thalidomide has been researched along with Neutropenia in 96 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
Neutropenia: A decrease in the number of NEUTROPHILS found in the blood.
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"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) |
" On May 30, 2020, a marketing authorization valid through the European Union (EU) was issued for isatuximab in combination with pomalidomide and dexamethasone (IsaPd) for the treatment of adult patients with relapsed and refractory (RR) multiple myeloma (MM)." | 9.41 | EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma. ( Delgado, J; Enzmann, H; Gisselbrecht, C; Moreau, A; Pignatti, F; van Hennik, PB; Zienowicz, M, 2021) |
"Patients with multiple myeloma that was refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor were randomly assigned to receive elotuzumab plus pomalidomide and dexamethasone (elotuzumab group) or pomalidomide and dexamethasone alone (control group)." | 9.27 | Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. ( Dimopoulos, MA; Dytfeld, D; Grosicki, S; Hori, M; Jou, YM; LeBlanc, R; Leleu, X; Moreau, P; Popa McKiver, M; Raab, MS; Rafferty, B; Richardson, PG; Robbins, M; San-Miguel, J; Shelat, SG; Suzuki, K; Takezako, N, 2018) |
"Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)." | 9.24 | Lenalidomide Maintenance Compared With Placebo in Responding Elderly Patients With Diffuse Large B-Cell Lymphoma Treated With First-Line Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. ( Bosly, A; Bouabdallah, R; Briere, J; Caballero, D; Cabeçadas, J; Casasnovas, RO; Catalano, J; Choufi, B; Cohen, AM; Coiffier, B; Corront, B; Fruchart, C; Gaulard, P; Gomes da Silva, M; Gonzalez, H; Greil, R; Grosicka, A; Haioun, C; Lazarovici, J; Lopez-Guillermo, A; Morschhauser, F; Oberic, L; Perrot, A; Salles, G; Sebban, C; Thieblemont, C; Tilly, H; Trotman, J; van Eygen, K; Van Hoof, A, 2017) |
"The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM)." | 9.24 | Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. ( Chen, G; Chen, WM; Eom, HS; Ervin-Haynes, A; Facon, T; Huang, SY; Hulin, C; Kim, HJ; Kim, K; Kwak, JY; Lee, JH; Lee, JJ; Lee, JO; Liu, T; Lu, J; Min, CK; Qiu, L; Shen, ZX; Yiu, W; Yoon, SS, 2017) |
" Of 13 assessable patients (nine with adult T-cell leukaemia-lymphoma, four with other peripheral T-cell lymphomas) receiving lenalidomide, dose-limiting toxic effects were reported in three patients during cycle 1 (one grade 4 thrombocytopenia [cohort 2], one grade 3 QT prolongation on electrocardiogram [cohort 3], and one grade 3 fatigue and grade 4 thrombocytopenia [cohort 3])." | 9.22 | Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study. ( Aoki, T; Asou, N; Chen, N; Choi, I; Imaizumi, Y; Maruyama, D; Midorikawa, S; Nosaka, K; Ogura, M; Ohtsu, T; Taguchi, J; Tobinai, K; Tsukasaki, K; Uchida, T; Uike, N; Utsunomiya, A, 2016) |
"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) |
"Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation." | 9.19 | Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. ( Benevolo, G; Boccadoro, M; Bringhen, S; Cavo, M; Di Raimondo, F; Falcone, AP; Franceschini, L; Gaidano, G; Gottardi, D; Grasso, M; Guglielmelli, T; Larocca, A; Levi, A; Magarotto, V; Marasca, R; Mina, R; Montefusco, V; Morabito, F; Musto, P; Nozzoli, C; Offidani, M; Omedé, P; Palumbo, A; Passera, R; Patriarca, F; Petrucci, MT; Ria, R; Rossi, D; Vincelli, ID; Zambello, R, 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) |
"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) |
"Here we report the efficacy, safety and health-related quality-of-life (HRQoL) associated with long-term lenalidomide and dexamethasone (Len + Dex) treatment in patients with relapsed or refractory multiple myeloma (RRMM) enrolled in the Spanish cohort of the MM-018 study." | 9.16 | Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience. ( Aguado, B; Alegre, A; Cibeira, MT; Garcia-Larana, J; Knight, R; Martinez-Chamorro, C; Mateos, MV; Oriol-Rocafiguera, A; Rosettani, B; Sureda, A, 2012) |
"The combination of melphalan, prednisone and thalidomide (MPT) has demonstrated efficacy and acceptable toxicity in newly diagnosed and relapsed/refractory patients with multiple myeloma (MM)." | 9.16 | Phase II study of melphalan, thalidomide and prednisone combined with oral panobinostat in patients with relapsed/refractory multiple myeloma. ( Alesiani, F; Ballanti, S; Boccadoro, M; Caraffa, P; Catarini, M; Cavallo, F; Corvatta, L; Gentili, S; Leoni, P; Liberati, AM; Offidani, M; Palumbo, A; Polloni, C; Pulini, S, 2012) |
"Lenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma." | 9.16 | Continuous lenalidomide treatment for newly diagnosed multiple myeloma. ( Beksac, M; Ben Yehuda, D; Bladé, J; Cascavilla, N; Catalano, J; Cavo, M; Corso, A; Delforge, M; Dimopoulos, MA; Gisslinger, H; Hajek, R; Herbein, L; Iosava, G; Jacques, C; Kloczko, J; Kropff, M; Langer, C; Mei, J; Palumbo, A; Petrucci, MT; Plesner, T; Radke, J; Spicka, I; Weisel, K; Wiktor-Jędrzejczak, W; Yu, Z; Zodelava, M, 2012) |
"The combination of lenalidomide and low-dose dexamethasone is an effective treatment for multiple myeloma (MM)." | 9.15 | Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma: results from a phase 2 trial. ( Allred, J; Bergsagel, PL; Buadi, FK; Dingli, D; Dispenzieri, A; Fonseca, R; Gertz, MA; Greipp, PR; Hayman, SR; Kumar, SK; Lacy, MQ; Laumann, K; Lust, JA; Mikhael, JR; Rajkumar, SV; Reeder, CB; Russell, SJ; Stewart, K; Witzig, TE; Zeldenrust, SR, 2011) |
"Initial analysis of the combination melphalan, prednisone, plus lenalidomide (MPR) showed significant antimyeloma activity in patients with untreated multiple myeloma, with neutropenia and thrombocytopenia as the most frequent side effects." | 9.14 | Melphalan, prednisone, and lenalidomide for newly diagnosed myeloma: kinetics of neutropenia and thrombocytopenia and time-to-event results. ( Benevolo, G; Boccadoro, M; Canepa, L; Falco, P; Falcone, A; Gay, F; Gozzetti, A; Knight, RD; Larocca, A; Luraschi, A; Magarotto, V; Morabito, F; Nozza, A; Palumbo, A; Petrucci, MT; Zeldis, JB, 2009) |
