPEP and uPEP), serum and urine immunofixation (sIFE and uIFE), serum free light chain protein (sFLC),corrected serum calcium assessment, imaging and bone marrow assessments as per modified IMWG guidelines. (NCT03180736)
Timeframe: Assessed monthly from randomization until disease progression (PD) or death whichever occurs first (approximately up to 3 years)]
| Intervention | months (Median) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 12.42 |
| Pomalidomide + Dexamethasone | 6.93 |
To assess the depth of response by analyzing the percentage of patients with Minimal Residual Disease (MRD) negativity (<10-5), considering the patients who have achieved CR or better, and patients with suspected CR/sCR. (NCT03180736)
Timeframe: From randomization to disease progression or subsequent antimyeloma therapy, assessed up to approximately 3 years.
| Intervention | percentage of participants (Number) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 8.61 |
| Pomalidomide + Dexamethasone | 1.96 |
Duration of response will be restricted to the randomized subjects who achieve a best objective response of PR or better. It is measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS). (NCT03180736)
Timeframe: From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.
| Intervention | months (Median) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | NA |
| Pomalidomide + Dexamethasone | 15.90 |
Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups. (NCT03180736)
Timeframe: Day 1 of each treatment cycle, at end of treatment, and every 4 weeks post treatment until PD (approximately up to 3 years)
| Intervention | months (Median) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 4.01 |
| Pomalidomide + Dexamethasone | 3.84 |
"Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups.~The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating health today" (NCT03180736)
Timeframe: Day 1 of each treatment cycle, at end of treatment, and every 4 weeks post treatment until PD (approximately up to 3 years)
| Intervention | months (Mean) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 7.39 |
| Pomalidomide + Dexamethasone | 6.14 |
"Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups.~The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating health today" (NCT03180736)
Timeframe: Day 1 of each treatment cycle, at end of treatment, and every 4 weeks post treatment until PD (approximately up to 3 years)
| Intervention | months (Mean) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 3.78 |
| Pomalidomide + Dexamethasone | 2.86 |
Overall response rate is defined as the percentage of randomized subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response (NCT03180736)
Timeframe: Assessed monthly from Randomization until PD, (approximately up to 3 years)]
| Intervention | percentage of participants (Number) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 68.87 |
| Pomalidomide + Dexamethasone | 46.41 |
Time to next therapy will be defined as the time, in months, from randomization to the date to next anti-neoplastic therapy or death from any cause, whichever comes first. (NCT03180736)
Timeframe: From randomization until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 3 years)
| Intervention | months (Median) |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 23.23 |
| Pomalidomide + Dexamethasone | 11.83 |
Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00004635)
Timeframe: Date treatment consent signed to date off study, approximately 60 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Thalidomide | 117 |
| Placebo | 98 |
Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml. (NCT00004635)
Timeframe: 36 months
| Intervention | months (Median) |
|---|---|
| Thalidomide | 15 |
| Placebo | 9.6 |
"as monotherapy~in combination with dexamethasone~in combination with pomalidomide + dexamethasone~in combination with lenalidomide + dexamethasone" (NCT01421186)
Timeframe: First cycle of treatment
| Intervention | mg/kg (Number) |
|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 16 |
| Part B: MOR03087 Weekly Dose Escalation | 16 |
| Part C: MOR03087 Plus Dexamethasone | 16 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 16 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 16 |
Duration of response (Kaplan Meier estimates) (NCT01421186)
Timeframe: patients were observed up to 36 months
| Intervention | months (Median) |
|---|---|
| Part C: MOR03087 Plus Dexamethasone | 16.7 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 21.2 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 32.2 |
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity (NCT01421186)
Timeframe: during treatment period, maximum 3 years after 1st dose
| Intervention | Participants (Count of Participants) |
|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 0 |
| Part B: MOR03087 Weekly Dose Escalation | 0 |
| Part C: MOR03087 Plus Dexamethasone | 0 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 0 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 0 |
number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response) (NCT01421186)
Timeframe: maximum 3 years after 1st dose
| Intervention | Participants (Count of Participants) |
|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 0 |
| Part B: MOR03087 Weekly Dose Escalation | 0 |
| Part C: MOR03087 Plus Dexamethasone | 5 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 10 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 11 |
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups (NCT01421186)
Timeframe: 56 days
| Intervention | mg*days/L (Mean) |
|---|---|
| 4 mg/kg QW | 3307.57 |
| 8 mg/kg QW | 7970.15 |
| 16 mg/kg QW | 18178.57 |
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups (NCT01421186)
Timeframe: up to 7 days after last MOR202 dose
| Intervention | µg/mL (Mean) |
|---|---|
| 4 mg/kg QW | 137.86 |
| 8 mg/kg QW | 311.67 |
| 16 mg/kg QW | 681.53 |
Progression-free survival (Kaplan Meier estimates) (NCT01421186)
Timeframe: patients were observed up to 36 months
| Intervention | months (Median) |
|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 1.1 |
| Part B: MOR03087 Weekly Dose Escalation | 2.1 |
| Part C: MOR03087 Plus Dexamethasone | 8.4 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 15.9 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 26.7 |
Time to Progression (Kaplan Meier estimate) (NCT01421186)
Timeframe: patients were observed for up to 36 months
| Intervention | months (Median) |
|---|---|
| Part A: MOR03087 Biweekly Dose Escalation | 1.1 |
| Part B: MOR03087 Weekly Dose Escalation | 2.1 |
| Part C: MOR03087 Plus Dexamethasone | 8.4 |
| Part D: MOR03087 Plus Pomalidomide + Dexamethasone | 15.9 |
| Part E: MOR03087 Plus Lenalidomide + Dexamethasone | 33.2 |
DOR: time from first response (PR or better) to first documented tumor progression/death. Progression as per EBMT: >25% increase in serum monoclonal paraprotein level, which must also be an absolute increase of >= 5 g/l: confirmed by >=1 repeated investigation; >25% increase in 24h urinary light chain excretion, which must also be an absolute increase of >=200 mg/24 h:confirmed by >=1 repeated investigation; >25% increase in plasma cells in a bone marrow aspirate/on trephine biopsy, which must also be an absolute increase of >= 10%; definite increase in size of existing bone lesions/soft tissue plasmacytomas; development of new bone lesions/soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11·5 mg/dl or 2·8 mmol/l) not attributable to any other cause. PR: >=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size/number of lytic bone lesions. (NCT01084252)
Timeframe: From the date of first response to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
| Intervention | months (Mean) |
|---|---|
| Phase 1: Isatuximab 1mg/kg Q2W | 20.21 |
| Phase 1: Isatuximab 5mg/kg Q2W | 7.16 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 5.76 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 10.70 |
| Phase 1: Isatuximab 10mg/kg QW | 14.31 |
| Phase 1: Isatuximab 20mg/kg Q2W | 3.94 |
| Phase 1: Isatuximab 20mg/kg QW | 8.82 |
TTR was defined as the time from first dose of isatuximab to first response (PR or better). PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. (NCT01084252)
Timeframe: From the date of first dose administration to the date of first response or death (due to any cause) (maximum duration: 120 weeks)
| Intervention | months (Mean) |
|---|---|
| Phase 1: Isatuximab 1mg/kg Q2W | 0.95 |
| Phase 1: Isatuximab 5mg/kg Q2W | 6.41 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 2.52 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 1.96 |
| Phase 1: Isatuximab 10mg/kg QW | 1.38 |
| Phase 1: Isatuximab 20mg/kg Q2W | 1.18 |
| Phase 1: Isatuximab 20mg/kg QW | 1.46 |
(NCT01084252)
Timeframe: Pre-dose, at the end of infusion, 1 hour and 168 hours post dose on Day 1 of Cycle 1
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 37096 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 35423 |
(NCT01084252)
Timeframe: Cycle 1, Day 1: pre-dose, at the end of infusion, 168 and 336 hours post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 91271 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 86761 |
(NCT01084252)
Timeframe: Cycle 1, Day 1: pre-dose, at the end of infusion, 168, 336, and 672 hours post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 236360 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 226372 |
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT. (NCT01084252)
Timeframe: Day 1 of Cycle 1 up to Day 14 of Cycle 2
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 1:Isatuximab <=1 mg/kg Q2W | 1 |
| Phase 1: Isatuximab 3mg/kg Q2W | 1 |
| Phase 1: Isatuximab 5mg/kg Q2W | 0 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 0 |
| Phase 1: Isatuximab 10 mg/kg QW | 0 |
| Phase 1: Isatuximab 20mg/kg Q2W | 0 |
| Phase 1: Isatuximab 20mg/kg QW | 0 |
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 1: Isatuximab <=1mg/kg Q2W | 16 |
| Phase 1: Isatuximab 3mg/kg Q2W | 6 |
| Phase 1: Isatuximab 5mg/kg Q2W | 3 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 26 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 18 |
| Phase 1: Isatuximab 10 mg/kg QW | 6 |
| Phase 1: Isatuximab 20mg/kg Q2W | 7 |
| Phase 1: Isatuximab 20mg/kg QW | 6 |
DOR:Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of first IAC determined PD/death, whichever happened earlier. updated IMWG criteria- PR:>=50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a >=50% reduction in size of soft tissue plasmacytomas; PD: Increase of 25% from lowest response value in any of following: Serum M-protein >=0.5 g/dL absolute increase and/or urine M-protein >=200 mg/24 hours absolute increase and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cells (PCs), development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium >11·5 mg/dl) attributed to PC proliferation disorder. (NCT01084252)
Timeframe: From the date of first response until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | months (Mean) |
|---|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 1.91 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 11.17 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 7.31 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 8.11 |
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 22 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 24 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 25 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 25 |
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of randomization to date of death from any cause (maximum duration 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | months (Median) |
|---|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 15.277 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 18.628 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | NA |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | NA |
Clinical benefit: participants with sCR, CR, VGPR, PR or MR as per IMWG criteria, determined by IAC. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% PCs in bone marrow aspirates. sCR: CR + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours, ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline, ≥50% size reduction in soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein, reduction in 24h urine M-protein by 50-89%, 25-49% size reduction in soft tissue plasmacytomas. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | percentage of participants (Number) |
|---|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 4.3 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 41.7 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 32.0 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 36.0 |
OR defined as participants with stringent complete response (sCR) or complete response (CR) or very good partial response (VGPR) or partial response (PR) . Based on IMWG, CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if present at baseline. (NCT01084252)
Timeframe: From the date of randomization until disease progression or death or data cut-off (maximum duration: 77 weeks )
| Intervention | percentage of participants (Number) |
|---|---|
| Phase 2 Stage 1a: Isatuximab 3 mg/kg | 4.3 |
| Phase 2 Stage 1a: Isatuximab 10 mg/kg | 29.2 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W and Then Q4W | 20.0 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 24.0 |
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression (PD) or date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h), > 10mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, >10% absolute percentage of bone marrow plasma cell, definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | months (Median) |
|---|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 2.1 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 9.6 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 4.4 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 3.6 |
DOR: Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of 1st IAC determined PD or death, whichever happened earlier. As per updated IMWG criteria-PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. ≥50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline ≥50% reduction in size of soft tissue plasmacytomas; PD: Increase of >25% from lowest response value in any one of following: Serum M-component (absolute increase must be >0.5 g/dL)4 and/or Urine M-component (absolute increase must be >200 mg/24 h) and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell proliferative disorder. (NCT01084252)
Timeframe: From the date of first response until disease progression or death or data cut-off (maximum duration: 97 weeks)
| Intervention | months (Mean) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 8.6 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 10.9 |
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 97 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 100 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 51 |
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
| Intervention | months (Median) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 18.92 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 17.25 |
Clinical benefit:participants with sCR, CR, VGPR, PR or MR, per IMWG criteria, determined by IAC. CR:negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates,normal FLC ratio(0.26-1.65) in participants with only FLC disease.sCR:CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy.VGPR:serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24h/,>=90% decrease in difference between involved and uninvolved FLC levels; PR:>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90%/<200mg/24h,>50% decrease in difference between involved and uninvolved FLC in place of M-protein criteria, >=50% reduction in size/number of soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein,reduction in 24h urine M-protein by 50-89%, 25-49% reduction in size of soft tissue plasmacytomas (NCT01084252)
Timeframe: From the date of randomization to the date of first documentation of progression or death (maximum duration: 97 weeks )
| Intervention | percentage of participants (Number) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 43.1 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 54.5 |
OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours, >90% decrease in the difference between involved and uninvolved FLC levels; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or >=50% reduction in plasma cells in place of M-protein if present at baseline. (NCT01084252)
Timeframe: From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 23.9 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 43.6 |
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression or the date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of >25% from lowest response value in any one of the following: Serum M-component (the absolute increase must be >0.5 g/dL)4 and/or Urine M-component (the absolute increase must be >200 mg/24 h) and/or >10 mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, ≥10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 97 weeks)
| Intervention | months (Median) |
|---|---|
| Phase 2 Stage 2: Isatuximab Alone | 4.86 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 10.15 |
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 336 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 336 hr post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|---|
| Phase 1: Isatuximab 1 mg/kg Q2W | 222 |
| Phase 1: Isatuximab 3mg/kg Q2W | 3076 |
| Phase 1: Isatuximab 5mg/kg Q2W | 9546 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 14876 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 18967 |
| Phase 1: Isatuximab 10mg/kg QW | 30187 |
| Phase 1: Isatuximab 20mg/kg Q2W | 48003 |
| Phase 1: Isatuximab 20mg/kg QW | 71174 |
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|---|
| Phase 1: Isatuximab 1 mg/kg Q2W | 222 |
| Phase 1: Isatuximab 3mg/kg Q2W | 2624 |
| Phase 1: Isatuximab 5mg/kg Q2W | 7174 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 11566 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 13480 |
| Phase 1: Isatuximab 10mg/kg QW | 12680 |
| Phase 1: Isatuximab 20mg/kg Q2W | 32739 |
| Phase 1: Isatuximab 20mg/kg QW | 28405 |
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting >50% of waking hours; 4=Bedridden or unable to care for self, where lower score indicated good performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the best values (categorized as: Baseline ECOG 1, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 1) are reported. (NCT01084252)
Timeframe: At baseline, during treatment (Day 1 up to 120 weeks)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Baseline ECOG 1, During Treatment ECOG 0 | Baseline ECOG 2, During Treatment ECOG 0 | Baseline ECOG 2, During Treatment ECOG 1 | |