"A randomized phase III trial compared standard MP with MP-T (thalidomide 200 mg/d) in newly diagnosed patients with multiple myeloma older than age 65 years." | 9.14 | Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study. ( Ammerlaan, R; Lokhorst, H; Schaafsma, M; Sinnige, H; Sonneveld, P; Termorshuizen, F; van der Griend, R; van Marwijk Kooy, M; Wijermans, P; Wittebol, S; Zweegman, S, 2010) |
"A major limitation to the treatment of multiple myeloma by the thalidomide analogue CC-4047 (Actimid) is the development of a severe neutropenia." | 9.12 | The neutropenia induced by the thalidomide analogue CC-4047 in patients with multiple myeloma is associated with an increased percentage of neutrophils bearing CD64. ( Brown, KA; Macey, MG; McCarthy, DA; Schey, SA; Streetly, M, 2006) |
"Recent reports have shown that thalidomide has antiangiogenic activity and is effective for the treatment of refractory multiple myeloma." | 9.11 | Thalidomide-induced severe neutropenia during treatment of multiple myeloma. ( Hattori, Y; Ikeda, Y; Kakimoto, T; Okamoto, S; Sato, N, 2004) |
"Lenalidomide has hematologic activity in patients with low-risk myelodysplastic syndromes who have no response to erythropoietin or who are unlikely to benefit from conventional therapy." | 9.11 | Efficacy of lenalidomide in myelodysplastic syndromes. ( Buresh, A; Fuchs, D; Heaton, R; Knight, R; Kurtin, S; List, A; Mahadevan, D; Rimsza, L; Roe, DJ; Zeldis, JB, 2005) |
"In a randomized, placebo-controlled, double-blind trial, thalidomide or placebo together with glucocorticoids and either cyclosporine or tacrolimus was administered as initial therapy for clinical extensive chronic graft-versus-host disease (cGVHD)." | 9.09 | Thalidomide for treatment of patients with chronic graft-versus-host disease. ( Anasetti, C; Appelbaum, FR; Deeg, HJ; Flowers, ME; Koc, S; Leisenring, W; Martin, PJ; Nash, RA; Sanders, JE; Storb, R; Witherspoon, RP, 2000) |
"Thalidomide has been reported to be an effective agent for treatment of chronic graft-versus-host disease (CGVHD)." | 9.08 | Thalidomide as salvage therapy for chronic graft-versus-host disease. ( Blume, KG; Chao, N; Forman, SJ; Kashyap, A; Long, GD; Margolin, K; Molina, A; Nademanee, A; Negrin, RS; Niland, JC; O'Donnell, MR; Parker, PM; Planas, I; Schmidt, GM; Smith, EP; Snyder, DS; Somlo, G; Spielberger, R; Stein, AS; Stepan, DE; Wilsman, K; Zwingenberger, K, 1995) |
"In this report, a panel of European myeloma experts discuss the role of pomalidomide in the treatment of relapsed and refractory multiple myeloma (RRMM)." | 8.90 | Expert panel consensus statement on the optimal use of pomalidomide in relapsed and refractory multiple myeloma. ( Cavo, M; Davies, FE; Delforge, M; Dimopoulos, MA; Facon, T; Hansson, M; Leleu, X; Ludwig, H; Mateos, MV; Miguel, JF; Moreau, P; Morgan, GJ; Palumbo, A; Schey, SA; Sonneveld, P; Weisel, K; Zweegman, S, 2014) |
"The introduction of new agents in the treatment of multiple myeloma, such as thalidomide, bortezomib, or lenalidomide, has represented an important step forward in the management of this disease, with improvement in both treatment response and patient survival." | 8.87 | Management of the adverse effects of lenalidomide in multiple myeloma. ( González Rodríguez, AP, 2011) |
"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) |
"Lenalidomide was approved in Japan for the treatment of patients with myelodysplastic syndromes associated with a 5q deletion (del 5q-MDS) in August 2010." | 8.31 | Lenalidomide treatment of Japanese patients with myelodysplastic syndromes with 5q deletion: a post-marketing surveillance study. ( Aoki, Y; Minehata, K; Motegi, Y; Uno, S, 2023) |
"Determinants of the efficacy and safety of pomalidomide (POM) monotherapy or POM plus dexamethasone (DEX) (POM/DEX) for relapsed and refractory multiple myeloma (RRMM) were examined retrospectively in a real-world clinical practice setting in Japan." | 7.88 | Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum. ( Fuchida, SI; Hino, M; Iida, M; Imada, K; Ishikawa, J; Kamitsuji, Y; Kanakura, Y; Kaneko, H; Kobayashi, M; Kosugi, S; Kuroda, J; Matsuda, M; Matsui, T; Matsumura, I; Matsumura-Kimoto, Y; Nakaya, A; Nomura, S; Ohta, K; Shibayama, H; Shimazaki, C; Takaori-Kondo, A; Tanaka, H; Uchiyama, H; Uoshima, N; Wada, K; Yagi, H; Yokota, I, 2018) |
"Neutropenia is a well-known dose-limiting toxicity associated with lenalidomide plus dexamethasone treatment in patients with multiple myeloma; however, little is known about its management and associated outcomes in the real world setting." | 7.83 | An international, multicenter, prospective, observational study of neutropenia in patients being treated with lenalidomide + dexamethasone for relapsed or relapsed/refractory multiple myeloma (RR-MM). ( Cooney, J; Gray, D; Greil, R; Leleu, X; Minarik, J; O'Gorman, P; Sanz, RG; Szabo, Z; Terpos, E; Williams, C, 2016) |
"In order to evaluate the main adverse effects of drug protocols using bortezomib and/or thalidomide for the treatment of multiple myeloma, we conducted a prospective study." | 7.83 | Pharmacovigilance of patients with multiple myeloma being treated with bortezomib and/or thalidomide. ( Atalla, A; Castro, TB; Hallack Neto, AE; Ribeiro, LC, 2016) |
"Neutropenia may develop as an adverse event in patients with multiple myeloma receiving lenalidomide (LEN) plus dexamethasone (DEX) therapy." | 7.83 | Risk factors for neutropenia with lenalidomide plus dexamethasone therapy for multiple myeloma. ( Kimura, M; Kokuryou, T; Matsuoka, T; Mitani, Y; Nakao, T; Okada, K; Usami, E; Yamakawa, M; Yoshimura, T, 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) |
"The combination of lenalidomide, bortezomib and dexamethasone (RVD) has shown excellent efficacy in patients with relapsed or refractory multiple myeloma (RRMM)." | 7.79 | Lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone for heavily pretreated relapsed or refractory multiple myeloma. ( Chen, C; Jimenez-Zepeda, VH; Kukreti, V; Reece, DE; Tiedemann, R; Trudel, S, 2013) |