| Phase 1: Isatuximab | 11 | 2 | 11 |
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting>50% of waking hours; 4=Bedridden or unable to care for self, where higher score indicated worst performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the worst values (categorized as: Baseline ECOG 0, During Treatment ECOG 1; Baseline ECOG 2, During Treatment ECOG 1; Baseline ECOG 0, During Treatment ECOG 2; Baseline ECOG 1, During Treatment ECOG 2; Baseline ECOG 0, During Treatment ECOG 3; Baseline ECOG 1, During Treatment ECOG 3; Baseline ECOG 2, During Treatment ECOG 3) are reported. (NCT01084252)
Timeframe: At baseline, during treatment (up to 120 weeks)
| Intervention | Participants (Count of Participants) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline ECOG 0, During Treatment ECOG 1 | Baseline ECOG 2, During Treatment ECOG 1 | Baseline ECOG 0, During Treatment ECOG 2 | Baseline ECOG 1, During Treatment ECOG 2 | Baseline ECOG 0, During Treatment ECOG 3 | Baseline ECOG 1, During Treatment ECOG 3 | Baseline ECOG 2, During Treatment ECOG 3 | |
| Phase 1: Isatuximab | 8 | 1 | 3 | 20 | 1 | 2 | 1 |
OR defined as participants with complete response (CR) or partial response (PR) as best overall response (BOR). Clinical benefit: participants with minimal response (MR) or better as BOR. BOR: best sequential response from start of treatment through the entire study excluding any time point following start of other treatment. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, no increase in size or number of lytic bone lesions. PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. MR: 25 to 49% reduction in serum M-protein, 50-89% reduction in 24h urine M-protein, 25-49% reduction in size of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. (NCT01084252)
Timeframe: From the date of randomization to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| OR | Clinical benefit | |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 16.7 | 27.8 |
| Phase 1: Isatuximab 10mg/kg QW | 33.3 | 33.3 |
| Phase 1: Isatuximab 1mg/kg Q2W | 33.3 | 33.3 |
| Phase 1: Isatuximab 20mg/kg Q2W | 14.3 | 28.6 |
| Phase 1: Isatuximab 20mg/kg QW | 28.6 | 42.9 |
| Phase 1: Isatuximab 3mg/kg Q2W | 0 | 20.0 |
| Phase 1: Isatuximab 5mg/kg Q2W | 33.3 | 33.3 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 28.0 | 28.0 |
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 1) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment. (NCT01084252)
Timeframe: Up to 120 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Treatment-induced ADA | Treatment boosted ADA | |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 1 | 0 |
| Phase 1: Isatuximab 10mg/kg QW | 1 | 0 |
| Phase 1: Isatuximab 20mg/kg Q2W | 1 | 0 |
| Phase 1: Isatuximab 20mg/kg QW | 1 | 0 |
| Phase 1: Isatuximab 3mg/kg Q2W | 0 | 0 |
| Phase 1: Isatuximab 5mg/kg Q2W | 0 | 0 |
| Phase 1:Isatuximab <=1 mg/kg Q2W | 2 | 0 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 1 | 0 |
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 2 Stage 2) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment. (NCT01084252)
Timeframe: Up to 97 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Treatment induced ADA | Treatment boosted ADA | |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 0 | 0 |
| Phase 2 Stage 2: Isatuximab Alone | 1 | 0 |
Serum/plasma markers included: tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1-β), interleukin 6 (IL-6) and interferon-gamma (IFN-Gamma). Due to change in planned analysis, data for high-sensitivity C-reactive protein (hs-CRP) and CD38 was not collected and analyzed. (NCT01084252)
Timeframe: Cycle 1 Day 1
| Intervention | picogram/milliliter (pg/mL) (Mean) | |||
|---|---|---|---|---|
| TNF alpha | IL-1 Beta | IL-6 | IFN Gamma | |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 503.462 | 547.770 | 173.004 | 568.806 |
| Phase 1: Isatuximab 10mg/kg QW | 342.664 | 327.957 | -8.109 | 627.089 |
| Phase 1: Isatuximab 20mg/kg Q2W | 307.319 | 305.914 | 274.616 | 448.387 |
| Phase 1: Isatuximab 20mg/kg QW | 412.541 | 293.307 | 165.295 | 1487.097 |
| Phase 1: Isatuximab 3mg/kg Q2W | 179.783 | 29.741 | 261.732 | 5.376 |
| Phase 1: Isatuximab 5mg/kg Q2W | 352.974 | 7.527 | 73.899 | 25.806 |
| Phase 1:Isatuximab <=1 mg/kg Q2W | 163.181 | 64.577 | 139.234 | 477.116 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 340.799 | 299.058 | 148.594 | 445.772 |
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter. (NCT01084252)
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion
| Intervention | microgram per milliliter (mcg/mL) (Mean) |
|---|---|
| Cycle 1 Day 1 | |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 148.80000 |
| Phase 1: Isatuximab 0.3 mg/kg Q2W | 2.08667 |
| Phase 1: Isatuximab 1 mg/kg Q2W | 13.18333 |
| Phase 1: Isatuximab 20mg/kg Q2W | 400.33333 |
| Phase 1: Isatuximab 3mg/kg Q2W | 44.22500 |
| Phase 1: Isatuximab 5mg/kg Q2W | 125.50000 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 171.43333 |
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter. (NCT01084252)
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion
| Intervention | microgram per milliliter (mcg/mL) (Mean) | |
|---|---|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 | |
| Phase 1: Isatuximab 10mg/kg QW | 173.33333 | 299.82500 |
| Phase 1: Isatuximab 20mg/kg QW | 334.33333 | 715.33333 |
Ctrough is the plasma concentration observed before treatment administration. For 1st category, the accumulation ratio was calculated by dividing Ctrough value of Cycle 2 Day 1 by Cycle 1 Day 8 and for second category, accumulation ratio was calculated by dividing Ctrough value of Cycle 4 Day 1 by Cycle 1 Day 8. (NCT01084252)
Timeframe: Cycle 2, Day 1; Cycle 1, Day 8; Cycle 4, Day 1
| Intervention | ratio (Mean) | |
|---|---|---|
| Cycle 2 Day 1/Cycle 1 Day 8 | Cycle 4 Day 1/Cycle 1 Day 8 | |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 3.24370 | 3.95950 |
| Phase 2 Stage 2: Isatuximab Alone | 521.38338 | 3.58378 |
(NCT01084252)
Timeframe: At Day 1, 8, and 22
| Intervention | mcg/mL (Geometric Mean) | ||
|---|---|---|---|
| Day 7 | Day 14 | Day 28 | |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 128 | 214 | 305 |
| Phase 2 Stage 2: Isatuximab Alone | 137 | 230 | 360 |
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 4 day 1 | Cycle 7 day 1 | Cycle 10 day 1 | Cycle 13 day 1 | End of treatment | |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | -4.78 | 9.00 | 10.33 | -9.00 | -10.00 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 4.89 | 1.00 | -2.60 | -5.00 | -9.00 |
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Cycle 4 day 1 | Cycle 7 day 1 | Cycle 10 day 1 | Cycle 13 day 1 | Cycle 16 day 1 | End of treatment | |
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | -5.75 | -2.50 | 0.50 | 14.00 | 5.00 | -18.50 |
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Cycle 4 day 1 | Cycle 7 day 1 | Cycle 10 day 1 | Cycle 13 day 1 | Cycle 16 day 1 | Cycle 19 day 1 | End of treatment | |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 2.00 | -6.00 | -10.33 | -5.00 | 0.67 | -5.50 | -11.60 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with MM. It has 4 subscales: body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). Disease symptoms subscale used 4-point scale ranged from 1= 'Not at All' to 4= 'Very Much'. Scores were averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 2 day 1 | Cycle 3 day 1 | Cycle 4 day 1 | Cycle 5 day 1 | Cycle 6 day 1 | Cycle 7 day 1 | Cycle 8 day 1 | Cycle 9 day 1 | Cycle 10 day 1 | End of treatment | |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | -3.42 | -5.05 | -3.89 | 0.51 | 1.23 | -3.70 | -2.78 | -10.00 | 0.00 | 7.78 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 0.93 | -5.98 | -10.00 | -9.03 | -15.08 | -18.06 | -15.28 | -16.67 | -15.28 | 24.07 |
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 5.56 | 7.94 | 8.33 | -6.94 | 8.33 | 2.78 | -5.56 | 5.56 | 0.00 | -9.72 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 2.61 | -1.52 | 0.62 | -6.67 | -6.94 | -11.11 | -4.17 | -6.94 | -6.67 | 25.00 |
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) & other single items. For each item, high score = high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and End of Treatment (EOT: anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 2 day 1 | Cycle 3 day 1 | Cycle 4 day 1 | Cycle 5 day 1 | Cycle 6 day 1 | Cycle 7 day 1 | Cycle 8 day 1 | Cycle 9 day 1 | Cycle 10 day 1 | End of treatment | |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 2.22 | -0.76 | -5.30 | 0.69 | -10.19 | -3.57 | -11.11 | -10.00 | -16.67 | -11.67 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | -3.95 | 6.55 | 6.06 | 6.48 | 5.95 | 8.33 | 4.17 | 4.17 | 8.33 | -11.11 |
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | -8.33 | 0.00 | 0.00 | 0.00 | 12.50 | 12.50 | 0.00 | -8.33 | -8.33 | 3.33 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 0.00 | -2.08 | 7.41 | 5.00 | 10.42 | 6.67 | 6.25 | 6.25 | 3.33 | -12.50 |
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| Cycle 1 Day 1 | |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 154 |
| Phase 1: Isatuximab 0.3 mg/kg Q2W | 2.00 |
| Phase 1: Isatuximab 1 mg/kg Q2W | 12.4 |
| Phase 1: Isatuximab 20mg/kg Q2W | 457 |
| Phase 1: Isatuximab 3mg/kg Q2W | 53.7 |
| Phase 1: Isatuximab 5mg/kg Q2W | 126 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 181 |
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | mcg/mL (Geometric Mean) | |
|---|---|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 | |
| Phase 1: Isatuximab 10mg/kg QW | 181 | 265 |
| Phase 1: Isatuximab 20mg/kg QW | 343 | 712 |
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). (NCT01084252)
Timeframe: Week 1, 2 and 3
| Intervention | mcg/mL (Geometric Mean) | ||
|---|---|---|---|
| Week 1 | Week 2 | Week 3 | |
| Phase 1: 5mg/kg Q2W | 15.3 | 1.39 | 42.7 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 44.2 | 8.31 | 18.6 |
| Phase 1: Isatuximab 1 mg/kg Q2W | 0.00223 | 0.000800 | 0.000283 |
| Phase 1: Isatuximab 10 mg/kg QW | 20.7 | 55.1 | 75.9 |
| Phase 1: Isatuximab 20mg/kg Q2W | 113 | 63.9 | 91.0 |
| Phase 1: Isatuximab 20mg/kg QW | 108 | 194.8 | 347.3 |
| Phase 1: Isatuximab 3mg/kg Q2W | 1.44 | 0.181 | 0.460 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 27.6 | 1.97 | 4.18 |
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | hours (Median) |
|---|---|
| Cycle 1 Day 1 | |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 4.92 |
| Phase 1: Isatuximab 0.3 mg/kg Q2W | 2.49 |
| Phase 1: Isatuximab 1 mg/kg Q2W | 4.35 |
| Phase 1: Isatuximab 5mg/kg Q2W | 7.65 |
| Phase 1: Isatuximab 20mg/kg Q2W | 5.87 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 4.28 |
| Phase 1: Isatuximab 3mg/kg Q2W | 6.99 |
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | hours (Median) | |
|---|---|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 | |
| Phase 1: Isatuximab 10mg/kg QW | 2.25 | 4.30 |
| Phase 1: Isatuximab 20mg/kg QW | 6.83 | 8.07 |
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria). (NCT01080391)
Timeframe: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 87.1 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 92.7 |
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS. (NCT01080391)
Timeframe: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
| Intervention | months (Median) |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 18.9 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 28.7 |
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS. (NCT01080391)
Timeframe: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
| Intervention | months (Median) |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 21.2 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 28.6 |
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (NCT01080391)
Timeframe: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 66.7 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 87.1 |
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier. (NCT01080391)
Timeframe: From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
| Intervention | months (Median) |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 40.4 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 48.3 |
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date). (NCT01080391)
Timeframe: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
| Intervention | months (Median) |
|---|---|
| Lenalidomide and Dexamethasone (Rd) | 17.6 |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 26.3 |
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. (NCT01080391)
Timeframe: Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
| Intervention | scores on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 1 Day 1 (Baseline) | Cycle 3, Day 1 | Cycle 6, Day 1 | Cycle 12, Day 1 | Cycle 18, Day 1 | |
| Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 58.3 | 59.9 | 62.5 | 62.7 | 64.3 |
| Lenalidomide and Dexamethasone (Rd) | 58.1 | 56.8 | 58.9 | 57.3 | 59.9 |
Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment. (NCT01712789)
Timeframe: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
| Intervention | Months (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 7.9 |
Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive. (NCT01712789)
Timeframe: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
| Intervention | Months (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 11.9 |
Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted. (NCT01712789)
Timeframe: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
| Intervention | Months (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 4.6 |
Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted). (NCT01712789)
Timeframe: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
| Intervention | Months (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 4.8 |
Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions (NCT01712789)
Timeframe: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 33.4 |
Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data. (NCT01712789)
Timeframe: Cycles 1, 2, 3, 4, 5, 6
| Intervention | Liters/hour (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 6.02 |
Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data. (NCT01712789)
Timeframe: Cycles 1, 2, 3, 4, 5, 6
| Intervention | Liters (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 75.10 |
Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria. (NCT01712789)
Timeframe: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
| Intervention | Weeks (Median) |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 8.1 |
"An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.~A SAE = AE occurring at any dose that:~Results in death;~Is life-threatening~Requires inpatient hospitalization or prolongation of existing hospitalization~Results in persistent or significant disability/incapacity~Is a congenital anomaly/birth defect" (NCT01712789)
Timeframe: From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ≥ TEAE | ≥ 1 TEAE Related to Pomalidomide (POM) | ≥ 1 TEAE Related to LD-Dex | ≥ 1 TEAE Related to Either POM or LD-Dex | ≥ 1 Grade (Gr) 3 or 4 TEAE | ≥ 1 Gr 3 or 4 TEAE Related to (R/T) POM | ≥ 1 Gr 3 or 4 TEAE R/T LD-Dex | ≥ 1 Gr 3 or 4 TEAE R/T Either POM or LD-Dex | ≥ 1 Grade 5 TEAE | ≥ 1 Grade 5 TEAE R/T POM | ≥ 1 Grade 5 TEAE R/T LD-Dex | ≥ 1 Grade 5 TEAE R/T either POM or LD-Dex | ≥ 1 Serious TEAE | ≥ 1 Serious TEAE R/T POM | ≥ 1 Serious TEAE R/T LD-Dex | ≥ 1 Serious TEAE R/T Either POM or LD-Dex | ≥ 1 Serious TEAE Leading to (L/T)Stopping of POM | ≥ 1 Serious TEAE L/T Stopping of LD-Dex | ≥1 Serious TEAE L/T Stopping either POM or LD-Dex | ≥ 1 TEAE L/T to Stopping of POM | ≥ 1 TEAE L/T to Stopping of LD-DEX | ≥ 1 TEAE L/T to Stopping of Either POM or LD-DEX | ≥1 Study Drug Related TEAE (L/T) Stopping POM | ≥1 Study Drug Related TEAE L/T Stopping LD-Dex | ≥1 Drug Related TEAE L/T Stopping LD-Dex or POM | ≥ 1 TEAE L/T to Reduction (R/D) of POM | ≥ 1 TEAE L/T to R/D of LD-DEX | ≥ 1 TEAE L/T to R/D of Either POM or LD-DEX | ≥ 1 Study Drug Related TEAE L/T to R/D of POM | ≥ 1 Study Drug Related TEAE L/T to R/D of LD-DEX | ≥1 StudyDrug Related TEAE L/T to R/D POM or LD-DEX | ≥ 1 TEAE L/T to Interruption (I/R) of POM | ≥ 1 TEAE L/T to I/R of LD-DEX | ≥ 1 TEAE L/T to I/R of either POM or LD-DEX | ≥ 1 Study Drug Related TEAE L/T to I/R of POM | ≥ 1 Study Drug Related TEAE L/T to I/R of LD-DEX | ≥1 StudyDrug Related TEAE L/T to I/R POM or LD-DEX | |
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 673 | 527 | 448 | 575 | 606 | 417 | 226 | 448 | 127 | 14 | 16 | 18 | 448 | 187 | 146 | 215 | 36 | 34 | 37 | 54 | 61 | 63 | 30 | 19 | 38 | 164 | 150 | 244 | 142 | 135 | 224 | 455 | 434 | 470 | 294 | 185 | 333 |
Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma. (NCT01460940)
Timeframe: up to 24 months
| Intervention | percentage of patients (Number) |
|---|---|
| Lenalidomide and Panobinostat | 16.7 |
Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive (NCT01460940)
Timeframe: 3-5 years
| Intervention | months (Median) |
|---|---|
| Lenalidomide and Panobinostat | 3.8 |
Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0 (NCT01460940)
Timeframe: up to 24 months
| Intervention | percentage of patients (Number) | |||
|---|---|---|---|---|
| neutropenia | thrombocytopenia | febrile neutropenia | hypophosphatemia | |
| Lenalidomide and Panobinostat | 58.3 | 41.7 | 25.0 | 25.0 |
DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 38 months
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 26.0 |
| Placebo + Lenalidomide + Dexamethasone | 21.7 |
Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported for high-risk participants. (NCT01564537)
Timeframe: From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 46.9 |
| Placebo + Lenalidomide + Dexamethasone | 30.9 |
ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months(approximate median follow-up 15 months)
| Intervention | percentage of participants (Number) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 78.3 |
| Placebo + Lenalidomide + Dexamethasone | 71.5 |
Data is reported for percentage of participants defined by polymorphism defined by polymorphisms in proteasome genes, such as polymorphism P11A in PSMB1 gene. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
| Intervention | percentage of participants (Number) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 80.3 |
| Placebo + Lenalidomide + Dexamethasone | 75.7 |
Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. (NCT01564537)
Timeframe: From date of randomization until death (up to approximately 97 months)
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 53.6 |
| Placebo + Lenalidomide + Dexamethasone | 51.6 |
Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17). (NCT01564537)
Timeframe: From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 42.2 |
| Placebo + Lenalidomide + Dexamethasone | 29.4 |
Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
| Intervention | percentage of participants (Number) |
|---|---|
| Ixazomib + Lenalidomide + Dexamethasone | 48.1 |
| Placebo + Lenalidomide + Dexamethasone | 39.0 |
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. (NCT01564537)
Timeframe: From date of randomization until disease progression or death up to approximately 38 months (approximate median follow-up 15 months)
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 18.7 |
| Placebo + Lenalidomide + Dexamethasone | 9.3 |
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed. (NCT01564537)
Timeframe: From date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 20.6 |
| Placebo + Lenalidomide + Dexamethasone | 14.7 |
TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
| Intervention | months (Median) |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 22.4 |
| Placebo + Lenalidomide + Dexamethasone | 17.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
| Intervention | score on a scale (Mean) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Global Health Index: Baseline | Global Health Index: End of Treatment | Physical Functioning: Baseline | Physical Functioning: EOT | Role Functioning: Baseline | Role Functioning: EOT | Emotional Functioning: Baseline | Emotional Functioning: EOT | Cognitive Functioning: Baseline | Cognitive Functioning: EOT | Social Functioning: Baseline | Social Functioning: EOT | Fatigue: Baseline | Fatigue: EOT | Pain: Baseline | Pain: EOT | Nausea and Vomiting: Baseline | Nausea and Vomiting: EOT | Dyspnea: Baseline | Dyspnea: EOT | Insomnia: Baseline | Insomnia: EOT | Appetite Loss: Baseline | Appetite Loss: EOT | Constipation: Baseline | Constipation: EOT | Diarrhea: Baseline | Diarrhea: EOT | Financial Difficulties: Baseline | Financial Difficulties: EOT | |
| Ixazomib+ Lenalidomide + Dexamethasone | 58.4 | -6.0 | 70.0 | -4.7 | 68.4 | -8.6 | 75.1 | -2.1 | 81.9 | -7.6 | 77.9 | -6.9 | 38.4 | 6.0 | 38.0 | 2.7 | 5.0 | 3.4 | 21.2 | 5.7 | 27.4 | 0.9 | 16.9 | 4.7 | 12.2 | -1.3 | 6.3 | 17.2 | 16.7 | 0.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
| Intervention | score on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Global Health Index: Baseline | Global Health Index: End of Treatment | Global Health Index: Last Follow-up | Physical Functioning: Baseline | Physical Functioning: EOT | Physical Functioning: Last Follow-up | Role Functioning: Baseline | Role Functioning: EOT | Role Functioning: Last Follow-up | Emotional Functioning: Baseline | Emotional Functioning: EOT | Emotional Functioning: Last Follow-up | Cognitive Functioning: Baseline | Cognitive Functioning: EOT | Cognitive Functioning: Last Follow-up | Social Functioning: Baseline | Social Functioning: EOT | Social Functioning: Last Follow-up | Fatigue: Baseline | Fatigue: EOT | Fatigue: Last Follow-up | Pain: Baseline | Pain: EOT | Pain: Last Follow-up | Nausea and Vomiting: Baseline | Nausea and Vomiting: EOT | Nausea and Vomiting: Last Follow-up | Dyspnea: Baseline | Dyspnea: EOT | Dyspnea: Last Follow-up | Insomnia: Baseline | Insomnia: EOT | Insomnia: Last Follow-up | Appetite Loss: Baseline | Appetite Loss: EOT | Appetite Loss: Last Follow-up | Constipation: Baseline | Constipation: EOT | Constipation: Last Follow-up | Diarrhea: Baseline | Diarrhea: EOT | Diarrhea: Last Follow-up | Financial Difficulties: Baseline | Financial Difficulties: EOT | Financial Difficulties: Last Follow-up | |
| Placebo + Lenalidomide + Dexamethasone | 56.4 | -6.0 | 16.7 | 67.3 | -6.2 | 0.0 | 64.4 | -8.6 | -16.7 | 75.3 | -6.1 | -25.0 | 81.6 | -5.8 | -50.0 | 75.3 | -7.9 | 0.0 | 39.5 | 6.7 | 22.2 | 38.5 | 3.8 | 0.0 | 6.0 | 0.6 | 33.3 | 23.7 | 2.3 | 0.0 | 30.5 | -0.5 | 33.3 | 15.3 | 6.5 | 0.0 | 13.5 | 2.2 | 33.3 | 8.1 | 10.8 | 0.0 | 18.6 | 1.3 | -33.3 |
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
| Intervention | score on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Disease Symptoms: Baseline | Disease Symptoms: EOT | Side Effects of Treatment: Baseline | Side Effects of Treatment: EOT | Side Effects of Treatment: Last Follow-up | Body Image: Baseline | Body Image: EOT | Body Image: Last Follow-up | Future Perspective: Baseline | Future Perspective: EOT | Future Perspective: Last Follow-up | |
| Placebo + Lenalidomide + Dexamethasone | 30.41 | -2.58 | 17.97 | 4.43 | 37.04 | 79.48 | -5.38 | -33.3 | 60.26 | -2.75 | -11.11 |
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
| Intervention | score on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Disease Symptoms: Baseline | Disease Symptoms: EOT | Disease Symptoms: Last Follow-up | Side Effects of Treatment: Baseline | Side Effects of Treatment: EOT | Body Image: Baseline | Body Image: EOT | Future Perspective: Baseline | Future Perspective: EOT | |
| Ixazomib+ Lenalidomide + Dexamethasone | 29.71 | -2.35 | 1.11 | 17.23 | 4.52 | 78.00 | -0.27 | 56.99 | 2.76 |
Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. (NCT01564537)
Timeframe: From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| TEAEs | SAEs | |
| Ixazomib+ Lenalidomide + Dexamethasone | 359 | 205 |
| Placebo + Lenalidomide + Dexamethasone | 357 | 201 |
"Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (worst, least, average, and now [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst)." (NCT01564537)
Timeframe: Baseline and end of treatment (EOT) (up to approximately 38 months)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Baseline | EOT | |
| Ixazomib+ Lenalidomide + Dexamethasone | 345 | 145 |
| Placebo + Lenalidomide + Dexamethasone | 351 | 153 |
(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
| Intervention | μg/mL (Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1, 1 Hour Post-Dose | Cycle 1 Day 1, 4 Hours Post-Dose | Cycle 1 Day 14, Pre-Dose | Cycle 2 Day 1, Pre-Dose | Cycle 2 Day 14, Pre-Dose | Cycle 3 Day 1, Pre-Dose | Cycle 4 Day 1, Pre-Dose | Cycle 5 Day 1, Pre-Dose | Cycle 6 Day 1, Pre-Dose | Cycle 7 Day 1, Pre-Dose | Cycle 8 Day 1, Pre-Dose | Cycle 9 Day 1, Pre-Dose | Cycle 10 Day 1, Pre-Dose | |
| Placebo + Lenalidomide + Dexamethasone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
| Intervention | μg/mL (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | Cycle 1 Day 1, 1 Hour Post-Dose | Cycle 1 Day 1, 4 Hours Post-Dose | Cycle 1 Day 14, Pre-Dose | Cycle 2 Day 1, Pre-Dose | Cycle 2 Day 14, Pre-Dose | Cycle 3 Day 1, Pre-Dose | Cycle 4 Day 1, Pre-Dose | Cycle 5 Day 1, Pre-Dose | Cycle 6 Day 1, Pre-Dose | Cycle 7 Day 1, Pre-Dose | Cycle 8 Day 1, Pre-Dose | Cycle 9 Day 1, Pre-Dose | Cycle 10 Day 1, Pre-Dose | |
| Ixazomib+ Lenalidomide + Dexamethasone | 4.79 | 36.3 | 15.6 | 6.83 | 2.4 | 7.12 | 2.48 | 2.41 | 2.42 | 2.57 | 2.71 | 2.37 | 2.51 | 2.82 |
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. (NCT01145495)
Timeframe: At 12 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Treatment (Lenalidomide, Rituximab) | 47 |
Kaplan-Meier method will be used. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT01145495)
Timeframe: Up to 5 years
| Intervention | proportion of participants (Number) | |||
|---|---|---|---|---|
| 2 Years PFS | 3 Years PFS | 4 Years PFS | 5 Years PFS | |
| Treatment (Lenalidomide, Rituximab) | 0.86 | 0.81 | 0.74 | 0.72 |
Data will be summarized using frequency tables. (NCT01145495)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1-2 Fatigue | Grade 1-2 Diarrhea | Grade 1-2 Rash | Grade 1-2 Febrile neutropenia | Grade 3-4 Neutropenia | Grade 3-4 Lymphopenia | Grade 3-4 Thrombocytopenia | Grade 3-4 Infection | Grade 3-4 Rash | |
| Treatment (Lenalidomide, Rituximab) | 51 | 24 | 21 | 1 | 14 | 6 | 1 | 7 | 5 |
Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. (NCT01568866)
Timeframe: From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.
| Intervention | months (Median) |
|---|---|
| Bortezomib + DEX | 10.4 |
| Carfilzomib + DEX | 21.3 |
"Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline." (NCT01568866)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
| Intervention | percentage of participants (Number) |
|---|---|
| Bortezomib + DEX | 62.6 |
| Carfilzomib + DEX | 76.9 |
"Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).~Median overall survival was estimated using the Kaplan-Meier method." (NCT01568866)
Timeframe: From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.
| Intervention | months (Median) |
|---|---|
| Bortezomib + DEX | 40.0 |
| Carfilzomib + DEX | 47.6 |
"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death." (NCT01568866)
Timeframe: From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
| Intervention | percentage of participants (Number) |
|---|---|
| Bortezomib + DEX | 32.0 |
| Carfilzomib + DEX | 6.0 |
"A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.~For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%." (NCT01568866)
Timeframe: Baseline and 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Bortezomib + DEX | 2.6 |
| Carfilzomib + DEX | 0.0 |
"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).~Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored." (NCT01568866)
Timeframe: From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively
| Intervention | months (Median) |
|---|---|
| Bortezomib + DEX | 9.4 |
| Carfilzomib + DEX | 18.7 |
Pulmonary artery pressure was measured using transthoracic echocardiogram. (NCT01568866)
Timeframe: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
| Intervention | mmHg (Mean) | |||
|---|---|---|---|---|
| Week 12 (n=34, 30) | Week 24 (n=22, 20) | Week 36 (n=12, 14) | End of Treatment (n=21, 14) | |
| Bortezomib + DEX | 0.3 | 1.7 | 4.0 | 3.4 |
| Carfilzomib + DEX | 2.8 | 3.4 | 2.6 | 0.9 |
Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram. (NCT01568866)
Timeframe: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
| Intervention | percent fractional area change (Mean) | |||
|---|---|---|---|---|
| Week 12 (n=40, 40) | Week 24 (n=26, 31) | Week 36 (n=15, 18) | End of Treatment (n=23, 18) | |
| Bortezomib + DEX | -0.7 | 0.7 | -0.5 | 0.4 |
| Carfilzomib + DEX | -1.1 | -1.0 | -0.5 | -1.9 |
(NCT01159574)
Timeframe: From start of treatment, to date of disease progression
| Intervention | days (Mean) |
|---|---|
| All Patients | 272 |
(NCT01159574)
Timeframe: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
| Intervention | cycles (Mean) |
|---|---|
| All Patients | 2.19 |
"Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic~≥ Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy~≥ Grade 4 fatigue persisting > 7 days~Treatment delay for toxicity > 21 days~Hematologic~Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) > 7 days~Febrile neutropenia (ANC < 1,000/mm³ with fever ≥ 38.3ºC)~Grade 4 thrombocytopenia (platelets < 25,000/mm³) for > 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding~Treatment delay for toxicity > 21 days.~The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort." (NCT00603447)
Timeframe: Cycle 1, 28 days
| Intervention | participants (Number) |
|---|---|
| 1: CFZ 15 mg/m² + LEN 10 mg | 0 |
| 2: CFZ 15 mg/m² + LEN 15 mg | 0 |
| 3: CFZ 15 mg/m² + LEN 20 mg | 0 |
| 4: CFZ 20 mg/m² + LEN 20 mg | 0 |
| 5: CFZ 20 mg/m² + LEN 25 mg | 0 |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 1 |
"Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.~Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy." (NCT00603447)
Timeframe: From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Any adverse event | Treatment-related adverse event | Grade 3 or higher adverse event | Treatment-related Grade 3 or higher adverse event | Serious adverse event | AE leading to discontinuation of any study drug | AE leading to discontinuation of carfilzomib | Deaths within 30 days of last dose of study drug | |
| 1: CFZ 15 mg/m² + LEN 10 mg | 6 | 4 | 5 | 1 | 3 | 1 | 0 | 0 |
| 2: CFZ 15 mg/m² + LEN 15 mg | 6 | 5 | 6 | 4 | 3 | 1 | 0 | 0 |
| 3: CFZ 15 mg/m² + LEN 20 mg | 8 | 8 | 8 | 7 | 4 | 3 | 1 | 0 |
| 4: CFZ 20 mg/m² + LEN 20 mg | 6 | 4 | 6 | 4 | 4 | 4 | 2 | 0 |
| 5: CFZ 20 mg/m² + LEN 25 mg | 6 | 6 | 6 | 6 | 3 | 2 | 1 | 0 |
| 6: CFZ 20/27 mg/m² + LEN 25 mg | 8 | 8 | 8 | 8 | 6 | 3 | 1 | 0 |
| 7: CFZ 20/27 mg/m² + LEN 25 mg | 44 | 43 | 41 | 38 | 22 | 18 | 9 | 3 |
In patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a >25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. (NCT00081939)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|---|
| Study Treatment | 77 |
Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 35.1 |
| High-Dose Dexamethasone | 28.1 |
Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | NA |
| High-Dose Dexamethasone | 34.0 |
Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 29 August 2017. Maximum time on follow-up for survival was 324 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 56.1 |
| High-Dose Dexamethasone | 35.3 |
Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 54.0 |
| High-Dose Dexamethasone | 34.9 |
Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee: SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | percentage of participants (Number) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 23.5 |
| High-Dose Dexamethasone | 3.9 |
Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee: CR requires all of the following: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | percentage of participants (Number) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 22.2 |
| High-Dose Dexamethasone | 3.3 |
Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 15.7 |
| High-Dose Dexamethasone | 8.0 |
Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 16.0 |
| High-Dose Dexamethasone | 8.1 |
"Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category. Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, Have you had bone aches or pain?: 1) Not at all, 2) A little, 3) Quite a bit, or 4) Very much." (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 5.7 |
| High-Dose Dexamethasone | 4.1 |
Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score. The categories of the ECOG Performance Status Scale are as follows: -0: Fully active, able to carry on all pre-disease performance without restriction; -1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work; -2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Patients with a score of 3, 4 or 5 were excluded from participating in the study. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 8.1 |
| High-Dose Dexamethasone | 4.3 |
Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function. Renal Function was categorized as (from best to worst): - Normal: creatinine clearance ≥80 mL/min; - Grade 1: creatinine clearance ≥60 to <80 mL/min; - Grade 2 : creatinine clearance ≥45 to < 60 mL/min. Participants with creatinine clearance < 45 mL/min at baseline were excluded from the study. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 4.6 |
| High-Dose Dexamethasone | 4.1 |
Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 20.0 |
| High-Dose Dexamethasone | 9.0 |
Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 8.1 |
| High-Dose Dexamethasone | 10.5 |
Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are: 1) Normal; 2) CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL; 3) CTCAE Grade 2: < 10.0 to <8.0 g/dL. Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study. (NCT01311687)
Timeframe: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 3.4 |
| High-Dose Dexamethasone | 1.3 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | -2.87 | -5.66 | -6.31 | -8.64 | -4.17 |
| Pomalidomide Plus Low-Dose Dexamethasone | 1.22 | 2.40 | 2.44 | 1.91 | 0.19 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | 4.03 | 7.76 | 9.43 | 9.47 | 10.49 |
| Pomalidomide Plus Low-Dose Dexamethasone | 2.43 | 3.26 | 1.71 | 0.21 | 0.99 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom). (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | 0.36 | 2.83 | 3.03 | 2.47 | 10.19 |
| Pomalidomide Plus Low-Dose Dexamethasone | -2.70 | -3.58 | -2.41 | -1.64 | -2.40 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | -3.96 | -9.69 | -8.08 | -5.43 | -4.81 |
| Pomalidomide Plus Low-Dose Dexamethasone | -2.32 | -0.56 | 0.17 | 0.91 | 0.54 |
The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom). (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | 2.61 | 5.35 | 7.46 | 6.89 | 7.30 |
| Pomalidomide Plus Low-Dose Dexamethasone | 2.71 | 3.26 | 3.73 | 4.74 | 4.55 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | -3.75 | -2.36 | -3.03 | 0.00 | -0.93 |
| Pomalidomide Plus Low-Dose Dexamethasone | 0.52 | 2.67 | 0.80 | 0.51 | -2.51 |
The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms. (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5 Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | -1.07 | 0.97 | 1.35 | 1.48 | 2.12 |
| Pomalidomide Plus Low-Dose Dexamethasone | -0.50 | -1.36 | -1.15 | -0.53 | 0.60 |
"EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals perfect health, a score of 0 equals death and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL" (NCT01311687)
Timeframe: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | |
| High-Dose Dexamethasone | -0.02 | -0.06 | -0.07 | -0.04 | -0.12 |
| Pomalidomide Plus Low-Dose Dexamethasone | -0.03 | 0.01 | 0.04 | 0.01 | 0.03 |
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death. (NCT01311687)
Timeframe: From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
| Intervention | Participants (Count of Participants) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any adverse event | Grade 3-4 adverse events | AE related to pomalidomide | AE related to dexamethasone | AE related to either study drug | Grade 3-4 AE related to pomalidomide | Grade 3-4 AE related to dexamethasone | Grade 3-4 AE related to either study drug | Grade 5 adverse events | Serious adverse events (SAEs) | SAE related to pomalidomide | SAE related to dexamethasone | SAE related to either study drug | SAE leading to discontinuation of pomalidomide | SAE leading to discontinuation of dexamethasone | SAE leading to discontinuation of either study dru | AE leading to discontinuation of pomalidomide | AE leading to discontinuation of dexamethasone | AE leading to discontinuation of either study drug | |
| HD-Dex / Pomalidomide | 11 | 8 | 11 | 5 | 11 | 6 | 2 | 6 | 1 | 4 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| High-Dose Dexamethasone | 149 | 127 | 0 | 115 | 115 | 0 | 70 | 70 | 21 | 80 | 0 | 36 | 36 | 0 | 14 | 14 | 0 | 16 | 16 |
| Pomalidomide Plus Low-Dose Dexamethasone | 298 | 266 | 251 | 205 | 271 | 199 | 114 | 212 | 46 | 195 | 89 | 73 | 98 | 20 | 20 | 23 | 30 | 34 | 38 |
Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following: For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM. For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM. See previous outcome measures for definitions of each scale. (NCT01311687)
Timeframe: Assessed on Day 1 of the first 6 treatment cycles.