"Lenalidomide combined with dexamethasone has significant clinical activity in the treatment of multiple myeloma (MM)." | 7.74 | Should prophylactic granulocyte-colony stimulating factor be used in multiple myeloma patients developing neutropenia under lenalidomide-based therapy? ( Colado, E; García-Sanz, R; Mateos, MV; Olazábal, J; San-Miguel, J, 2008) |
"To report thrombocytopenia in a patient prescribed thalidomide for multiple myeloma (MM)." | 7.73 | Thalidomide-associated thrombocytopenia. ( Brouwers, JR; Duyvendak, M; Kingma, BJ; Naunton, M, 2005) |
" Continous high dosing schedules are poorly tolerated and minimally active." | 6.84 | A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher-risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia. ( Carraway, HE; DeZern, A; Gojo, I; Gore, SD; Smith, BD; Zeidan, AM, 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." | 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 was given orally 21/28 days per cycle for 1 year, at escalated dose of 15 to 20 mg during phase 1 to determine the MTD; the phase 2 part was conducted at the MTD." | 6.80 | Lenalidomide is safe and active in Waldenström macroglobulinemia. ( Arnulf, B; Bakala, J; Banos, A; Bories, C; Brice, P; Choquet, S; Demarquette, H; Dib, M; Fouquet, G; Guidez, S; Herbaux, C; Karlin, L; Leblond, V; LeGouill, S; Leleu, X; Louni, C; Martin, A; Morel, P; Nudel, M; Ohyba, B; Petillon, MO; Poulain, S; Salles, G; Thielemans, B; Tournilhac, O, 2015) |
" A total of 43 patients were recruited into three CPT plus thalidomide cohorts based on CPT dosage in sequence: 5 mg/kg (n = 11), 8 mg/kg (n = 17), and 10 mg/kg (n = 15)." | 6.79 | A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma. ( Chen, WM; Geng, C; Hou, J; Huang, Z; Ke, X; Liu, Y; Qiu, L; Wang, F; Wang, Z; Wei, N; Wei, P; Xi, H; Yang, S; Zhao, Y; Zheng, X; Zhu, B, 2014) |
"Lenalidomide was generally well tolerated and no grade 4 hematologic toxicities were noted." | 6.75 | Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis. ( Baz, R; Chanan-Khan, AA; Finley-Oliver, E; Hussein, MA; Lebovic, D; Lee, K; Miller, KC; Patel, M; Sher, T; Wood, M, 2010) |
"Neutropenia was a dose limiting factor with half of the cases (7/14) presenting with severe neutropenia (grade 3-4), but a response was observed in all of them on administration of G-CSF." | 6.71 | [Single-agent thalidomide for advanced and refractory multiple myeloma]. ( Fujimura, K; Imagawa, J; Katayama, Y; Kimura, A; Noda, M; Okikawa, Y; Okita, H; Sakai, A; Takimoto, Y, 2003) |
"Lenalidomide has multifaceted antimyeloma properties, including direct tumoricidal and immunomodulatory effects." | 6.55 | Lenalidomide in combination or alone as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma: a review of options for and against. ( Anderson, KC; Attal, M; Holstein, SA; McCarthy, PL; Richardson, PG; Schlossman, RL, 2017) |
"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) |
"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) |
" On May 30, 2020, a marketing authorization valid through the European Union (EU) was issued for isatuximab in combination with pomalidomide and dexamethasone (IsaPd) for the treatment of adult patients with relapsed and refractory (RR) multiple myeloma (MM)." | 5.41 | EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma. ( Delgado, J; Enzmann, H; Gisselbrecht, C; Moreau, A; Pignatti, F; van Hennik, PB; Zienowicz, M, 2021) |
"Lenalidomide was well tolerated in intensively pretreated and elderly MM patients, including those with RI." | 5.38 | Prognostic risk factor evaluation in patients with relapsed or refractory multiple myeloma receiving lenalidomide treatment: analysis of renal function by eGFR and of additional comorbidities by comorbidity appraisal. ( Engelhardt, M; Ihorst, G; Kleber, M; Koch, B; Udi, J; Wäsch, R, 2012) |
"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) |
"Patients with multiple myeloma that was refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor were randomly assigned to receive elotuzumab plus pomalidomide and dexamethasone (elotuzumab group) or pomalidomide and dexamethasone alone (control group)." | 5.27 | Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. ( Dimopoulos, MA; Dytfeld, D; Grosicki, S; Hori, M; Jou, YM; LeBlanc, R; Leleu, X; Moreau, P; Popa McKiver, M; Raab, MS; Rafferty, B; Richardson, PG; Robbins, M; San-Miguel, J; Shelat, SG; Suzuki, K; Takezako, N, 2018) |
"Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)." | 5.24 | Lenalidomide Maintenance Compared With Placebo in Responding Elderly Patients With Diffuse Large B-Cell Lymphoma Treated With First-Line Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. ( Bosly, A; Bouabdallah, R; Briere, J; Caballero, D; Cabeçadas, J; Casasnovas, RO; Catalano, J; Choufi, B; Cohen, AM; Coiffier, B; Corront, B; Fruchart, C; Gaulard, P; Gomes da Silva, M; Gonzalez, H; Greil, R; Grosicka, A; Haioun, C; Lazarovici, J; Lopez-Guillermo, A; Morschhauser, F; Oberic, L; Perrot, A; Salles, G; Sebban, C; Thieblemont, C; Tilly, H; Trotman, J; van Eygen, K; Van Hoof, A, 2017) |
"The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM)." | 5.24 | Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. ( Chen, G; Chen, WM; Eom, HS; Ervin-Haynes, A; Facon, T; Huang, SY; Hulin, C; Kim, HJ; Kim, K; Kwak, JY; Lee, JH; Lee, JJ; Lee, JO; Liu, T; Lu, J; Min, CK; Qiu, L; Shen, ZX; Yiu, W; Yoon, SS, 2017) |
" Of 13 assessable patients (nine with adult T-cell leukaemia-lymphoma, four with other peripheral T-cell lymphomas) receiving lenalidomide, dose-limiting toxic effects were reported in three patients during cycle 1 (one grade 4 thrombocytopenia [cohort 2], one grade 3 QT prolongation on electrocardiogram [cohort 3], and one grade 3 fatigue and grade 4 thrombocytopenia [cohort 3])." | 5.22 | Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study. ( Aoki, T; Asou, N; Chen, N; Choi, I; Imaizumi, Y; Maruyama, D; Midorikawa, S; Nosaka, K; Ogura, M; Ohtsu, T; Taguchi, J; Tobinai, K; Tsukasaki, K; Uchida, T; Uike, N; Utsunomiya, A, 2016) |