| Intervention | days (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Global Health Status | Physical Functioning | Emotional Functioning | Fatigue | Pain | Disease Symptoms | Side Effects of Treatment | Health Utility | |
| High-Dose Dexamethasone | 57 | 67 | 85 | 57 | 85 | 106 | 85 | 162 |
| Pomalidomide Plus Low-Dose Dexamethasone | 71 | 128 | 146 | 58 | 92 | 127 | 90 | 225 |
"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas." (NCT01324947)
Timeframe: From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide | 16.0 |
Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria. (NCT01324947)
Timeframe: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide | 28.3 |
Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT01324947)
Timeframe: From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide | 33.6 |
"Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG).~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease." (NCT01324947)
Timeframe: From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide | 19.0 |
"Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas." (NCT01324947)
Timeframe: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
| Intervention | percentage of participants (Number) |
|---|---|
| Pomalidomide | 23.0 |
"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following:~Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.~<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.~No increase in size or number of lytic bone lesions.~Disappearance of soft tissue plasmacytomas.~PR requires all of the following:~≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.~Reduction in 24-hour urinary light chain extraction by ≥90% or to <200 mg, maintained at least 42 days.~For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days." (NCT01324947)
Timeframe: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
| Intervention | percentage of participants (Number) |
|---|---|
| Pomalidomide | 20.3 |
Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator. (NCT01324947)
Timeframe: From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks
| Intervention | weeks (Median) |
|---|---|
| Pomalidomide | 8.3 |
"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:~Results in death;~Is life-threatening;~Requires or prolongs existing inpatient hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Constitutes an important medical event.~The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):~Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death" (NCT01324947)
Timeframe: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
| Intervention | participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any adverse event | Grade 3-4 adverse event | AE related to pomalidomide | Grade 3-4 AE related to pomalidomide | Grade 5 AE | ≥1 Serious AE (SAE) | ≥1 SAE related to pomalidomide | ≥1 SAE leading to stopping pomalidomide | ≥AE leading to discontinuation of pomalidomide | ≥1 study drug related AE leading to stopping POM | ≥1 AE leading to reduction of pomalidomide | ≥1 study drug related AE leading to reducing POM | ≥1 AE leading to interruption of pomalidomide | ≥ 1 study drug related interruption of POM | |
| Pomalidomide | 73 | 64 | 51 | 33 | 19 | 52 | 15 | 6 | 8 | 1 | 11 | 9 | 41 | 25 |
To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (NCT02661022)
Timeframe: For a 28-day cycle, Cycle 1
| Intervention | Participants (Count of Participants) |
|---|---|
| SL-401 7 µg/kg/Day | 7 |
| SL-401 9 µg/kg/Day | 2 |
To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (NCT02661022)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At Least 1 Treatment-Related Treatment-Emergent Adverse Event | Fatigue | Nausea | Pyrexia | Hypoalbuminaemia | Chills | Insomnia | Aspartate aminotransferase increased | Constipation | Dizziness | Flushing | Headache | Hypophosphataemia | Neutropenia | Oedema peripheral | Thrombocytopenia | |
| SL-401 7 µg/kg/Day | 7 | 5 | 5 | 4 | 4 | 4 | 3 | 2 | 2 | 3 | 3 | 2 | 2 | 3 | 3 | 2 |
| SL-401 9 µg/kg/Day | 2 | 1 | 1 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
Overall response rate is defined as complete response + very good partial response + partial response and clinical benefit rate (CR + VGPR + PR + minimal response [MR]) based on International Myeloma Working Group-defined response criteria and the duration of response (DOR) in relapsed refractory multiple myeloma (RRMM) patients. (NCT02661022)
Timeframe: Up to 12 Months
| Intervention | Participants (Count of Participants) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Response Rate | Complete Response | Stringent Complete Response | Very Good Partial Response | Partial Response | Minimal Response | Stable Disease | Progressive Disease | Progressive Disease or Death After Overall Response | Censored | |
| SL-401 7 µg/kg/Day | 5 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 1 | 4 |
| SL-401 9 µg/kg/Day | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Per International Myeloma Working Group Response Criteria, progression/progressive disease is defined as increase of >25% from lowest response value in any 1 of the following: serum M-component (the absolute increase must be >0.5 g/dL)4 and/or urine M-component (the absolute increase must be >200 mg/24 h) and/or; only in patients without measurable serum and urine M-protein, the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL; only in patients without measurable serum and urine M-protein and without measurable disease by FLC levels; bone marrow plasma cell percentage (absolute % must be ≥10%); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder. (NCT02661022)
Timeframe: Up to 12 Months
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Disease Progression | Death | Censored | PFS at 6 Months | PFS at 12 Months | |
| SL-401 7 µg/kg/Day | 1 | 0 | 4 | 4 | 1 |
| SL-401 9 µg/kg/Day | 0 | 0 | 1 | 0 | 0 |
To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (MM) (NCT02661022)
Timeframe: Up to 12 Months
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| At Least 1 TEAE Leading to Discontinuation of Study Drug | Capillary leak syndrome | Metastatic malignant melanoma | Pancreatitis | Thrombocytopenia | |
| SL-401 7 µg/kg/Day | 1 | 0 | 1 | 0 | 0 |
| SL-401 9 µg/kg/Day | 1 | 1 | 0 | 1 | 1 |
"Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.~For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting." (NCT00413036)
Timeframe: Up to 1459 days
| Intervention | Months (Median) |
|---|---|
| Lenalidomide | 18.4 |
"Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD." (NCT00413036)
Timeframe: Up to 1459 days
| Intervention | Months (Median) |
|---|---|
| Lenalidomide | 4.5 |
"Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD." (NCT00413036)
Timeframe: Up to 1459 days
| Intervention | Months (Median) |
|---|---|
| Lenalidomide | 4.5 |
"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD." (NCT00413036)
Timeframe: Up to 1459 days
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Complete Response Unconfirmed (CRu) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease | |
| Lenalidomide | 7 | 21 | 40 | 71 | 78 |
27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods. (NCT00357500)
Timeframe: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
| Intervention | Probability (Number) |
|---|---|
| 5-drug Metronomic Antiangiogenic Regimen | 0.61 |
27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. (NCT00357500)
Timeframe: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
| Intervention | Probability (Number) |
|---|---|
| 5-drug Metronomic Antiangiogenic Regimen | 0.31 |
Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. (NCT00357500)
Timeframe: 27 weeks
| Intervention | proportion of patients (Number) |
|---|---|
| 5-drug Metronomic Antiangiogenic Regimen | .25 |
As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. (NCT00357500)
Timeframe: Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Not Evaluable | |
| 5-drug Metronomic Antiangiogenic Regimen | 1 | 12 | 36 | 47 | 1 |
"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event" (NCT00833833)
Timeframe: Up to Day 28 (Cycle 1)
| Intervention | participants (Number) |
|---|---|
| Phase 1: 2 mg Pomalidomide | 1 |
| Phase 1: 3 mg Pomalidomide | 1 |
| Phase 1: 4 mg Pomalidomide | 2 |
| Phase 1: 5 mg Pomalidomide | 4 |
"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | weeks (Median) |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 32.1 |
| Phase 2: Pomalidomide | NA |
"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | weeks (Median) |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 62.6 |
| Phase 2: Pomalidomide | 59.3 |
"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 67 weeks
| Intervention | weeks (Median) |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 16.6 |
| Phase 2: Pomalidomide | 10.7 |
"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 67 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 76.1 |
| Phase 2: Pomalidomide | 75.0 |
"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | weeks (Median) |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 8.1 |
| Phase 2: Pomalidomide | 8.9 |
"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.~Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 126
| Intervention | percentage of participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 or more (1+) AE | 1+ AE related to pomalidomide | 1+ AE related to dexamethasone | 1+ severity grade 3-4 AE | 1+ severity grade 3-4 AE related to pomalidomide | 1+ severity grade 3-4 AE related to dexamethasone | 1+ serious AE (SAE) | 1+ SAE related to pomalidomide | 1+ SAE related to dexamethasone | 1+ AE leading to discontinuation of pomalidomide | 1+ AE -- discontinuation of dexamethasone | 1+AE -dose reduction/interruption of pomalidomide | 1+ AE-dose reduction/interruption of dexamethasone | 1+related AE-reduction/interruption of pomalidomid | 1+related AE-reduction/interruption of dexamethaso | |
| Phase 1: 2 mg Pomalidomide | 100.0 | 100.0 | 100.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Phase 1: 3 mg Pomalidomide | 100.0 | 75.0 | 75.0 | 75.0 | 75.0 | 75.0 | 75.0 | 25.0 | 50.0 | 25.0 | 25.0 | 50.0 | 75.0 | 25.0 | 75.0 |
| Phase 1: 4 mg Pomalidomide | 90.0 | 80.0 | 70.0 | 70.0 | 20.0 | 20.0 | 40.0 | 20.0 | 10.0 | 20.0 | 20.0 | 40.0 | 60.0 | 20.0 | 20.0 |
| Phase 1: 5 mg Pomalidomide | 100.0 | 100.0 | 85.7 | 57.1 | 42.9 | 0.0 | 28.6 | 0.0 | 0.0 | 0.0 | 0.0 | 71.4 | 71.4 | 57.1 | 42.9 |
"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 104
| Intervention | percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 or more (1+) AE | 1+ AE related to pomalidomide | 1+ severity grade 3-4 AE | 1+ severity grade 3-4 AE related to pomalidomide | 1+ serious AE (SAE) | 1+ SAE related to pomalidomide | 1+ AE leading to discontinuation of pomalidomide | 1+AE-dose reduction/interruption of pomalidomide | 1+related AE-reduction/interruption of pomalidomid | |
| Phase 1: 2 mg Pomalidomide | 100.0 | 66.7 | 83.3 | 33.3 | 50.0 | 0.0 | 16.7 | 16.7 | 0.0 |
| Phase 1: 3 mg Pomalidomide | 100.0 | 75.0 | 37.5 | 25.0 | 12.5 | 12.5 | 0.0 | 75.0 | 37.5 |
| Phase 1: 4 mg Pomalidomide | 100.0 | 85.7 | 78.6 | 42.9 | 42.9 | 7.1 | 21.4 | 42.9 | 28.6 |
| Phase 1: 5 mg Pomalidomide | 100.0 | 100.0 | 80.0 | 70.0 | 30.0 | 10.0 | 0.0 | 80.0 | 70.0 |
"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 70
| Intervention | percentage of participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 or more (1+) AE | 1+ AE related to pomalidomide | 1+ severity grade 3-4 AE | 1+ severity grade 3-4 AE related to pomalidomide | 1+ serious AE (SAE) | 1+ SAE related to pomalidomide | 1+ AE leading to discontinuation of pomalidomide | 1+related AE --discontinuation of pomalidomide | 1+AE - reduction of pomalidomide | 1+ AE - interruption of pomalidomide | 1+ related AE - interruption of pomalidomide | 1+related AE - reduction of pomalidomide | |
| Phase 2: Pomalidomide (Overall) | 100.0 | 88.8 | 89.7 | 67.3 | 67.3 | 20.6 | 12.1 | 3.7 | 29.9 | 58.9 | 32.7 | 24.3 |
| Phase 2: Pomalidomide (Pom + Dex Only) | 93.4 | 68.9 | 70.5 | 44.3 | 47.5 | 19.7 | 3.3 | 1.6 | 9.8 | 36.1 | 21.3 | 8.2 |
| Phase 2: Pomalidomide (Pom Only) | 99.1 | 87.9 | 84.1 | 58.9 | 46.7 | 9.3 | 10.3 | 2.8 | 25.2 | 47.7 | 24.3 | 20.6 |
| Phase 2: Pomalidomide + Dexamethasone | 100.0 | 89.3 | 88.4 | 62.5 | 61.6 | 17.9 | 8.0 | 1.8 | 20.5 | 63.4 | 27.7 | 17.9 |
"IRAC used EBMT criteria to assess myeloma response:~Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)~Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others~Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others~Stable Disease (SD)- not MR or progressive disease (PD)~Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other~Not Evaluable (NE).~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Complete response (CR) | Partial response (PR) | Minimal response (MR) | Stable disease (SD) | Progressive disease (PD) | Not evaluable | |
| Phase 2: Pomalidomide | 0.0 | 9.3 | 15.7 | 46.3 | 15.7 | 13.0 |
| Phase 2: Pomalidomide + Dexamethasone | 0.9 | 29.2 | 15.0 | 35.4 | 6.2 | 13.3 |
Will be monitored simultaneously for each of the subgroups separately using the Bayesian approach of Thall, Simon, Estey. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be will be utilized to assess the effect of patient prognostic factors on the response rate. (NCT00695786)
Timeframe: At the end of 3 courses (84 days)
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Best Overall Response - CR | Best Overall Response - CRu Response | Best Overall Response - PR | Best Overall Response - SD | Best Overall Response - PD | Best Overall Response - Inevaluable | |
| Follicular Lymphoma | 56 | 13 | 6 | 1 | 0 | 3 |
| Marginal Zone Lymphoma | 17 | 2 | 4 | 3 | 1 | 4 |
| Other Histology | 0 | 0 | 1 | 0 | 0 | 1 |
| Small Lymphocytic Lymphoma | 8 | 5 | 21 | 3 | 6 | 1 |
All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart. (NCT01319422)
Timeframe: Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days)
| Intervention | percentage of participants (Number) |
|---|---|
| Pomalidomide 2 mg/d on 28 Days/28 Day Cycle | 15.8 |
| Pomalidomide 4 mg/d on 21 Days/28 Day Cycle | 20.0 |
All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart. (NCT01319422)
Timeframe: After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| cycle 4 | cycle 6 | cycle 8 | cycle 10 | cycle 12 | cycle 14 | |
| Pomalidomide 2 mg/d on 28 Days/28 Day Cycle | 15.8 | 21.0 | 21.0 | 21.0 | 21.0 | 21.0 |
| Pomalidomide 4 mg/d on 21 Days/28 Day Cycle | 40.0 | 40.0 | 45.0 | 45.0 | 45.0 | 45.0 |
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease. (NCT00238238)
Timeframe: Duration of treatment (12 cycles)
| Intervention | percentage of participants (Number) |
|---|---|
| Arm II - Lenalidomide | 53.3 |
| Arm III - Lenalidomide and Rituximab | 76.1 |
Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method. (NCT00238238)
Timeframe: Up to 10 years
| Intervention | years (Median) |
|---|---|
| Arm II - Lenalidomide | 1.1 |
| Arm III - Lenalidomide and Rituximab | 2 |
Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 69.6 |
| Investigators Choice | 45.1 |
Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 70.1 |
| Investigators Choice | 91.7 |
Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; overall median follow-up was 93.9 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 121.0 |
| Investigators Choice | 91.7 |
Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to the study discontinuation date of 09 October 2018; overall median follow-up time was 285 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 120.6 |
| Investigators Choice | 91.7 |
PFS was defined as time of randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 37.6 |
| Investigators Choice | 22.7 |
Kaplan Meier estimates of PFS were defined as the time from randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last completed assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 37.3 |
| Investigators Choice | 23.6 |
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. ). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From randomization of study drug to time of first documented PR or better response; up to data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 18.7 |
| Investigators Choice | NA |
Time to first response was defined as the time from first dose of study drug to the date of the first response (having at least a PR). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the subject was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 23.9 |
| Investigators Choice | 40.0 |
Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 39.3 |
| Investigators Choice | 24.7 |
Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
| Intervention | Weeks (Median) |
|---|---|
| Lenalidomide | 39.3 |
| Investigators Choice | 24.7 |
Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From the date of the first treatment to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 24.4 |
| Investigators Choice | 17.9 |
Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From date of first dose of treatment to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide | 24.4 |
| Investigators Choice | 17.9 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -4.8 |
| Investigators Choice | -4.1 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 3.2 |
| Investigators Choice | 2.9 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -0.3 |
| Investigators Choice | -3.5 |
"The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Diarhoea Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement." (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Lenalidomide | -7.2 |