"The Intergroupe Francophone du Myélome conducted a randomized trial to compare bortezomib-thalidomide-dexamethasone (VTD) with bortezomib-cyclophosphamide-dexamethasone (VCD) as induction before high-dose therapy and autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma." | 5.22 | VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial. ( Allangba, O; Araujo, C; Attal, M; Avet-Loiseau, H; Belhadj, K; Biron, L; Brechignac, S; Caillon, H; Caillot, D; Chaleteix, C; Chaoui, D; Dejoie, T; Dib, M; Dorvaux, V; Eisenmann, JC; Escoffre, M; Facon, T; Fermand, JP; Fontan, J; Garderet, L; Glaisner, S; Godmer, P; Hulin, C; Jaccard, A; Kolb, B; Laribi, K; Lenain, P; Luycx, O; Macro, M; Malfuson, JV; Marit, G; Moreau, P; Pegourie, B; Planche, L; Puyade, M; Rodon, P; Roussel, M; Royer, B; Slama, B; Stoppa, AM; Tiab, M; Wetterwald, M, 2016) |
"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) |
"Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation." | 5.19 | Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. ( Benevolo, G; Boccadoro, M; Bringhen, S; Cavo, M; Di Raimondo, F; Falcone, AP; Franceschini, L; Gaidano, G; Gottardi, D; Grasso, M; Guglielmelli, T; Larocca, A; Levi, A; Magarotto, V; Marasca, R; Mina, R; Montefusco, V; Morabito, F; Musto, P; Nozzoli, C; Offidani, M; Omedé, P; Palumbo, A; Passera, R; Patriarca, F; Petrucci, MT; Ria, R; Rossi, D; Vincelli, ID; Zambello, R, 2014) |
"This open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma." | 5.19 | Autologous transplantation and maintenance therapy in multiple myeloma. ( Ben Yehuda, D; Boccadoro, M; Cafro, A; Caravita, T; Carella, AM; Catalano, L; Cavallo, F; Cavo, M; Cerrato, C; Ciccone, G; Corradini, P; Crippa, C; Di Raimondo, F; Evangelista, A; Gay, F; Genuardi, M; Marcatti, M; Musto, P; Nagler, A; Offidani, M; Omedé, P; Palumbo, A; Patriarca, F; Petrucci, MT; Pezzatti, S; Ribakovsky, E; Zamagni, E, 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) |
"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) |
"Here we report the efficacy, safety and health-related quality-of-life (HRQoL) associated with long-term lenalidomide and dexamethasone (Len + Dex) treatment in patients with relapsed or refractory multiple myeloma (RRMM) enrolled in the Spanish cohort of the MM-018 study." | 5.16 | Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience. ( Aguado, B; Alegre, A; Cibeira, MT; Garcia-Larana, J; Knight, R; Martinez-Chamorro, C; Mateos, MV; Oriol-Rocafiguera, A; Rosettani, B; Sureda, A, 2012) |
"The combination of melphalan, prednisone and thalidomide (MPT) has demonstrated efficacy and acceptable toxicity in newly diagnosed and relapsed/refractory patients with multiple myeloma (MM)." | 5.16 | Phase II study of melphalan, thalidomide and prednisone combined with oral panobinostat in patients with relapsed/refractory multiple myeloma. ( Alesiani, F; Ballanti, S; Boccadoro, M; Caraffa, P; Catarini, M; Cavallo, F; Corvatta, L; Gentili, S; Leoni, P; Liberati, AM; Offidani, M; Palumbo, A; Polloni, C; Pulini, S, 2012) |
"Lenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma." | 5.16 | Continuous lenalidomide treatment for newly diagnosed multiple myeloma. ( Beksac, M; Ben Yehuda, D; Bladé, J; Cascavilla, N; Catalano, J; Cavo, M; Corso, A; Delforge, M; Dimopoulos, MA; Gisslinger, H; Hajek, R; Herbein, L; Iosava, G; Jacques, C; Kloczko, J; Kropff, M; Langer, C; Mei, J; Palumbo, A; Petrucci, MT; Plesner, T; Radke, J; Spicka, I; Weisel, K; Wiktor-Jędrzejczak, W; Yu, Z; Zodelava, M, 2012) |
"The combination of lenalidomide and low-dose dexamethasone is an effective treatment for multiple myeloma (MM)." | 5.15 | Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma: results from a phase 2 trial. ( Allred, J; Bergsagel, PL; Buadi, FK; Dingli, D; Dispenzieri, A; Fonseca, R; Gertz, MA; Greipp, PR; Hayman, SR; Kumar, SK; Lacy, MQ; Laumann, K; Lust, JA; Mikhael, JR; Rajkumar, SV; Reeder, CB; Russell, SJ; Stewart, K; Witzig, TE; Zeldenrust, SR, 2011) |
"Lenalidomide produces unexpected but clinically significant acute anemia in patients with WM." | 5.14 | Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. ( Anderson, KC; Baron, AD; Branagan, AR; Chu, L; Hunter, ZR; Hyman, PM; Ioakimidis, L; Kash, JJ; Munshi, NC; Musto, P; Nawfel, EL; Nunnink, JC; Patterson, CJ; Sharon, DJ; Soumerai, JD; Terjanian, TO; Treon, SP, 2009) |
"Initial analysis of the combination melphalan, prednisone, plus lenalidomide (MPR) showed significant antimyeloma activity in patients with untreated multiple myeloma, with neutropenia and thrombocytopenia as the most frequent side effects." | 5.14 | Melphalan, prednisone, and lenalidomide for newly diagnosed myeloma: kinetics of neutropenia and thrombocytopenia and time-to-event results. ( Benevolo, G; Boccadoro, M; Canepa, L; Falco, P; Falcone, A; Gay, F; Gozzetti, A; Knight, RD; Larocca, A; Luraschi, A; Magarotto, V; Morabito, F; Nozza, A; Palumbo, A; Petrucci, MT; Zeldis, JB, 2009) |
" These included Grade 3 neutropenia precluding planned paclitaxel therapy (n = 3), grade 3 gastrointestinal toxicity (n = 2), chest pain (n = 1) and pulmonary embolism (n = 1)." | 5.14 | A modular Phase I study of lenalidomide and paclitaxel in metastatic castration-resistant prostate cancer following prior taxane therapy. ( Bekele, NB; Carter, CM; Mathew, P; Pagliaro, L; Tannir, N; Tu, SM, 2010) |
"A randomized phase III trial compared standard MP with MP-T (thalidomide 200 mg/d) in newly diagnosed patients with multiple myeloma older than age 65 years." | 5.14 | Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study. ( Ammerlaan, R; Lokhorst, H; Schaafsma, M; Sinnige, H; Sonneveld, P; Termorshuizen, F; van der Griend, R; van Marwijk Kooy, M; Wijermans, P; Wittebol, S; Zweegman, S, 2010) |