| Investigators Choice | -5.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -7.3 |
| Investigators Choice | -5.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 6.9 |
| Investigators Choice | 3.7 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -4.9 |
| Investigators Choice | -2.9 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -10.9 |
| Investigators Choice | -2.3 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Scale was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 4.6 |
| Investigators Choice | 5.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -12.8 |
| Investigators Choice | -7.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -2.3 |
| Investigators Choice | -0.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | -5.8 |
| Investigators Choice | -3.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 3.4 |
| Investigators Choice | -1.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 3.1 |
| Investigators Choice | 5.0 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) |
|---|---|
| Lenalidomide | 5.1 |
| Investigators Choice | 3.8 |
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who discontinued before any response had been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Percentage of Participants (Number) |
|---|---|
| Lenalidomide | 40.0 |
| Investigators Choice | 10.7 |
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
| Intervention | Percentage of Participants (Number) |
|---|---|
| Lenalidomide | 45.9 |
| Investigators Choice | 22.6 |
Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Percentage of Participants (Number) |
|---|---|
| Lenalidomide | 69.4 |
| Investigators Choice | 63.1 |
Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
| Intervention | Percentage of participants (Number) |
|---|---|
| Lenalidomide | 70.0 |
| Investigators Choice | 65.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 16.2 | -0.8 | 5.1 | -12.5 | -11.1 | 5.4 |
| Lenalidomide | 18.1 | 2.5 | 1.9 | -2.3 | -4.3 | 4.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 83.6 | -2.3 | 1.3 | 4.2 | 5.6 | -2.3 |
| Lenalidomide | 84.6 | 0.0 | -1.9 | -3.2 | -2.5 | -5.1 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 8.6 | -0.8 | 1.3 | 0.0 | 0.0 | 0.8 |
| Lenalidomide | 12.5 | 6.3 | 4.2 | 3.5 | -0.7 | 10.2 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarhoea Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 12.6 | -3.1 | 1.3 | -4.2 | 0.0 | 0.0 |
| Lenalidomide | 15.7 | -3.5 | -4.2 | 2.4 | -2.1 | 1.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 21.2 | -0.8 | 0.0 | 4.2 | 5.6 | 0.8 |
| Lenalidomide | 26.5 | -1.6 | -1.4 | -2.9 | 1.4 | 6.0 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 78.5 | 1.3 | 1.3 | -3.1 | 1.4 | -1.5 |
| Lenalidomide | 73.7 | 3.4 | 3.6 | 8.1 | 4.5 | -1.3 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 39.2 | 2.1 | 3.4 | -6.9 | -7.4 | 2.6 |
| Lenalidomide | 40.2 | 0.1 | -3.2 | -1.0 | -3.9 | 5.2 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 10.8 | -0.8 | -3.8 | -4.2 | -5.6 | 1.6 |
| Lenalidomide | 19.5 | -7.0 | -7.0 | -2.9 | -9.2 | -4.3 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 58.4 | 2.3 | 3.2 | 7.3 | 8.3 | -1.0 |
| Lenalidomide | 59.0 | -3.4 | -0.7 | 1.0 | 4.3 | -5.8 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 25.7 | -4.7 | -6.4 | -16.7 | -16.7 | 0.8 |
| Lenalidomide | 29.4 | -7.6 | -5.2 | -1.8 | -7.1 | -3.2 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 3.8 | 0.4 | 5.8 | 2.1 | 2.8 | 6.6 |
| Lenalidomide | 4.9 | 2.5 | 2.6 | 5.3 | -0.7 | 0.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Cycle 3 Day 1 | Cycle 5 Day 1 | Cycle 7 Day 1 | Cycle 9 Day 1 | Treatment Discontinuation | |
| Investigators Choice | 13.7 | -1.2 | -2.6 | 0.0 | -2.8 | 3.5 |
| Lenalidomide | 22.6 | -2.2 | -0.2 | 3.2 | -3.2 | 4.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 78.9 | -3.7 | -2.1 | 4.2 | 11.1 | -5.1 |
| Lenalidomide | 71.8 | -0.5 | 1.6 | 2.4 | 2.8 | -5.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 73.9 | 3.5 | -6.4 | 0.0 | 13.9 | -4.3 |
| Lenalidomide | 71.5 | -4.8 | 1.4 | 0.3 | 1.8 | -9.1 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation | |
| Investigators Choice | 78.4 | -1.2 | -4.5 | 2.1 | 0.0 | -2.7 |
| Lenalidomide | 74.9 | -1.0 | 1.6 | -1.5 | 4.3 | -5.1 |
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A Treatment Emergent Adverse event (TEAE) is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. (NCT00875667)
Timeframe: From the date of the first dose of study drug to 28 days after the last dose, up to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigators choice arm
| Intervention | Participants (Count of Participants) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any TEAE | Any TEAE Grade 3 AE | Any TEAE Grade 4 AE | Any TEAE Grade 5 AE | Any TEAE Related to the IP | Any Grade 3 AE Related to IP | Any Grade 4 AE Related to IP | Any Grade 5 AE Related to IP | Any Serious Adverse Event (SAE) | Any SAE Related to IP | Any TEAE Leading to Stopping of IP | Any Treatment Related AE Leading to Stopping IP | TEAE Leading to Dose Reduction/Interruption | Related AE Leading to Dose Reduct/Interruption | TEAE Leading to Dose Reduction | Related AE Leading to Dose Reduction | TEAE Leading to Dose Interruption | Related AE Leading to Dose Interruption | |
| Investigators Choice | 69 | 49 | 29 | 2 | 51 | 36 | 19 | 0 | 22 | 12 | 14 | 7 | 33 | 29 | 13 | 10 | 28 | 25 |
| Lenalidomide | 159 | 126 | 56 | 15 | 141 | 106 | 46 | 0 | 75 | 38 | 31 | 18 | 114 | 103 | 72 | 69 | 110 | 98 |
The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate. (NCT00179660)
Timeframe: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
| Intervention | months (Median) |
|---|---|
| Lenalidomide | 10.2 |
The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate. (NCT00179660)
Timeframe: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
| Intervention | months (Median) |
|---|---|
| Lenalidomide | 6.0 |
"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD." (NCT00179660)
Timeframe: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Lenalidomide | 34.7 |
"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy." (NCT00179660)
Timeframe: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Lenalidomide | 59.2 |
"Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.~Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment." (NCT00179660)
Timeframe: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.
| Intervention | months (Median) |
|---|---|
| Lenalidomide | 3.6 |
"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event." (NCT00179660)
Timeframe: From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 15.2 months.
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Any adverse event | Adverse event related to study drug | Grade 3-5 adverse event | Grade 3-5 adverse event related to study drug | Serious adverse event | Serious adverse event related to study drug | AE leading to discontinuation of study drug | Related AE leading to study drug discontinuation | AE leading to dose reduction or interruption | |
| Lenalidomide | 49 | 42 | 36 | 27 | 21 | 6 | 9 | 4 | 28 |
"Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | days (Median) |
|---|---|
| V-DR | NA |
| VDCR | NA |
| V-DC | NA |
| VDC-mod | NA |
Evaluate the safety and tolerability of the combination therapy (NCT00507442)
Timeframe: From first dose of study drug through the 30 day post-treatment AE assessment visit
| Intervention | participants (Number) |
|---|---|
| V-DR | 42 |
| VDCR | 65 |
| V-DC | 33 |
| VDC-mod | 17 |
"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h" (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|---|
| V-DR | 21 |
| VDCR | 23 |
| V-DC | 13 |
| VDC-mod | 9 |
"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|---|
| V-DR | 17 |
| VDCR | 14 |
| V-DC | 10 |
| VDC-mod | 8 |
"Overall Response includes complete response and partial response.~Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|---|
| V-DR | 35 |
| VDCR | 35 |
| V-DC | 24 |
| VDC-mod | 17 |
Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|---|
| V-DR | 7 |
| VDCR | 6 |
| V-DC | 3 |
| VDC-mod | 5 |
Overall survival is defined as time from the date of randomization to the date of death (NCT00507442)
Timeframe: Up to 48 weeks or until death
| Intervention | days (Median) |
|---|---|
| V-DR | NA |
| VDCR | NA |
| V-DC | NA |
| VDC-mod | NA |
(NCT00507442)
Timeframe: survival probability at 1 year after randomization
| Intervention | percentage of patients (Number) |
|---|---|
| V-DR | 100 |
| VDCR | 91.6 |
| V-DC | 100 |
| VDC-mod | 100 |
"Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression/death
| Intervention | days (Median) |
|---|---|
| V-DR | NA |
| VDCR | 631 |
| V-DC | NA |
| VDC-mod | NA |
"Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | days (Median) |
|---|---|
| V-DR | NA |
| VDCR | NA |
| V-DC | NA |
| VDC-mod | NA |
Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments. (NCT00507442)
Timeframe: Up to 48 weeks or until disease response
| Intervention | days (Median) |
|---|---|
| V-DR | 49 |
| VDCR | 50 |
| V-DC | 55 |
| VDC-mod | 49 |
Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression. (NCT00424047)
Timeframe: Up to data cut off of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 67.6 |
| Placebo Plus Dexamethasone | 33.3 |
Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression. (NCT00424047)
Timeframe: Up to data cut off of 03 Mar 2008; up to 51 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 68.1 |
| Placebo Plus Dexamethasone | 33.3 |
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT00424047)
Timeframe: Randomization to data cut off of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | NA |
| Placebo Plus Dexamethasone | NA |
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT00424047)
Timeframe: Randomization to data cut off of 02 March 2008; up to 51 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 161.9 |
| Placebo Plus Dexamethasone | 133.3 |
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. (NCT00424047)
Timeframe: From randomization up to cut-off date of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 52.1 |
| Placebo Plus Dexamethasone | 20.1 |
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. (NCT00424047)
Timeframe: From randomization up to cut-off date of 02 March 2008; up to 51 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 52.4 |
| Placebo Plus Dexamethasone | 20.1 |
Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone). (NCT00424047)
Timeframe: Up to unblinding data cut off of 03 August 2005; up to 24 months
| Intervention | participants (Number) |
|---|---|
| Lenalidomide Plus Dexamethasone | NA |
| Placebo Plus Dexamethasone | NA |
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented. (NCT00424047)
Timeframe: Randomization to cut off date of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 10.1 |
| Placebo Plus Dexamethasone | 12.3 |
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented. (NCT00424047)
Timeframe: Randomization to cut off date of 02 March 2008; up to 51 months
| Intervention | weeks (Median) |
|---|---|
| Lenalidomide Plus Dexamethasone | 10.1 |
| Placebo Plus Dexamethasone | 12.3 |
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma. (NCT00424047)
Timeframe: Randomization to data cut-off of 02 Mar 2008; up to 51 months
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable (NE) those without response data | |
| Lenalidomide Plus Dexamethasone | 17.0 | 42.6 | 28.4 | 3.4 | 8.5 |
| Placebo Plus Dexamethasone | 4.0 | 19.4 | 56.6 | 14.3 | 5.7 |
"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.~The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death." (NCT00424047)
Timeframe: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
| Intervention | participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ≥ 1 Adverse Event | ≥ 1 Serious Adverse Event | ≥ 1 AE leading to study drug discontinuation | ≥ 1 AE leading to dose reduction or interruption | ≥ 1 Drug-Related Adverse Event | ≥ 1 Drug-Related Serious Adverse Event | ≥Death within ≤ 30 days of last dose of study drug | ≥ 1 Grade 1 or Higher Adverse Event | ≥ 1 Grade 2 or Higher Adverse Event | ≥ 1 Grade 3 or Higher Adverse Event | ≥ 1 Grade 4 or Higher Adverse Event | |
| Lenalidomide Plus Dexamethasone | 176 | 105 | 46 | 137 | 160 | 54 | 17 | 176 | 168 | 146 | 52 |
| Placebo Plus Dexamethasone | 175 | 79 | 31 | 100 | 151 | 30 | 20 | 175 | 167 | 119 | 37 |
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma. (NCT00424047)
Timeframe: Randomization to 03 August 2005; up to 24 months
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable (NE) those without response data | |
| Lenalidomide Plus Dexamethasone | 15.3 | 43.8 | 29.0 | 2.8 | 9.1 |
| Placebo Plus Dexamethasone | 4.0 | 19.4 | 56.6 | 14.3 | 5.7 |
The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens. (NCT00056160)
Timeframe: Up to Unblinding (07 Jun 2005)
| Intervention | Participants (Number) |
|---|---|
| CC-5013/Dex | 107 |
| Placebo/Dex | 34 |
Overall survival was calculated as the time from randomization to death from any cause. (NCT00056160)
Timeframe: 170 weeks (median overall survival of CC-5013/Dex treatment group)
| Intervention | Weeks (Median) |
|---|---|
| CC-5013/Dex | 170.1 |
| Placebo/Dex | 136.4 |
The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization. (NCT00056160)
Timeframe: 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
| Intervention | Weeks (Mean) |
|---|---|
| CC-5013/Dex | 29.9 |
| Placebo/Dex | 15.0 |
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123. (NCT00056160)
Timeframe: 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
| Intervention | Weeks (Median) |
|---|---|
| CC-5013/Dex | 60.1 |
| Placebo/Dex | 20.1 |
(NCT01160484)
Timeframe: First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.
| Intervention | months (Median) |
|---|---|
| DVD-R Single Arm | 12 |
time that patients were monitored for disease progression and overall survival (NCT01160484)
Timeframe: Follow-up visits for disease progression and overall survival every 3 months after study discontinuation. After progression, follow-up visits for survival status every 6 months or until alternate therapy needs to be started or death intervenes
| Intervention | months (Median) |
|---|---|
| DVD-R Single Arm | 11 |
(NCT01160484)
Timeframe: Time from the start of treatment to progressive disease or until death
| Intervention | months (Median) |
|---|---|
| DVD-R Single Arm | 9 |
(NCT01160484)
Timeframe: Up to 7.5 months (eight 28-day cycles)
| Intervention | months (Median) |
|---|---|
| DVD-R Single Arm | 2 |
(NCT01160484)
Timeframe: Up to 7.5 months (eight 28-day cycles)
| Intervention | months (Median) |
|---|---|
| DVD-R Single Arm | 1 |
(NCT01160484)
Timeframe: Time from the start of treatment to progressive disease
| Intervention | months (Median) |
|---|---|
| DVD-R Single Arm | 9 |
The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response. (NCT01160484)
Timeframe: Up to 7.5 months (eight 28-day cycles)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| CR | VGPR | PR | Objective Response (CR+VGPR+PR) | MR | Clinical Benefit (CR+VGPR+PR+MR) | Estable disease | Progressive disease | |
| DVD-R Single Arm | 8 | 4 | 7 | 19 | 14 | 33 | 4 | 2 |
(NCT01453088)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|---|
| Auto Transplant High Dose Melphalan | 27 |
| Auto Transplant High Dose Melphalan+Bortezomib | 27 |
Progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib at 3 years (NCT01453088)
Timeframe: Participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely
| Intervention | Participants (Count of Participants) |
|---|---|
| Auto Transplant High Dose Melphalan | 13 |
| Auto Transplant High Dose Melphalan+Bortezomib | 11 |
Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 4 cycles
| Intervention | Percentage of Participants (Number) |
|---|---|
| FCR With Lenalidomide | 45 |
Analysis of the other Secondary Endpoints: The overall response rate will be estimated by the number of patients with complete and partial responses divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 6 cycles
| Intervention | Percentage of Participants (Number) |
|---|---|
| FCR With Lenalidomide | 95 |
Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999). (NCT00783367)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort 1 | 14 |
| Cohort 2 | 13 |
Progression free survival time in months (NCT00783367)
Timeframe: 9 years from enrollment of first subject
| Intervention | months (Median) |
|---|---|
| Cohort 1 | 22.2 |
| Cohort 2 | 22.4 |
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT00103506)
Timeframe: Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)
| Intervention | Participants (Number) |
|---|---|
| Velcade (Bortezomib) Monotherapy | 105 |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 120 |
The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive. (NCT00103506)
Timeframe: Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)
| Intervention | months (Median) |
|---|---|
| Velcade (Bortezomib) Monotherapy | 30.8 |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 33.0 |
Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date. (NCT00103506)
Timeframe: Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])
| Intervention | Months (Median) |
|---|---|
| Velcade (Bortezomib) Monotherapy | 6.5 |
| Doxil/Caelyx Plus Velcade (Bortezomib) | 9.3 |
Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response. (NCT00267059)
Timeframe: Evaluated after three 28-day cycles of lenalidomide.