"A major limitation to the treatment of multiple myeloma by the thalidomide analogue CC-4047 (Actimid) is the development of a severe neutropenia." | 5.12 | The neutropenia induced by the thalidomide analogue CC-4047 in patients with multiple myeloma is associated with an increased percentage of neutrophils bearing CD64. ( Brown, KA; Macey, MG; McCarthy, DA; Schey, SA; Streetly, M, 2006) |
"Data on 72 patients receiving lenalidomide/dexamethasone for multiple myeloma (MM) was used to determine the factors that are associated with lenalidomide-induced myelosuppression." | 5.12 | Lenalidomide-induced myelosuppression is associated with renal dysfunction: adverse events evaluation of treatment-naïve patients undergoing front-line lenalidomide and dexamethasone therapy. ( Chen-Kiang, S; Christos, PJ; Coleman, M; Ely, S; Furst, JR; Jalbrzikowski, J; Jayabalan, D; Lent, R; Leonard, JP; Mark, T; Mazumdar, M; Naib, T; Niesvizky, R; Pearse, RN; Zafar, F, 2007) |
"Recent reports have shown that thalidomide has antiangiogenic activity and is effective for the treatment of refractory multiple myeloma." | 5.11 | Thalidomide-induced severe neutropenia during treatment of multiple myeloma. ( Hattori, Y; Ikeda, Y; Kakimoto, T; Okamoto, S; Sato, N, 2004) |
"Lenalidomide has hematologic activity in patients with low-risk myelodysplastic syndromes who have no response to erythropoietin or who are unlikely to benefit from conventional therapy." | 5.11 | Efficacy of lenalidomide in myelodysplastic syndromes. ( Buresh, A; Fuchs, D; Heaton, R; Knight, R; Kurtin, S; List, A; Mahadevan, D; Rimsza, L; Roe, DJ; Zeldis, JB, 2005) |
"Thalidomide (Thal) can overcome drug resistance in multiple myeloma (MM) but is associated with somnolence, constipation, and neuropathy." | 5.10 | Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. ( Anderson, KC; Balinski, K; Catley, LP; Chauhan, D; Davies, F; Deocampo, R; Doss, D; Freeman, A; Hideshima, T; Kelly, K; LeBlanc, R; McKenney, M; Mechlowicz, J; Mitsiades, C; Rich, R; Richardson, PG; Ryoo, JJ; Schlossman, RL; Weller, E; Zeldis, J, 2002) |
"In a randomized, placebo-controlled, double-blind trial, thalidomide or placebo together with glucocorticoids and either cyclosporine or tacrolimus was administered as initial therapy for clinical extensive chronic graft-versus-host disease (cGVHD)." | 5.09 | Thalidomide for treatment of patients with chronic graft-versus-host disease. ( Anasetti, C; Appelbaum, FR; Deeg, HJ; Flowers, ME; Koc, S; Leisenring, W; Martin, PJ; Nash, RA; Sanders, JE; Storb, R; Witherspoon, RP, 2000) |
"Thalidomide has been reported to be an effective agent for treatment of chronic graft-versus-host disease (CGVHD)." | 5.08 | Thalidomide as salvage therapy for chronic graft-versus-host disease. ( Blume, KG; Chao, N; Forman, SJ; Kashyap, A; Long, GD; Margolin, K; Molina, A; Nademanee, A; Negrin, RS; Niland, JC; O'Donnell, MR; Parker, PM; Planas, I; Schmidt, GM; Smith, EP; Snyder, DS; Somlo, G; Spielberger, R; Stein, AS; Stepan, DE; Wilsman, K; Zwingenberger, K, 1995) |
"Thalidomide- or lenalidomide-based maintenance therapy improves PFS but not OS in MM and increases risks of grade 3-4 adverse events, including thromboembolism, peripheral neuropathy, neutropenia, and infection." | 4.93 | Maintenance Therapy With Immunomodulatory Drugs in Multiple Myeloma: A Meta-Analysis and Systematic Review. ( Andersson, BS; Berenson, JR; Champlin, RE; Chang, VT; Guan, X; Qazilbash, MH; Shen, Y; Wang, J; Wang, ML; Wang, Y; Yang, F; Zhang, W, 2016) |
"In this report, a panel of European myeloma experts discuss the role of pomalidomide in the treatment of relapsed and refractory multiple myeloma (RRMM)." | 4.90 | Expert panel consensus statement on the optimal use of pomalidomide in relapsed and refractory multiple myeloma. ( Cavo, M; Davies, FE; Delforge, M; Dimopoulos, MA; Facon, T; Hansson, M; Leleu, X; Ludwig, H; Mateos, MV; Miguel, JF; Moreau, P; Morgan, GJ; Palumbo, A; Schey, SA; Sonneveld, P; Weisel, K; Zweegman, S, 2014) |
"The introduction of new agents in the treatment of multiple myeloma, such as thalidomide, bortezomib, or lenalidomide, has represented an important step forward in the management of this disease, with improvement in both treatment response and patient survival." | 4.87 | Management of the adverse effects of lenalidomide in multiple myeloma. ( González Rodríguez, AP, 2011) |
"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) |
"This review summarises the mechanism of action of immunomodulatory analogues of thalidomide and their use in myelodysplastic syndromes." | 4.83 | Immunomodulatory drugs in myelodysplastic syndromes. ( Galili, N; Raza, A, 2006) |
"Lenalidomide was approved in Japan for the treatment of patients with myelodysplastic syndromes associated with a 5q deletion (del 5q-MDS) in August 2010." | 4.31 | Lenalidomide treatment of Japanese patients with myelodysplastic syndromes with 5q deletion: a post-marketing surveillance study. ( Aoki, Y; Minehata, K; Motegi, Y; Uno, S, 2023) |
"Determinants of the efficacy and safety of pomalidomide (POM) monotherapy or POM plus dexamethasone (DEX) (POM/DEX) for relapsed and refractory multiple myeloma (RRMM) were examined retrospectively in a real-world clinical practice setting in Japan." | 3.88 | Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum. ( Fuchida, SI; Hino, M; Iida, M; Imada, K; Ishikawa, J; Kamitsuji, Y; Kanakura, Y; Kaneko, H; Kobayashi, M; Kosugi, S; Kuroda, J; Matsuda, M; Matsui, T; Matsumura, I; Matsumura-Kimoto, Y; Nakaya, A; Nomura, S; Ohta, K; Shibayama, H; Shimazaki, C; Takaori-Kondo, A; Tanaka, H; Uchiyama, H; Uoshima, N; Wada, K; Yagi, H; Yokota, I, 2018) |
"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 well-known dose-limiting toxicity associated with lenalidomide plus dexamethasone treatment in patients with multiple myeloma; however, little is known about its management and associated outcomes in the real world setting." | 3.83 | An international, multicenter, prospective, observational study of neutropenia in patients being treated with lenalidomide + dexamethasone for relapsed or relapsed/refractory multiple myeloma (RR-MM). ( Cooney, J; Gray, D; Greil, R; Leleu, X; Minarik, J; O'Gorman, P; Sanz, RG; Szabo, Z; Terpos, E; Williams, C, 2016) |
"In order to evaluate the main adverse effects of drug protocols using bortezomib and/or thalidomide for the treatment of multiple myeloma, we conducted a prospective study." | 3.83 | Pharmacovigilance of patients with multiple myeloma being treated with bortezomib and/or thalidomide. ( Atalla, A; Castro, TB; Hallack Neto, AE; Ribeiro, LC, 2016) |
"Neutropenia may develop as an adverse event in patients with multiple myeloma receiving lenalidomide (LEN) plus dexamethasone (DEX) therapy." | 3.83 | Risk factors for neutropenia with lenalidomide plus dexamethasone therapy for multiple myeloma. ( Kimura, M; Kokuryou, T; Matsuoka, T; Mitani, Y; Nakao, T; Okada, K; Usami, E; Yamakawa, M; Yoshimura, T, 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) |
"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) |
"The combination of lenalidomide, bortezomib and dexamethasone (RVD) has shown excellent efficacy in patients with relapsed or refractory multiple myeloma (RRMM)." | 3.79 | Lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone for heavily pretreated relapsed or refractory multiple myeloma. ( Chen, C; Jimenez-Zepeda, VH; Kukreti, V; Reece, DE; Tiedemann, R; Trudel, S, 2013) |
"The immunomodulatory drugs (IMiDs) lenalidomide and pomalidomide yield high response rates in patients with multiple myeloma, but the use of IMiDs in multiple myeloma is associated with neutropenia and increased risk for venous thromboembolism (VTE) by mechanisms that are unknown." | 3.76 | Immunomodulatory derivatives induce PU.1 down-regulation, myeloid maturation arrest, and neutropenia. ( Hassett, AC; Lentzsch, S; List, A; Mapara, MY; Monaghan, SA; Moscinski, L; Pal, R; Ragni, MV; Roodman, GD; Schafer, P, 2010) |
"Lenalidomide combined with dexamethasone has significant clinical activity in the treatment of multiple myeloma (MM)." | 3.74 | Should prophylactic granulocyte-colony stimulating factor be used in multiple myeloma patients developing neutropenia under lenalidomide-based therapy? ( Colado, E; García-Sanz, R; Mateos, MV; Olazábal, J; San-Miguel, J, 2008) |
"To report thrombocytopenia in a patient prescribed thalidomide for multiple myeloma (MM)." | 3.73 | Thalidomide-associated thrombocytopenia. ( Brouwers, JR; Duyvendak, M; Kingma, BJ; Naunton, M, 2005) |
"Among patients with previously untreated follicular lymphoma, efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy (with both regimens followed by rituximab maintenance therapy)." | 2.87 | Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. ( Ando, K; André, M; Bartlett, NL; Bouabdallah, K; Bouabdallah, R; Brice, P; Cartron, G; Casasnovas, RO; Daguindau, N; Feugier, P; Flinn, IW; Fowler, NH; Fruchart, C; Gomes da Silva, M; Haioun, C; Larouche, JF; Le Gouill, S; Libby, EN; Liu, D; López-Guillermo, A; Maisonneuve, H; Martin Garcia-Sancho, A; Morschhauser, F; Palomba, ML; Pica, GM; Ribrag, V; Salles, GA; Sehn, LH; Tilly, H; Tobinai, K; Wang, J; Xerri, L; Ysebaert, L; Zachée, P, 2018) |
"Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib)." | 2.84 | Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. ( Casadebaig Bravo, ML; Drach, J; Fu, T; Goy, A; Habermann, TM; Kalayoglu Besisik, S; Luigi Zinzani, P; Ramchandren, R; Takeshita, K; Tuscano, JM; Witzig, TE; Zhang, L, 2017) |
" Continous high dosing schedules are poorly tolerated and minimally active." | 2.84 | A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher-risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia. ( Carraway, HE; DeZern, A; Gojo, I; Gore, SD; Smith, BD; Zeidan, AM, 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) |
"Lenalidomide was administered orally on escalating doses, with cycle 1 doses of 2." | 2.82 | Results of a phase II study of lenalidomide and rituximab for refractory/relapsed chronic lymphocytic leukemia. ( Chavez, JC; Dalia, S; Kharfan-Dabaja, MA; Komrokji, R; Lancet, J; Locke, FL; Nodzon, L; Pinilla-Ibarz, J; Piris-Villaespesa, M; Powers, J; Sokol, L; Sotomayor, EM; Turba, E, 2016) |
"Neutropenia was the most common grade 3 and 4 toxicity, but no maximum tolerated dose was identified." | 2.80 | A phase I study of bendamustine, lenalidomide and rituximab in relapsed and refractory lymphomas. ( Cheson, BD; Crawford, J, 2015) |
" The maximum tolerated dose (MTD) of lenalidomide given in combination with gemcitabine was defined as the highest dose level at which no more than one out of four (25%) subjects experiences a dose-limiting toxicity (DLT)." | 2.80 | A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer. ( Liljefors, M; Rossmann, E; Ullenhag, GJ, 2015) |
"Lenalidomide was given orally 21/28 days per cycle for 1 year, at escalated dose of 15 to 20 mg during phase 1 to determine the MTD; the phase 2 part was conducted at the MTD." | 2.80 | Lenalidomide is safe and active in Waldenström macroglobulinemia. ( Arnulf, B; Bakala, J; Banos, A; Bories, C; Brice, P; Choquet, S; Demarquette, H; Dib, M; Fouquet, G; Guidez, S; Herbaux, C; Karlin, L; Leblond, V; LeGouill, S; Leleu, X; Louni, C; Martin, A; Morel, P; Nudel, M; Ohyba, B; Petillon, MO; Poulain, S; Salles, G; Thielemans, B; Tournilhac, O, 2015) |
" A total of 43 patients were recruited into three CPT plus thalidomide cohorts based on CPT dosage in sequence: 5 mg/kg (n = 11), 8 mg/kg (n = 17), and 10 mg/kg (n = 15)." | 2.79 | A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma. ( Chen, WM; Geng, C; Hou, J; Huang, Z; Ke, X; Liu, Y; Qiu, L; Wang, F; Wang, Z; Wei, N; Wei, P; Xi, H; Yang, S; Zhao, Y; Zheng, X; Zhu, B, 2014) |