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Complete Response | Complete Response With Nodules | Partial Response | No Response | |
| Lenalidomide | 3 | 1 | 10 | 30 |
Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00047879)
Timeframe: 4 months
| Intervention | Participants (Number) |
|---|---|
| Glioblastoma Multiforme Stratum | 4 |
| Anaplastic Glioma Stratum | 2 |
47 reviews available for thalidomide and Local Neoplasm Recurrence
| Article | Year |
|---|---|
Lenalidomide-induced arthritis: A case report and review of literature and pharmacovigilance databases.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Arthritis; Cyclophosphamide; Doxorubici | 2022 |
Sequencing multiple myeloma therapies with and after antibody therapies.
Topics: Aged; Antineoplastic Agents, Immunological; Antineoplastic Combined Chemotherapy Protocols; Bortezom | 2020 |
An evaluation of isatuximab, pomalidomide and dexamethasone for adult patients with relapsed and refractory multiple myeloma.
Topics: Adult; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethas | 2021 |
[Research Advance in Light Chain Escape of Multiple Myeloma -Review].
Topics: Bortezomib; Humans; Immunoglobulin G; Immunoglobulin Light Chains; Multiple Myeloma; Neoplasm Recurr | 2017 |
Monoclonal Antibodies versus Histone Deacetylase Inhibitors in Combination with Bortezomib or Lenalidomide plus Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma: An Indirect-Comparison Meta-Analysis of Randomized Controlled Trial
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Combined Modalit | 2018 |
[Daratumumab for multiple myeloma].
Topics: Antibodies, Monoclonal; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Borte | 2018 |
[First-line treatment of multiple myeloma].
Topics: Antineoplastic Agents; Bortezomib; Germany; Humans; Lenalidomide; Multiple Myeloma; Neoplasm Recurre | 2019 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Tri | 2013 |
Recent advances in the management of mantle cell lymphoma.
Topics: Adolescent; Adult; Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal, Murine-Derived; Antineopla | 2013 |
New treatment options for chronic lymphocytic leukemia.
Topics: Antibodies, Monoclonal; Antineoplastic Agents; Apoptosis; Humans; Immunotherapy; Lenalidomide; Leuke | 2014 |
Therapeutic options in relapsed or refractory peripheral T-cell lymphoma.
Topics: Alemtuzumab; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplastic Combined Chemo | 2014 |
Relapsed and refractory multiple myeloma: new therapeutic strategies.
Topics: Antineoplastic Combined Chemotherapy Protocols; Drug Resistance, Neoplasm; Humans; Multiple Myeloma; | 2014 |
Pomalidomide for multiple myeloma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Hu | 2014 |
[Pomalidomide in the treatment of relapsed and refractory multiple myeloma].
Topics: Administration, Oral; Boronic Acids; Bortezomib; Dexamethasone; Disease-Free Survival; Humans; Immun | 2014 |
Current treatment landscape for relapsed and/or refractory multiple myeloma.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Boronic Acids; Bortezomib; Hematopoietic Stem Cell T | 2015 |
The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use.
Topics: Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Dexamethasone; Disease Pr | 2015 |
Multiple myeloma: Updates for pharmacists in the treatment of relapsed and refractory disease.
Topics: Antineoplastic Agents; Clinical Trials as Topic; Histone Deacetylase Inhibitors; Humans; Immunologic | 2016 |
Waldenstrom macroglobulinemia: prognosis and management.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; H | 2015 |
Novel biologic agents for non-Hodgkin lymphoma and chronic lymphocytic leukemia-part 2: adoptive cellular immunotherapy, small-molecule inhibitors, and immunomodulation.
Topics: Aniline Compounds; Antineoplastic Agents; Clinical Trials as Topic; Humans; Immunomodulation; Immuno | 2015 |
Lenalidomide for mantle cell lymphoma.
Topics: Angiogenesis Inhibitors; Animals; Humans; Immunologic Factors; Lenalidomide; Lymphoma, Mantle-Cell; | 2015 |
Multiple myeloma: from front-line to relapsed therapies.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Cisp | 2015 |
Carfilzomib and pomalidomide in patients with relapsed and/or refractory multiple myeloma with baseline risk factors.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Clinical Trials as Topic; Humans; Multiple Myeloma; | 2015 |
Bone formation following lenalidomide-dexamethasone combination therapy in cases of multiple myeloma refractory to high-dose chemotherapy with bortezomib and autologous peripheral blood stem cell transplantation: report of a case and review of the literat
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Humans; Immunologi | 2015 |
Current and emerging triplet combination therapies for relapsed and refractory multiple myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Borte | 2016 |
Maintenance therapy for multiple myeloma in the era of novel agents.
Topics: Clinical Trials, Phase III as Topic; Dexamethasone; Disease-Free Survival; Flow Cytometry; Hematolog | 2015 |
[Changes in the prognosis and treatment of Waldenström macroglobulinemia. Literature overview and own experience].
Topics: Adenine; Anemia; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protoc | 2016 |
Pomalidomide in the management of relapsed multiple myeloma.
Topics: Antineoplastic Agents; Clinical Trials as Topic; Humans; Multiple Myeloma; Neoplasm Recurrence, Loca | 2016 |
Carfilzomib/pomalidomide single-agent or in combination with other agents for the management of relapsed/refractory multiple myeloma: a meta-analysis of 37 trials.
Topics: Antineoplastic Combined Chemotherapy Protocols; Disease Management; Drug Resistance, Neoplasm; Human | 2017 |
Update on elotuzumab, a novel anti-SLAMF7 monoclonal antibody for the treatment of multiple myeloma.
Topics: Animals; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemothe | 2016 |
Current multiple myeloma treatment strategies with novel agents: a European perspective.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Ch | 2010 |
Lenalidomide in multiple myeloma: current role and future directions.
Topics: Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Dexamethasone; Humans; Len | 2010 |
Advances in treatment for relapses and refractory multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Humans; Multiple Myeloma; | 2010 |
Treatment of relapsed and refractory myeloma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; De | 2009 |
Integrating novel agents into multiple myeloma treatment - current status in Switzerland and treatment recommendations.
Topics: Aged; Antineoplastic Agents; Biopsy, Needle; Bone Marrow; Bone Marrow Transplantation; Boronic Acids | 2010 |
Postrelapse survival rate correlates with first-line treatment strategy with thalidomide in patients with newly diagnosed multiple myeloma: a meta-analysis.
Topics: Angiogenesis Inhibitors; Humans; Meta-Analysis as Topic; Multiple Myeloma; Neoplasm Recurrence, Loca | 2012 |
Intermediate dose thalidomide (200 mg daily) has comparable efficacy and less toxicity than higher doses in relapsed multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Dose-Response Relationship, Drug; Humans; Middle Aged; Multipl | 2003 |
Dyspnea during thalidomide treatment for advanced ovarian cancer.
Topics: Adult; Aged; Dyspnea; Female; Humans; Immunosuppressive Agents; Middle Aged; Neoplasm Recurrence, Lo | 2005 |
A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myeloma.
Topics: Clinical Trials, Phase II as Topic; Data Collection; Dose-Response Relationship, Drug; Drug Administ | 2006 |
Evaluation of recurring cytogenetic abnormalities in the treatment of myelodysplastic syndromes.
Topics: Chromosome Aberrations; Chromosomes, Human, Pair 5; Humans; Karyotyping; Lenalidomide; Myelodysplast | 2007 |
Management of multiple myeloma with bortezomib: experts review the data and debate the issues.
Topics: Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2006 |
Neurotoxicity of bortezomib therapy in multiple myeloma: a single-center experience and review of the literature.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocol | 2007 |
Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma.
Topics: Anorexia; Antineoplastic Agents; Apoptosis; Constipation; Diarrhea; Drug Eruptions; Drug Monitoring; | 2007 |
Management of relapsed and relapsed refractory myeloma.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Trials as | 2007 |
Thalidomide in the treatment of multiple myeloma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Multip | 2007 |
Lenalidomide in multiple myeloma.
Topics: Amyloidosis; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Humans; Lenalido | 2007 |
Multiple myeloma: novel approaches for relapsed disease.
Topics: Antineoplastic Agents; Boronic Acids; Bortezomib; Clinical Trials as Topic; Humans; Lenalidomide; Mu | 2007 |
Treatment approaches for relapsing and refractory multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Disease Progression; Drug Resistance, Neoplasm; Hema | 2000 |
119 trials available for thalidomide and Local Neoplasm Recurrence
| Article | Year |
|---|---|
Isatuximab for relapsed/refractory multiple myeloma: review of key subgroup analyses from the Phase III ICARIA-MM study.
Topics: Age Factors; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols | 2021 |
A phase 2 trial of the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high-risk relapsed/refractory multiple myeloma.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Hu | 2022 |
Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma.
Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethaso | 2022 |
Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Lenal | 2022 |
Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Hu | 2022 |
Phase 2 study of oral thalidomide-cyclophosphamide-dexamethasone for recurrent/refractory adult Langerhans cell histiocytosis.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Dexamethasone; Histiocytosi | 2022 |
Alternate-day dosing of pomalidomide in relapsed/ refractory multiple myeloma: a multicenter, single-arm phase 2 trial.
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Multiple Myeloma; Neoplasm Re | 2023 |
Aponermin or placebo in combination with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma (CPT-MM301): a randomised, double-blinded, placebo-controlled, phase 3 trial.
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Multiple Myeloma; Neoplasm Re | 2023 |
Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)-a trial by the Asian Myeloma Network.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Asian People; Cyclophosphamide; Dexamethasone; | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherap | 2019 |
Association between immunosuppressive cytokines and PSA progression in biochemically recurrent prostate cancer treated with intermittent hormonal therapy.
Topics: Aged; Antineoplastic Agents, Hormonal; Biomarkers, Tumor; Cohort Studies; Cytokines; Disease Progres | 2020 |
Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.
Topics: Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Re | 2020 |
MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial.
Topics: ADP-ribosyl Cyclase 1; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplasti | 2020 |
MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial.
Topics: ADP-ribosyl Cyclase 1; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplasti | 2020 |
MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial.
Topics: ADP-ribosyl Cyclase 1; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplasti | 2020 |
MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial.
Topics: ADP-ribosyl Cyclase 1; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplasti | 2020 |
Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; | 2020 |
Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment.
Topics: Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; | 2020 |
Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemother | 2021 |
Filanesib in combination with pomalidomide and dexamethasone in refractory MM patients: safety and efficacy, and association with alpha 1-acid glycoprotein (AAG) levels. Phase Ib/II Pomdefil clinical trial conducted by the Spanish MM group.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Dexa | 2021 |
Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexameth | 2021 |
Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunologi | 2021 |
Predictive biomarkers with isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor | 2021 |
A phase II trial of continuous ixazomib, thalidomide and dexamethasone for relapsed and/or refractory multiple myeloma: the Australasian Myeloma Research Consortium (AMaRC) 16-02 trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Australia; Boron Com | 2021 |
Final results of a phase 1b study of isatuximab short-duration fixed-volume infusion combination therapy for relapsed/refractory multiple myeloma.
Topics: Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Pro | 2021 |
Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial.
Topics: Adult; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; | 2021 |
A randomized phase 3 study of ixazomib-dexamethasone versus physician's choice in relapsed or refractory AL amyloidosis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boron Compounds; Cyc | 2022 |
Isatuximab plus pomalidomide and dexamethasone in frail patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis.
Topics: Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; An | 2021 |
Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2017 |
A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Ant | 2017 |
A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Ant | 2017 |
A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Ant | 2017 |
A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Ant | 2017 |
A Phase I/II Trial of Panobinostat in Combination With Lenalidomide in Patients With Relapsed or Refractory Hodgkin Lymphoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Female; Hodgkin Disease; Humans; Hydrox | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2017 |
Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Boron Compound | 2017 |
Updated results of a phase 2 study of panobinostat combined with melphalan, thalidomide and prednisone (MPT) in relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Follow-Up St | 2018 |
The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease Progression; Dis | 2017 |
A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance).
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Female; Follow-Up Studies; Humans; Lena | 2017 |
Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boron Compounds; Chromosome Aberrations | 2017 |
Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA Phase III study design.
Topics: Adult; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Dexamethasone; Disease-Free | 2018 |
Topics: Activities of Daily Living; Acute Disease; Adalimumab; Adaptation, Physiological; Adenosine Triphosp | 2018 |
Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Central Nervous System Neopla | 2018 |
Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Central Nervous System Neopla | 2018 |
Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Central Nervous System Neopla | 2018 |
Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Central Nervous System Neopla | 2018 |
Clonal evolution in myeloma: the impact of maintenance lenalidomide and depth of response on the genetics and sub-clonal structure of relapsed disease in uniformly treated newly diagnosed patients.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Clonal Evolution; Exome Seq | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clarithromycin; Dexa | 2019 |
A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineopl | 2019 |
Clinical efficacy of daratumumab, pomalidomide, and dexamethasone in patients with relapsed or refractory myeloma: Utility of re-treatment with daratumumab among refractory patients.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protoco | 2019 |
Phase Ib dose-escalation study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Diarr | 2013 |
Phase I dose escalation study of bortezomib in combination with lenalidomide in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; | 2013 |
A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; China; Dexamethasone | 2013 |
A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; China; Dexamethasone | 2013 |
A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; China; Dexamethasone | 2013 |
A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; China; Dexamethasone | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Fema | 2013 |
Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Diarr | 2013 |
Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.
Topics: Adult; Aged; Aged, 80 and over; Disease-Free Survival; Drug Administration Schedule; Drug-Related Si | 2013 |
Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.
Topics: Adult; Aged; Aged, 80 and over; Disease-Free Survival; Drug Administration Schedule; Drug-Related Si | 2013 |
Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.
Topics: Adult; Aged; Aged, 80 and over; Disease-Free Survival; Drug Administration Schedule; Drug-Related Si | 2013 |
Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.
Topics: Adult; Aged; Aged, 80 and over; Disease-Free Survival; Drug Administration Schedule; Drug-Related Si | 2013 |
A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children with recurrent or progressive cancer.
Topics: Adolescent; Adult; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Celecoxi | 2014 |
A prospective study of lenalidomide monotherapy for relapse after Allo-SCT for multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Disease Progression; Female; Hematopoietic Stem Cell Transplan | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2014 |
Sequential ofatumumab and lenalidomide for the treatment of relapsed and refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
Topics: Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Drug Combination | 2015 |
Phase I-II trial of oral cyclophosphamide, prednisone and lenalidomide for the treatment of patients with relapsed and refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Fe | 2015 |
A phase II study of lenalidomide in platinum-sensitive recurrent ovarian carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; CA-125 Antigen; Carcinoma, Ovarian Epit | 2014 |
Clinical outcomes of a novel combination of lenalidomide and rituximab followed by stem cell transplantation for relapsed/refractory aggressive B-cell non-hodgkin lymphoma.
Topics: Aged; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols; Combin | 2014 |
Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Disease-Free Surviva | 2015 |
Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Disease-Free Surviva | 2015 |
Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Disease-Free Surviva | 2015 |
Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Disease-Free Surviva | 2015 |
Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Cross-Sectional Studies; Dexamethasone; Dose-Respons | 2015 |
Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chem | 2014 |
Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chem | 2014 |
Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chem | 2014 |
Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chem | 2014 |
Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Chromosomes, Human, | 2015 |
The impact of clone size on the prognostic value of chromosome aberrations by fluorescence in situ hybridization in multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Chromosome Aberrations; Cyclophosphamide | 2015 |
Lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma and renal impairment.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; China; Dexamethasone; Disease-Free | 2015 |
Clinical and pharmacodynamic analysis of pomalidomide dosing strategies in myeloma: impact of immune activation and cereblon targets.
Topics: Angiogenesis Inhibitors; Female; Humans; Immunohistochemistry; Kaplan-Meier Estimate; Killer Cells, | 2015 |
Clinical and pharmacodynamic analysis of pomalidomide dosing strategies in myeloma: impact of immune activation and cereblon targets.
Topics: Angiogenesis Inhibitors; Female; Humans; Immunohistochemistry; Kaplan-Meier Estimate; Killer Cells, | 2015 |
Clinical and pharmacodynamic analysis of pomalidomide dosing strategies in myeloma: impact of immune activation and cereblon targets.
Topics: Angiogenesis Inhibitors; Female; Humans; Immunohistochemistry; Kaplan-Meier Estimate; Killer Cells, | 2015 |
Clinical and pharmacodynamic analysis of pomalidomide dosing strategies in myeloma: impact of immune activation and cereblon targets.