"Lenalidomide was safely titrated to 20 mg/day; the MTDEL was not reached." | 2.77 | Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. ( Bloor, A; Bosch, F; Bühler, A; Chanan-Khan, AA; Coutré, S; Dreisbach, L; Ferrajoli, A; Frankfurt, O; Furman, RR; Gobbi, M; Gribben, JG; Hallek, M; Heerema, NA; Hillmen, P; Hurd, DD; Kimby, E; Mahadevan, D; Moutouh-de Parseval, L; Sekeres, MA; Shah, S; Stilgenbauer, S; Uharek, L; Wendtner, CM; Zhang, J, 2012) |
"Thalidomide has proven its efficacy in refractory cutaneous lupus disease, although it is not exempt from significant side effects and frequent relapses after withdrawal." | 2.77 | Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus. ( Ávila, G; Cortés-Hernández, J; Ordi-Ros, J; Vilardell-Tarrés, M, 2012) |
"Lenalidomide is an anti-angiogenic IMiD(®) immunomodulatory drug." | 2.76 | A prospective clinical trial of lenalidomide with topotecan in women with advanced epithelial ovarian carcinoma. ( Carter, JS; Downs, LS, 2011) |
"Lenalidomide was generally well tolerated and no grade 4 hematologic toxicities were noted." | 2.75 | Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis. ( Baz, R; Chanan-Khan, AA; Finley-Oliver, E; Hussein, MA; Lebovic, D; Lee, K; Miller, KC; Patel, M; Sher, T; Wood, M, 2010) |
"Oral lenalidomide 25 mg was self-administered once daily on days 1-21 every 28 d for up to 52 weeks, according to tolerability or until disease progression." | 2.74 | Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma. ( Ervin-Haynes, A; Habermann, TM; Justice, G; Lossos, IS; McBride, K; Pietronigro, D; Takeshita, K; Tuscano, JM; Vose, JM; Wiernik, PH; Wride, K; Zeldis, JB, 2009) |
"Lenalidomide therapy was continued indefinitely in patients exhibiting clinical benefit." | 2.74 | Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. ( Bueso-Ramos, C; Cortes, J; Ferrajoli, A; Garcia-Manero, G; Kantarjian, HM; Manshouri, T; Quintás-Cardama, A; Ravandi, F; Thomas, D; Verstovsek, S, 2009) |
"Lenalidomide is a novel immunomodulatory agent with antiproliferative activities." | 2.74 | Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's Lymphoma. ( Cole, C; Ervin-Haynes, A; Justice, G; Kaplan, H; Moore, T; Pietronigro, D; Reeder, C; Takeshita, K; Voralia, M; Vose, JM; Wiernik, PH; Witzig, TE; Zeldis, JB, 2009) |
"Pomalidomide was continued following the 4-week MTD study in 17/20 patients for a median of 14 months." | 2.73 | Alternate day pomalidomide retains anti-myeloma effect with reduced adverse events and evidence of in vivo immunomodulation. ( Daniel, Y; Gyertson, K; Kazmi, M; Schey, SA; Streetly, MJ; Zeldis, JB, 2008) |
"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) |
"Neutropenia was a dose limiting factor with half of the cases (7/14) presenting with severe neutropenia (grade 3-4), but a response was observed in all of them on administration of G-CSF." | 2.71 | [Single-agent thalidomide for advanced and refractory multiple myeloma]. ( Fujimura, K; Imagawa, J; Katayama, Y; Kimura, A; Noda, M; Okikawa, Y; Okita, H; Sakai, A; Takimoto, Y, 2003) |
"Thalidomide is a potent teratogen that causes dysmelia in humans." | 2.70 | A randomized phase II trial of thalidomide, an angiogenesis inhibitor, in patients with androgen-independent prostate cancer. ( Chen, CC; Dahut, W; Dixon, S; Duray, P; Figg, WD; Floeter, MK; Gubish, E; Hamilton, M; Jones, E; Kohler, DR; Krüger, EA; Linehan, WM; Pluda, JM; Premkumar, A; Reed, E; Steinberg, SM; Tompkins, A, 2001) |
"Lenalidomide has multifaceted antimyeloma properties, including direct tumoricidal and immunomodulatory effects." | 2.55 | Lenalidomide in combination or alone as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma: a review of options for and against. ( Anderson, KC; Attal, M; Holstein, SA; McCarthy, PL; Richardson, PG; Schlossman, RL, 2017) |
"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) |
" Population pharmacokinetic analyses were conducted to determine the pharmacokinetics of intravenous daratumumab in combination therapy versus monotherapy, evaluate the effect of patient- and disease-related covariates on drug disposition, and examine the relationships between daratumumab exposure and efficacy/safety outcomes." | 1.48 | Pharmacokinetics and Exposure-Response Analyses of Daratumumab in Combination Therapy Regimens for Patients with Multiple Myeloma. ( Belch, A; Capra, M; Clemens, PL; Dimopoulos, MA; Gomez, D; Ho, PJ; Iida, S; Jansson, R; Leiba, M; Medvedova, E; Min, CK; Schecter, J; Sonneveld, P; Sun, YN; Xu, XS; Zhang, L, 2018) |
"Lenalidomide was well tolerated in intensively pretreated and elderly MM patients, including those with RI." | 1.38 | Prognostic risk factor evaluation in patients with relapsed or refractory multiple myeloma receiving lenalidomide treatment: analysis of renal function by eGFR and of additional comorbidities by comorbidity appraisal. ( Engelhardt, M; Ihorst, G; Kleber, M; Koch, B; Udi, J; Wäsch, R, 2012) |
"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) |
"Lenalidomide therapy is a potential alternative or adjunctive treatment for patients with severe, chronic DLE that is refractory to standard therapies." | 1.35 | Lenalidomide for the treatment of resistant discoid lupus erythematosus. ( Albrecht, J; Bonilla-Martinez, Z; Okawa, J; Rose, M; Rosenbach, M; Shah, A; Werth, VP, 2009) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 2 (2.08) | 18.2507 |
2000's | 26 (27.08) | 29.6817 |
2010's | 61 (63.54) | 24.3611 |
2020's | 7 (7.29) | 2.80 |
Authors | Studies |
---|---|
Wang, Y | 3 |
Zhang, M | 1 |
Song, W | 1 |
Cai, Q | 1 |
Zhang, L | 3 |
Sun, X | 1 |
Zou, L | 1 |
Zhang, H | 1 |
Wang, L | 1 |
Xue, H | 1 |
Uno, S | 1 |
Motegi, Y | 1 |
Minehata, K | 1 |
Aoki, Y | 1 |
Xia, Z | 1 |
Leng, Y | 1 |
Fang, B | 1 |
Liang, Y | 1 |
Li, W | 1 |
Fu, C | 1 |
Yang, L | 1 |
Ke, X | 2 |
Jiang, H | 1 |
Weng, J | 1 |
Liu, L | 1 |
Zhao, Y | 2 |
Zhang, X | 3 |
Huang, Z | 2 |
Liu, A | 1 |
Shi, Q | 1 |
Gao, Y | 1 |
Chen, X | 1 |
Pan, L | 1 |
Cai, Z | 1 |
Wang, Z | 2 |
Fan, Y | 1 |
Hou, M | 1 |
Ma, Y | 2 |
Hu, J | 1 |
Liu, J | 1 |
Zhou, J | 1 |
Meng, H | 1 |
Lu, X | 1 |
Li, F | 1 |
Ren, H | 1 |
Huang, B | 1 |
Shao, Z | 1 |
Zhou, H | 1 |
Hu, Y | 2 |
Yang, S | 2 |
Zheng, X | 2 |