Topics: Angiogenesis Inhibitors; Female; Humans; Immunohistochemistry; Kaplan-Meier Estimate; Killer Cells, | 2015 |
A Phase I Trial of the Anti-KIR Antibody IPH2101 and Lenalidomide in Patients with Relapsed/Refractory Multiple Myeloma.
Topics: Adrenal Cortex Hormones; Adult; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Ant | 2015 |
Lenalidomide, idelalisib, and rituximab are unacceptably toxic in patients with relapsed/refractory indolent lymphoma.
Topics: Aged; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols; Female | 2015 |
Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Disease Progression | 2015 |
Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma.
Topics: Aged; Antineoplastic Agents; Asian People; Dexamethasone; Disease-Free Survival; Female; Humans; Jap | 2015 |
Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Aspirin; Disease Pro | 2015 |
Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Aspirin; Disease Pro | 2015 |
Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Aspirin; Disease Pro | 2015 |
Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Aspirin; Disease Pro | 2015 |
Ofatumumab and Lenalidomide for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Correlation between Responses and Immune Characteristics.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineopl | 2016 |
Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; China; Dexamethasone | 2016 |
Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group.
Topics: Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Chronic Disease; Cisplatin; | 2016 |
Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial.
Topics: Aged; Angiogenesis Inhibitors; Antineoplastic Agents; Confidence Intervals; Disease-Free Survival; D | 2016 |
[Clinical Efficacy Comparison between CHOPE Regimen alone and It Combined with Thalidomide for Relapsed and Refractory Non-Hodgkin's Lymphoma].
Topics: Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Doxorubicin; Etoposide; Humans; La | 2016 |
Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantatio
Topics: Adult; Aged; Dexamethasone; Disease-Free Survival; Female; Humans; Lenalidomide; Male; Middle Aged; | 2016 |
Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial.
Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Immunologic Factors; Lenalidomide; Lymphoma, Large B | 2017 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; | 2008 |
[Bortezomib-based combination therapy for relapsed or refractory multiple myeloma].
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2008 |
Lenalidomide, adriamycin, and dexamethasone (RAD) in patients with relapsed and refractory multiple myeloma: a report from the German Myeloma Study Group DSMM (Deutsche Studiengruppe Multiples Myelom).
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease Progression; Doxorubici | 2009 |
N9986: a phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Anemia; Dose-Response Relationship, Drug; Fatigue; Female; Humans; Immunosu | 2009 |
Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Femal | 2009 |
Lenalidomide in patients with cisplatin-refractory and multiply relapsed germ cell tumors.
Topics: Adult; Antineoplastic Agents; Cisplatin; Compassionate Use Trials; Drug Resistance, Neoplasm; Humans | 2010 |
Bortezomib, doxorubicin, and dexamethasone combination therapy followed by thalidomide and dexamethasone consolidation as a salvage treatment for relapsed or refractory multiple myeloma: analysis of efficacy and safety.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Dexamethason | 2010 |
Lenalidomide, melphalan, prednisone and thalidomide (RMPT) for relapsed/refractory multiple myeloma.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease Progression; Drug R | 2010 |
Reiterative survival analyses of total therapy 2 for multiple myeloma elucidate follow-up time dependency of prognostic variables and treatment arms.
Topics: Angiogenesis Inhibitors; Follow-Up Studies; Humans; Multiple Myeloma; Neoplasm Recurrence, Local; Re | 2010 |
Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Cohort Studies; Cyc | 2010 |
Randomized phase III trial of tamoxifen versus thalidomide in women with biochemical-recurrent-only epithelial ovarian, fallopian tube or primary peritoneal carcinoma after a complete response to first-line platinum/taxane chemotherapy with an evaluation
Topics: Administration, Oral; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents, Hormo | 2010 |
An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Internatio | 2011 |
An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Internatio | 2011 |
An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Internatio | 2011 |
An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Internatio | 2011 |
Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2011 |
Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2011 |
Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2011 |
Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2011 |
Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma.
Topics: Aged; Antineoplastic Agents, Hormonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone | 2011 |
Lenalidomide can be safely combined with R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I study.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chem | 2011 |
Lenalidomide modulates IL-8 and anti-prostate antibody levels in men with biochemically recurrent prostate cancer.
Topics: Adenocarcinoma; Aged; Aged, 80 and over; Antigens, Surface; Antineoplastic Agents; Biomarkers, Tumor | 2012 |
Phase I trial of lenalidomide and CCI-779 in patients with relapsed multiple myeloma: evidence for lenalidomide-CCI-779 interaction via P-glycoprotein.
Topics: Antineoplastic Combined Chemotherapy Protocols; ATP Binding Cassette Transporter, Subfamily B; ATP B | 2011 |
Efficacy of dose-reduced lenalidomide in patients with refractory or recurrent multiple myeloma.
Topics: Aged; Antineoplastic Agents; Dose-Response Relationship, Drug; Female; Humans; Lenalidomide; Male; M | 2011 |
Phase 2 trial of irinotecan and thalidomide in adults with recurrent anaplastic glioma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Disease-Free Survival; | 2012 |
Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents, Hormonal; Dexamethas | 2012 |
A phase 2 study of pegylated liposomal doxorubicin, bortezomib, dexamethasone and lenalidomide for patients with relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2012 |
A phase 1 study of concomitant high-dose lenalidomide and 5-azacitidine induction in the treatment of AML.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Azacitid | 2013 |
A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806).
Topics: Adolescent; Adult; Angiogenesis Inhibitors; Brain Neoplasms; Chemoradiotherapy; Female; Follow-Up St | 2013 |
Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Constipation; Disease Progression; Female; Glioblastoma; Heada | 2004 |
Modifications to therapy for multiple myeloma: pegylated liposomal Doxorubicin in combination with vincristine, reduced-dose dexamethasone, and thalidomide.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Dexa | 2003 |
Effect of thalidomide therapy on bone marrow angiogenesis in multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Marrow; Dexamethasone; Humans; Microcirculation | 2004 |
Low-dose thalidomide for multiple myeloma: interim analysis of a compassionate use program.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Austria; Cyclophosphamide; Dexamethasone; Dise | 2004 |
Phase II study of thalidomide in patients with metastatic malignant melanoma.
Topics: Administration, Oral; Adult; Aged; Angiogenesis Inhibitors; Drug Administration Schedule; Female; Fi | 2004 |
Phase II trial of thalidomide for advanced and recurrent gynecologic sarcoma: a brief communication from the New York Phase II consortium.
Topics: Administration, Oral; Carcinosarcoma; Female; Genital Neoplasms, Female; Humans; Neoplasm Recurrence | 2006 |
Safety and efficacy of thalidomide in recurrent epithelial ovarian and peritoneal carcinoma.
Topics: Administration, Oral; Adult; Aged; Angiogenesis Inhibitors; California; Drug Administration Schedule | 2006 |
A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Dac | 2007 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Agents; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; Leuk | 2006 |
Safety and efficacy of lenalidomide (Revlimid) in recurrent ovarian and primary peritoneal carcinoma.
Topics: Adult; Aged; Antineoplastic Agents; Female; Humans; Lenalidomide; Middle Aged; Neoplasm Recurrence, | 2007 |
Phase II study of metronomic chemotherapy for recurrent malignant gliomas in adults.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasm | 2007 |
A phase II trial of thalidomide in patients with refractory leiomyosarcoma of the uterus and correlation with biomarkers of angiogenesis: a gynecologic oncology group study.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antigens, CD; Biomarkers, Tumor; Dose-Response Relationship, D | 2007 |
Neurotoxicity of bortezomib therapy in multiple myeloma: a single-center experience and review of the literature.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocol | 2007 |
A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Central Nervous System Neoplasms; Dose-Respon | 2007 |
A prospective randomized trial of thalidomide with topotecan compared with topotecan alone in women with recurrent epithelial ovarian carcinoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Midd | 2008 |
Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy.
Topics: Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Disease Progression; Doxo | 2008 |
Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Camptothecin; Disease- | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow; Cytokines; Female; Humans; Kaplan-Meier | 2008 |
Single-institute phase 2 study of thalidomide treatment for refractory or relapsed multiple myeloma: prognostic factors and unique toxicity profile.
Topics: Adult; Aged; Disease-Free Survival; Female; Humans; Immunosuppressive Agents; Male; Maximum Tolerate | 2008 |
Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas.
Topics: Adult; Aged; Angiogenesis Inhibitors; Biomarkers, Tumor; Chemotherapy, Adjuvant; Combined Modality T | 2000 |
Thalidomide as an anti-angiogenic agent in relapsed gliomas.
Topics: Adult; Angiogenesis Inhibitors; Brain Neoplasms; Disease Progression; Glioma; Humans; Middle Aged; N | 2001 |
Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Carcinoma, Squamous C | 2001 |
Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme.
Topics: Adult; Aged; Antineoplastic Agents; Brain Neoplasms; Disease Progression; Endothelial Growth Factors | 2001 |
130 other studies available for thalidomide and Local Neoplasm Recurrence
| Article | Year |
|---|---|
Real-Life Experience with Pomalidomide plus Low-Dose Dexamethasone in Patients with Relapsed and Refractory Multiple Myeloma: A Retrospective and Prospective Study.
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Multiple Myeloma; Neoplasm Re | 2021 |
Three Cases of Lenalidomide Therapy for Multiple Myeloma and Subsequent Development of Secondary B-ALL.
Topics: Aged; Humans; Lenalidomide; Multiple Myeloma; Neoplasm Recurrence, Local; Pancytopenia; Thalidomide | 2022 |
Outcomes of anti-CD38 isatuximab plus pomalidomide and dexamethasone in five relapsed myeloma patients with prior exposure to anti-C38 daratumumab: case series.
Topics: ADP-ribosyl Cyclase 1; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplast | 2022 |
Sequential Use of Carfilzomib and Pomalidomide in Relapsed Multiple Myeloma: A Report from the Canadian Myeloma Research Group (CMRG) Database.
Topics: Antineoplastic Combined Chemotherapy Protocols; Canada; Dexamethasone; Humans; Multiple Myeloma; Neo | 2022 |
Pomalidomide, dexamethasone, and daratumumab in Japanese patients with relapsed or refractory multiple myeloma after lenalidomide-based treatment.
Topics: Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; | 2022 |
Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Hu | 2022 |
Infections in relapsed myeloma patients treated with isatuximab plus pomalidomide and dexamethasone during the COVID-19 pandemic: Initial results of a UK-wide real-world study.
Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; COVID-19; C | 2022 |
Primary outcomes by 1q21+ status for isatuximab-treated patients with relapsed/refractory multiple myeloma: subgroup analyses from ICARIA-MM and IKEMA.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Hu | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical Trials, | 2022 |
Clonal hematopoiesis is associated with hematological toxicity during lenalidomide-based therapy for MCL.
Topics: Clonal Hematopoiesis; Hematopoiesis; Humans; Lenalidomide; Lymphoma, Mantle-Cell; Neoplasm Recurrenc | 2022 |
Assessing Pretransplant and Posttransplant Therapy Response in Multiple Myeloma Patients.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Cyclophosphamide; Dexamethasone; Humans; | 2022 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Study of a metronomic-chemotherapy regimen comprising prednisone, etoposide and procarbazine combined with thalidomide±Rituxan for relapsed refractory B-cell lymphoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Etoposide; Humans; Lymphoma, B-Cell; Neoplasm Recurr | 2023 |
Real-world assessment of treatment patterns and outcomes in patients with relapsed-refractory multiple myeloma in an Italian haematological tertiary care centre.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Lenalidomide; Multiple | 2023 |
Drug class refractoriness, not number of prior lines of therapy, properly classify patients with relapsed and refractory multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Multiple Myeloma; Neoplasm Re | 2023 |
Revisiting checkpoint inhibitors for myeloma: maintenance after stem cell transplant.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Hematopoietic Stem Cell Transplantation; Le | 2023 |
[The efficacy and safety analysis of pomalidomide in the treatment of relapsed/refractory multiple myeloma].
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Multiple Myeloma; Neoplasm Re | 2023 |
Fever, Pancytopenia, and Tender Erythematous Plaques in a Patient With Multiple Myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Erythema; Humans; Lenalidomide; Multi | 2023 |
Analysis of the Efficacy of Thalidomide Plus Dexamethasone-Based Regimens in Patients With Relapsed/Refractory Multiple Myeloma Who Received Prior Chemotherapy, Including Bortezomib and Lenalidomide: KMM-166 Study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexameth | 2020 |
Hemophagocytic relapsed intramedullary plasmacytoma.
Topics: Adult; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Bo | 2020 |
Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel Combination Treatment of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Area Under Curve; Ba | 2020 |
Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Humans; Multiple Myeloma; | 2020 |
Pomalidomide-associated progressive multifocal leukoencephalopathy in multiple myeloma: cortical susceptibility-weighted imaging hypointense findings prior to clinical deterioration.
Topics: Aged; Clinical Deterioration; Dexamethasone; Female; Humans; Immunologic Factors; JC Virus; Leukoenc | 2020 |
Isatuximab plus pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis.
Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Dexamethaso | 2021 |
Multiagent therapy with pomalidomide, bortezomib, doxorubicin, dexamethasone, and daratumumab ("Pom-PAD-Dara") in relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy | 2020 |
A Clinician's Perspective of Elotuzumab in the Treatment of Relapsed or Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials, | 2019 |
A Clinician's Perspective of Elotuzumab in the Treatment of Relapsed or Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials, | 2019 |
Immunomodulation in Pomalidomide, Dexamethasone, and Daratumumab-Treated Patients with Relapsed/Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; CD8-Positive T-Lymphocytes; | 2020 |
Thalidomide as a potential adjuvant treatment for paraneoplastic pemphigus: A single-center experience.
Topics: Humans; Neoplasm Recurrence, Local; Paraneoplastic Syndromes; Pemphigus; Prednisone; Thalidomide | 2020 |
Drug-Disease Interaction and Time-Dependent Population Pharmacokinetics of Isatuximab in Relapsed/Refractory Multiple Myeloma Patients.
Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Hormonal; An | 2020 |
Outcomes of Daratumumab, Pomalidomide, and Dexamethasone, Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation, in Patients With Relapsed/Refractory Multiple Myeloma.
Topics: Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Re | 2021 |
Recurrent or progressive pediatric brain tumors: population pharmacokinetics and exposure-response analysis of pomalidomide.
Topics: Adolescent; Antineoplastic Agents, Immunological; Brain Neoplasms; Child; Disease Progression; Dose- | 2021 |
Elotuzumab in the treatment of relapsed and refractory multiple myeloma.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Cell | 2021 |
Real-world treatment patterns, healthcare use and costs in triple-class exposed relapsed and refractory multiple myeloma patients in the USA.
Topics: Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Drug Resistance, Neopl | 2021 |
Role of MBD3-SOX2 axis in residual myeloma following pomalidomide.
Topics: Angiogenesis Inhibitors; Biomarkers, Tumor; DNA-Binding Proteins; Gene Expression Regulation, Neopla | 2021 |
Real-world treatment patterns in relapsed/refractory multiple myeloma: Clinical and economic outcomes in patients treated with pomalidomide or daratumumab.
Topics: Adult; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans | 2022 |
Immunomodulators in newly diagnosed multiple myeloma: current and future concepts.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Humans; Immunologic | 2021 |
Diagnosis and treatment of multiple myeloma in Germany: analysis of a nationwide multi-institutional survey.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Cardiova | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as T | 2017 |
Metachronous solitary plasmacytoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Cyclophosphamide; Diphosphonates; Di | 2017 |
Prolonged survival after second autologous transplantation and lenalidomide maintenance for salvage treatment of myeloma patients at first relapse after prior autograft.
Topics: Adult; Aged; Autografts; Disease-Free Survival; Humans; Lenalidomide; Maintenance Chemotherapy; Midd | 2018 |
Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical | 2018 |
Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical | 2018 |
Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical | 2018 |
Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Clinical | 2018 |
Sequential development of multifocal recurrent non-Hodgkin's lymphoma of mucosa-associated lymphoid tissue and diffuse large B-Cell lymphoma in a single patient: A case report.
Topics: Adult; Antineoplastic Agents, Immunological; Antineoplastic Combined Chemotherapy Protocols; Hematop | 2018 |
Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2018 |
[Successful Treatment with Pomalidomide, Bortezomib, and Dexamethasone in a Patient with Frail Refractory and Relapsed Multiple Myeloma with Extramedullary Disease].
Topics: Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Female | 2018 |
Extramedullary Manifestation of Multiple Myeloma in the Oral Cavity.
Topics: Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Disease Progression; Fata | 2018 |
Pomalidomide-dexamethasone for treatment of soft-tissue plasmacytomas in patients with relapsed / refractory multiple myeloma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplas | 2019 |
[Multiple myeloma treatment].
Topics: Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Humans; Multiple Myeloma; Neoplasm Recur | 2018 |
Real world Italian experience of pomalidomide plus low-dose dexamethasone in the relapsed and refractory myeloma setting: extended follow-up of a retrospective multicenter study by the 'Rete Ematologica Pugliese E Basilicata'.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug | 2019 |
Oprozomib, pomalidomide, and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Administration Sche | 2019 |
Risk factors for MDS and acute leukemia following total therapy 2 and 3 for multiple myeloma.
Topics: Acute Disease; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acid | 2013 |
Risk factors for MDS and acute leukemia following total therapy 2 and 3 for multiple myeloma.
Topics: Acute Disease; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acid | 2013 |
Risk factors for MDS and acute leukemia following total therapy 2 and 3 for multiple myeloma.
Topics: Acute Disease; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acid | 2013 |
Risk factors for MDS and acute leukemia following total therapy 2 and 3 for multiple myeloma.
Topics: Acute Disease; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acid | 2013 |
Addition of clarithromycin to lenalidomide/low-dose dexamethasone was effective in a case of relapsed myeloma after long-term use of lenalidomide.
Topics: Clarithromycin; Dexamethasone; Drug Administration Schedule; Drug Therapy, Combination; Female; Huma | 2013 |
Metronomic therapy is an effective salvage treatment for heavily pre-treated relapsed/refractory multiple myeloma.
Topics: Administration, Metronomic; Adult; Aged; Aged, 80 and over; Cisplatin; Dexamethasone; Doxorubicin; F | 2013 |
Sequence of novel agents in multiple myeloma: an instrumental variable analysis.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2013 |
The impact of upfront versus sequential use of bortezomib among patients with newly diagnosed multiple myeloma (MM): a joint analysis of the Singapore MM Study Group and the Korean MM Working Party for the Asian myeloma network.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte | 2013 |
Pomalidomide in the treatment of relapsed multiple myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Trials as Topic; | 2013 |
Efficacy and safety profile of long-term exposure to lenalidomide in patients with recurrent multiple myeloma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease Progression; Dru | 2013 |
HIF-1α of bone marrow endothelial cells implies relapse and drug resistance in patients with multiple myeloma and may act as a therapeutic target.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Bone Marrow Cells; Boronic Acids; Bortezomib; Drug R | 2014 |
Efficacy and safety of lenalinomide combined with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Topics: Aged; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols; Diseas | 2014 |
Successful multimodal treatment for aggressive metastatic and recurrent fibrolamellar hepatocellular carcinoma in a child.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Hepatocellular; Child; Cisplatin; Combine | 2014 |
Osteolytic lesions in patients with relapse of diffuse large B-cell lymphoma treated with lenalidomide.
Topics: Aged; Angiogenesis Inhibitors; Female; Humans; Lenalidomide; Lymphoma, Large B-Cell, Diffuse; Middle | 2014 |
Intermittent granulocyte colony-stimulating factor for neutropenia management in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2015 |
The successful treatment of a recurrent intracranial, dural-based plasmacytoma with lenalidomide.
Topics: Aged; Angiogenesis Inhibitors; Brain Neoplasms; Female; Humans; Lenalidomide; Neoplasm Recurrence, L | 2014 |
An alternative dosing strategy of lenalidomide for patients with relapsed multiple myeloma.
Topics: Antineoplastic Agents; Humans; Lenalidomide; Multiple Myeloma; Neoplasm Recurrence, Local; Thalidomi | 2015 |
Lenalidomide monotherapy in heavily pretreated patients with non-Hodgkin lymphoma: an Italian observational multicenter retrospective study in daily clinical practice.
Topics: Adult; Aged; Aged, 80 and over; Disease-Free Survival; Female; Humans; Immunologic Factors; Italy; L | 2015 |
Towards a chemotherapy-free approach in indolent lymphoma.
Topics: Antibodies, Monoclonal, Murine-Derived; Female; Humans; Lenalidomide; Lymphoma, Follicular; Lymphoma | 2014 |
Lenalidomide monotherapy as salvage treatment for recurrent primary CNS lymphoma.
Topics: Aged; Angiogenesis Inhibitors; Central Nervous System Neoplasms; Female; Humans; Lenalidomide; Lymph | 2015 |
"Real world" outcome of lenalidomide plus dexamethasone in the setting of recurrent and refractory multiple myeloma: extended follow-up of a retrospective multicenter study by the "rete ematologica pugliese".
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug | 2015 |
Lenalidomide in non-Hodgkin lymphoma: biological perspectives and therapeutic opportunities.
Topics: Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Drug Resistance, Neoplasm; | 2015 |
Patterns of total cost and economic consequences of progression for patients with newly diagnosed multiple myeloma.
Topics: Adult; Aged; Bortezomib; Costs and Cost Analysis; Disease Progression; Female; Humans; Lenalidomide; | 2015 |
[Carfilzomib in multiple myeloma relapses].
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Cl | 2015 |
Pooled analysis of pomalidomide for treating patients with multiple myeloma.
Topics: Angiogenesis Inhibitors; Clinical Trials as Topic; Drug Resistance, Neoplasm; Humans; Meta-Analysis | 2015 |
[Clinical observations of lenalidomide combination chemotherapy for relapsing or refractory multiple myeloma].
Topics: Antineoplastic Combined Chemotherapy Protocols; Beijing; Humans; Lenalidomide; Multiple Myeloma; Neo | 2015 |
A comparison of salvage infusional chemotherapy regimens for recurrent/refractory multiple myeloma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Cisplatin; Cyclophosphamide | 2015 |
Ischemic colitis diagnosed by magnetic resonance imaging during lenalidomide treatment in a patient with relapsed multiple myeloma.
Topics: Anti-Infective Agents; Antineoplastic Combined Chemotherapy Protocols; Colitis, Ischemic; Combined M | 2016 |
Metastasized Leydig cell tumor in a dog.
Topics: Administration, Metronomic; Angiogenesis Inhibitors; Animals; Antineoplastic Agents, Alkylating; Che | 2015 |
Safe and prolonged survival with long-term exposure to pomalidomide in relapsed/refractory myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexameth | 2016 |
Lenalidomide with low- or intermediate-dose dexamethasone in patients with relapsed or refractory myeloma.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease-Free Survival; Dose-Res | 2016 |
Haematological cancers: Lenalidomide--SPRINT to a new standard?
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; Female; Humans; Lymphoma, Mantle-Cell; Male; Neoplas | 2016 |
Haematological cancer: PomCyDex - a lower-cost option in refractory myeloma?
Topics: Humans; Multiple Myeloma; Neoplasm Recurrence, Local; Thalidomide | 2016 |
Lenalidomide is effective and safe for the treatment of patients with relapsed multiple myeloma and very severe renal impairment.
Topics: Aged; Aged, 80 and over; Cohort Studies; Fatigue; Female; Humans; Immunologic Factors; Lenalidomide; | 2016 |
Chemotherapy of mantle cell lymphoma relapsed or refractory chronic lymphocytic leukaemia.
Topics: Adenine; Antineoplastic Agents; Bendamustine Hydrochloride; Bortezomib; Chromosomes, Human, Pair 17; | 2016 |
Moving Beyond Autologous Transplantation in Multiple Myeloma: Consolidation, Maintenance, Allogeneic Transplant, and Immune Therapy.
Topics: Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Disease-Free Survival; He | 2016 |
Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Is It a Valid Treatment Option?
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Female; Humans; | 2016 |
[Clinical features and outcomes: analysis of 9 cases of HIV-negtive plasmablastic lymphoma].
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Disease-Free Survival | 2016 |
The possible role of burden of therapy on the risk of myeloma extramedullary spread.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Female; | 2017 |
Secondary primary malignancies during the lenalidomide-dexamethasone regimen in relapsed/refractory multiple myeloma patients.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Femal | 2017 |
Efficacy and toxicity of the combination chemotherapy of thalidomide, alkylating agent, and steroid for relapsed/refractory myeloma patients: a report from the Korean Multiple Myeloma Working Party (KMMWP) retrospective study.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemother | 2017 |
Pomalidomide experience: an effective therapeutic approach with immunomodulatory drugs in a patient with relapsed-refractory multiple myeloma.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Dr | 2017 |
Real-World Treatment Patterns, Time to Next Treatment, and Economic Outcomes in Relapsed or Refractory Multiple Myeloma Patients Treated with Pomalidomide or Carfilzomib.
Topics: Antineoplastic Combined Chemotherapy Protocols; Costs and Cost Analysis; Dexamethasone; Disease Prog | 2017 |
Durable clinical and cytogenetic remission in an elderly patient with relapsed acute myeloid leukemia treated with low-dose lenalidomide.
Topics: Acute Disease; Aged, 80 and over; Antimetabolites, Antineoplastic; Antineoplastic Agents; Azacitidin | 2009 |
Thalidomide in small cell lung cancer: wrong drug or wrong disease?
Topics: Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Brain Ne | 2009 |
Efficacy of lenalidomide in an sAML patient with del 5q relapsing after reduced-intensity allogeneic stem cell transplantation performed in complete remission.
Topics: Aged; Antineoplastic Agents; Chromosomes, Human, Pair 5; Female; Gene Deletion; Hematopoietic Stem C | 2010 |
Weekly topotecan and daily thalidomide in patients with recurrent epithelial ovarian cancer: a report of 2 cases.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Sch | 2009 |
Tumor flare reactions and response to lenalidomide in patients with refractory classic Hodgkin lymphoma.
Topics: Adult; Anti-Inflammatory Agents; Antineoplastic Agents; Compassionate Use Trials; Hodgkin Disease; H | 2010 |
Total Therapy 3 for multiple myeloma: prognostic implications of cumulative dosing and premature discontinuation of VTD maintenance components, bortezomib, thalidomide, and dexamethasone, relevant to all phases of therapy.
Topics: Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Boronic Acids; Bortezomib; Dexame | 2010 |
Lenalidomide induced good clinical response in a patient with multiple relapsed and refractory Hodgkin's lymphoma.
Topics: Adult; Antineoplastic Agents; Drug Resistance, Neoplasm; Female; Hodgkin Disease; Humans; Lenalidomi | 2010 |
Rituximab-lenalidomide-dexamethasone induces complete and durable remission in relapsed refractory diffuse large B-cell non-Hodgkin lymphoma.
Topics: Aged; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols; Dexame | 2010 |
No influence of the polymorphisms CYP2C19 and CYP2D6 on the efficacy of cyclophosphamide, thalidomide, and bortezomib in patients with Multiple Myeloma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Aryl Hydrocarbon Hydroxylases; Boronic | 2010 |
Treatment of patients with relapsed/refractory multiple myeloma with lenalidomide and dexamethasone with or without bortezomib: prospective evaluation of the impact of cytogenetic abnormalities and of previous therapies.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Chromosome Aberrati | 2010 |
Novel agents improve survival of transplant patients with multiple myeloma including those with high-risk disease defined by early relapse (<12 months).
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Combined Mod | 2011 |
Primary plasma cell leukemia: a retrospective multicenter study of 73 patients.
Topics: Adult; Aged; Aged, 80 and over; Anthracyclines; Antineoplastic Combined Chemotherapy Protocols; Boro | 2011 |
Optimizing the use of lenalidomide in relapsed or refractory multiple myeloma: consensus statement.
Topics: Antineoplastic Agents; Drug Resistance, Neoplasm; Humans; Lenalidomide; Multiple Myeloma; Neoplasm R | 2011 |
Lenalidomide targets clonogenic side population in multiple myeloma: pathophysiologic and clinical implications.
Topics: Angiogenesis Inhibitors; Antineoplastic Agents; ATP-Binding Cassette Transporters; Bone Marrow Cells | 2011 |
Previous thalidomide therapy may not affect lenalidomide response and outcome in relapse or refractory multiple myeloma patients.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2011 |
Single nucleotide polymorphisms in the promoter region of the IL1B gene influence outcome in multiple myeloma patients treated with high-dose chemotherapy independently of relapse treatment with thalidomide and bortezomib.
Topics: Antineoplastic Agents; Biomarkers, Tumor; Boronic Acids; Bortezomib; Denmark; Female; Genetic Associ | 2011 |
Effective use of thalidomide in the treatment of recurrent metastatic chordoma.
Topics: Antineoplastic Agents; Bone Neoplasms; Chordoma; Humans; Male; Middle Aged; Neoplasm Recurrence, Loc | 2011 |
Lenalidomide proved effective in multisystem Langerhans cell histiocytosis.
Topics: Adult; Antineoplastic Agents; Histiocytosis, Langerhans-Cell; Humans; Lenalidomide; Male; Neoplasm R | 2012 |
Treatment for recurrent medulloblastoma with intrathecal liposomal cytarabine and systemic metronomic combination therapy.
Topics: Administration, Metronomic; Adolescent; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2012 |
Low incidence of thromboembolism in relapsed/refractory myeloma patients treated with thalidomide without thromboprophylaxis in Taiwan.
Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Cohort Studies; Dexamethasone; Drug Resist | 2012 |
Total cost comparison in relapsed/refractory multiple myeloma.
Topics: Antineoplastic Agents; Boronic Acids; Bortezomib; Dexamethasone; Fees, Pharmaceutical; Health Expend | 2013 |
Thalidomide paradoxical effect on concomitant multiple myeloma and myelodysplasia.
Topics: Acute Disease; Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; B | 2002 |
Transplantation as salvage therapy for high-risk patients with myeloma in relapse.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow Tr | 2002 |
Transplantation as salvage therapy for high-risk patients with myeloma in relapse.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow Tr | 2002 |
Transplantation as salvage therapy for high-risk patients with myeloma in relapse.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow Tr | 2002 |
Transplantation as salvage therapy for high-risk patients with myeloma in relapse.
Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow Tr | 2002 |
Interferon alfa-2a in recurrent metastatic hemangiopericytoma.
Topics: Adolescent; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; | 2003 |
Thalidomide therapy induces response in relapsed mantle cell lymphoma.
Topics: Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Drug Resistance, Neop | 2003 |
Low dose thalidomide in patients with relapsed or refractory multiple myeloma.
Topics: Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Cy | 2003 |
Recurrent multicentric glioblastoma multiforme responds to thalidomide and chemotherapy.
Topics: Adult; Antineoplastic Agents; Glioblastoma; Humans; Male; Neoplasm Recurrence, Local; Thalidomide; T | 2002 |
An evaluation of factors predicting long-term response to thalidomide in 234 patients with relapsed or resistant multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Albumins; beta 2-Microglobulin; Drug Resistance, Neoplasm; Female; H | 2004 |
Single-agent thalidomide induces response in T-cell lymphoma.
Topics: Aged; Aged, 80 and over; Female; Humans; Immunosuppressive Agents; Lymphoma, T-Cell; Male; Middle Ag | 2005 |
[Multiple myeloma -- therapy].
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Boronic Acids; Bortezomib; Combined | 2005 |
Pulmonary hypertension related to thalidomide therapy in refractory multiple myeloma.
Topics: Angiogenesis Inhibitors; Female; Humans; Hypertension, Pulmonary; Middle Aged; Multiple Myeloma; Neo | 2005 |
Velcade, Doxil and Thalidomide (VDT) is an effective salvage regimen for patients with relapsed and refractory multiple myeloma.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Doxorubicin; Female | 2005 |
Activity of thalidomide in patients with platinum-refractory germ-cell tumours.
Topics: Adult; Antineoplastic Agents; Drug Resistance, Neoplasm; Gonadal Disorders; Humans; Mediastinal Neop | 2006 |
Nonsecretory primary plasma cell leukemia with good response to thalidomide-based treatment.
Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Fatal Outcome; Humans; | 2007 |
Thalidomide-induced reversible interstitial pneumonitis in a patient with recurrent ovarian cancer.
Topics: Angiogenesis Inhibitors; Female; Humans; Lung Diseases, Interstitial; Middle Aged; Neoplasm Recurren | 2008 |
Treatment for elderly patients with multiple myeloma.
Topics: Antineoplastic Agents; Boronic Acids; Bortezomib; Humans; Multiple Myeloma; Neoplasm Recurrence, Loc | 2008 |
Higher doses of lenalidomide are associated with unacceptable toxicity including life-threatening tumor flare in patients with chronic lymphocytic leukemia.
Topics: Adult; Antineoplastic Agents; Apoptosis; Dose-Response Relationship, Drug; Flow Cytometry; Humans; L | 2008 |
Thalidomide-induced perioral neuropathy.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Breast Neoplasms; Chemotherapy, Adju | 1997 |
Dynamic contrast-enhanced T2-weighted MR imaging of recurrent malignant gliomas treated with thalidomide and carboplatin.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Carboplatin; Echo-Plan | 2000 |
Thalidomide for malignant melanoma.
Topics: Humans; Male; Melanoma; Middle Aged; Neoplasm Recurrence, Local; Skin Neoplasms; Thalidomide | 2001 |
Thalidomide in refractory and relapsing multiple myeloma.
Topics: Adult; Aged; Angiogenesis Inhibitors; Female; Humans; Male; Middle Aged; Multiple Myeloma; Neoplasm | 2001 |