Wei, P | 2 |
Pang, H | 1 |
Yu, W | 1 |
Liu, Y | 2 |
Gao, S | 1 |
Yan, L | 1 |
Jing, H | 1 |
Du, J | 1 |
Ling, W | 1 |
Zhang, J | 2 |
Sui, W | 1 |
Wang, F | 2 |
Li, X | 1 |
Chen, W | 1 |
Tekinalp, A | 1 |
Gedük, A | 1 |
Akdeniz, A | 1 |
Terzi Demirsoy, E | 1 |
Gürsoy, V | 1 |
Aslaner Ak, M | 1 |
Bağcı, M | 1 |
Seçilmiş, S | 1 |
Keklik Karadağ, F | 1 |
Oruç Uysal, A | 1 |
Doğan, A | 1 |
Demircioğlu, S | 1 |
Erol, HA | 1 |
Aslan, C | 1 |
Özkalemkaş, F | 1 |
Ertop, Ş | 1 |
Dağlı, M | 1 |
Dal, MS | 1 |
Saydam, G | 1 |
Merter, M | 1 |
Ural, C | 1 |
Çeneli, Ö | 1 |
Zhou, X | 1 |
Steinhardt, MJ | 1 |
Grathwohl, D | 1 |
Meckel, K | 1 |
Nickel, K | 1 |
Leicht, HB | 1 |
Krummenast, F | 1 |
Einsele, H | 2 |
Rasche, L | 1 |
Kortüm, KM | 1 |
Dimopoulos, MA | 7 |
Terpos, E | 3 |
Boccadoro, M | 5 |
Delimpasi, S | 1 |
Beksac, M | 2 |
Katodritou, E | 1 |
Moreau, P | 4 |
Baldini, L | 1 |
Symeonidis, A | 1 |
Bila, J | 1 |
Oriol, A | 1 |
Mateos, MV | 4 |
Orfanidis, I | 1 |
Ahmadi, T | 1 |
Ukropec, J | 1 |
Kampfenkel, T | 1 |
Schecter, JM | 1 |
Qiu, Y | 1 |
Amin, H | 1 |
Vermeulen, J | 1 |
Carson, R | 1 |
Sonneveld, P | 4 |
Delgado, J | 1 |
Zienowicz, M | 1 |
van Hennik, PB | 1 |
Moreau, A | 1 |
Gisselbrecht, C | 1 |
Enzmann, H | 1 |
Pignatti, F | 1 |
Thieblemont, C | 1 |
Tilly, H | 2 |
Gomes da Silva, M | 2 |
Casasnovas, RO | 2 |
Fruchart, C | 2 |
Morschhauser, F | 2 |
Haioun, C | 2 |
Lazarovici, J | 1 |
Grosicka, A | 1 |
Perrot, A | 1 |
Trotman, J | 1 |
Sebban, C | 1 |
Caballero, D | 1 |
Greil, R | 2 |
van Eygen, K | 1 |
Cohen, AM | 1 |
Gonzalez, H | 1 |
Bouabdallah, R | 3 |
Oberic, L | 1 |
Corront, B | 1 |
Choufi, B | 1 |
Lopez-Guillermo, A | 2 |
Catalano, J | 2 |
Van Hoof, A | 1 |
Briere, J | 1 |
Cabeçadas, J | 1 |
Salles, G | 2 |
Gaulard, P | 1 |
Bosly, A | 1 |
Coiffier, B | 1 |
Wang, GM | 1 |
Yang, GZ | 1 |
Huang, ZX | 1 |
Zhong, YP | 1 |
Jin, FY | 1 |
Liao, AJ | 1 |
Wang, XM | 1 |
Fu, ZZ | 1 |
Liu, H | 1 |
Li, XL | 1 |
Zhou, JF | 1 |
Meng, FY | 1 |
Huang, XJ | 1 |
Chen, WM | 3 |
Lu, J | 2 |
Witzig, TE | 3 |
Luigi Zinzani, P | 1 |
Habermann, TM | 2 |
Tuscano, JM | 2 |
Drach, J | 1 |
Ramchandren, R | 1 |
Kalayoglu Besisik, S | 1 |
Takeshita, K | 4 |
Casadebaig Bravo, ML | 1 |
Fu, T | 1 |
Goy, A | 1 |
Blair, HA | 1 |
Richardson, PG | 4 |
Holstein, SA | 1 |
Schlossman, RL | 2 |
Anderson, KC | 5 |
Attal, M | 2 |
McCarthy, PL | 1 |
Matsumura-Kimoto, Y | 1 |
Kuroda, J | 1 |
Kaneko, H | 1 |
Kamitsuji, Y | 1 |
Fuchida, SI | 1 |
Nakaya, A | 1 |
Shibayama, H | 1 |
Uoshima, N | 1 |
Yokota, I | 1 |
Uchiyama, H | 1 |
Yagi, H | 1 |
Kosugi, S | 1 |
Matsui, T | 1 |
Ishikawa, J | 1 |
Matsuda, M | 1 |
Ohta, K | 1 |
Iida, M | 1 |
Tanaka, H | 1 |
Kobayashi, M | 1 |
Wada, K | 1 |
Shimazaki, C | 1 |
Nomura, S | 1 |
Imada, K | 1 |
Hino, M | 1 |
Matsumura, I | 1 |
Kanakura, Y | 1 |
Takaori-Kondo, A | 1 |
Fowler, NH | 1 |
Feugier, P | 1 |
Palomba, ML | 1 |
Libby, EN | 1 |
Flinn, IW | 1 |
Maisonneuve, H | 1 |
Ysebaert, L | 1 |
Bartlett, NL | 1 |
Bouabdallah, K | 1 |
Brice, P | 2 |
Ribrag, V | 1 |
Daguindau, N | 1 |
Le Gouill, S | 1 |
Pica, GM | 1 |
Martin Garcia-Sancho, A | 1 |
Larouche, JF | 1 |
Ando, K | 1 |
André, M | 1 |
Zachée, P | 1 |
Sehn, LH | 1 |
Tobinai, K | 2 |
Cartron, G | 1 |
Liu, D | 1 |
Wang, J | 2 |
Xerri, L | 1 |
Salles, GA | 1 |
Xu, XS | 1 |
Ho, PJ | 1 |
Belch, A | 2 |
Leiba, M | 1 |
Capra, M | 1 |
Gomez, D | 1 |
Medvedova, E | 1 |
Iida, S | 1 |
Min, CK | 2 |
Schecter, J | 1 |
Jansson, R | 1 |
Sun, YN | 1 |
Clemens, PL | 1 |
Dytfeld, D | 1 |
Grosicki, S | 1 |
Takezako, N | 1 |
Hori, M | 1 |
Leleu, X | 4 |
LeBlanc, R | 2 |
Suzuki, K | 1 |
Raab, MS | 1 |
Popa McKiver, M | 1 |
Jou, YM | 1 |
Shelat, SG | 1 |
Robbins, M | 1 |
Rafferty, B | 1 |
San-Miguel, J | 2 |
Niesvizky, R | 3 |
Martin, TG | 1 |
Bensinger, WI | 1 |
Alsina, M | 2 |
Siegel, DS | 3 |
Kunkel, LA | 1 |
Wong, AF | 1 |
Lee, S | 1 |
Orlowski, RZ | 2 |
Wang, M | 2 |
Safran, H | 1 |
Charpentier, KP | 1 |
Kaubisch, A | 1 |
Mantripragada, K | 1 |
Dubel, G | 1 |
Perez, K | 1 |
Faricy-Anderson, K | 1 |
Miner, T | 1 |
Eng, Y | 1 |
Victor, J | 1 |
Plette, A | 1 |
Espat, J | 1 |
Bakalarski, P | 1 |
Wingate, P | 1 |
Berz, D | 1 |
Luppe, D | 1 |
Martel, D | 1 |
Rosati, K | 1 |
Aparo, S | 1 |
Martin, T | 1 |
Bensinger, W | 1 |
Kavalerchik, E | 1 |
Huang, M | 1 |
Vij, R | 2 |
Hofmeister, CC | 1 |
Baz, R | 2 |
Jagannath, S | 1 |
Chen, C | 3 |
Lonial, S | 2 |
Jakubowiak, A | 1 |
Bahlis, N | 1 |
Song, K | 1 |
Raje, N | 1 |
Shustik, C | 1 |
Lentzsch, S | 2 |
Lacy, M | 1 |
Mikhael, J | 1 |
Matous, J | 2 |
Vesole, D | 1 |
Chen, M | 1 |
Zaki, MH | 1 |
Jacques, C | 2 |
Yu, Z | 2 |
Palumbo, A | 6 |
Bringhen, S | 1 |
Larocca, A | 2 |
Rossi, D | 1 |
Di Raimondo, F | 2 |
Magarotto, V | 2 |
Patriarca, F | 2 |
Levi, A | 1 |
Benevolo, G | 2 |
Vincelli, ID | 1 |
Grasso, M | 1 |
Franceschini, L | 1 |
Gottardi, D | 1 |
Zambello, R | 2 |
Montefusco, V | 1 |
Falcone, AP | 1 |
Omedé, P | 2 |
Marasca, R | 1 |
Morabito, F | 2 |
Mina, R | 1 |
Guglielmelli, T | 1 |
Nozzoli, C | 1 |
Passera, R | 1 |
Gaidano, G | 1 |
Offidani, M | 3 |
Ria, R | 1 |
Petrucci, MT | 4 |
Musto, P | 4 |
Cavo, M | 4 |
Delforge, M | 2 |
Ludwig, H | 1 |
Morgan, GJ | 1 |
Davies, FE | 1 |
Schey, SA | 3 |
Zweegman, S | 2 |
Hansson, M | 1 |
Weisel, K | 2 |
Facon, T | 3 |
Miguel, JF | 1 |
Ivanov, V | 1 |
Coso, D | 1 |
Chetaille, B | 1 |
Esterni, B | 1 |
Olive, D | 1 |
Aurran-Schleinitz, T | 1 |
Schiano, JM | 1 |
Stoppa, AM | 2 |
Broussais-Guillaumot, F | 1 |
Blaise, D | 1 |
Sun, HL | 1 |
Atenafu, EG | 1 |
Yeboah, E | 1 |
Reece, DE | 2 |
Trudel, S | 2 |
Kukreti, V | 2 |
Masih-Khan, E | 1 |
Winter, A | 1 |
Cheng, J | 1 |
Talamo, G | 1 |
Malysz, J | 1 |
Ochmann, M | 1 |
Lamy, T | 2 |
Loughran, TP | 1 |
Huang, H | 1 |
Zhou, L | 1 |
Peng, L | 1 |
Fu, W | 1 |
Zhang, C | 1 |
Hou, J | 2 |
Geng, C | 1 |
Qiu, L | 2 |
Xi, H | 1 |
Wei, N | 1 |
Zhu, B | 1 |
Costa, LJ | 1 |
Fanning, SR | 1 |
Stephenson, J | 1 |
Afrin, LB | 1 |
Kistner-Griffin, E | 1 |
Bentz, TA | 1 |
Stuart, RK | 1 |
Cavallo, F | 2 |
Gay, F | 2 |
Ben Yehuda, D | 2 |
Pezzatti, S | 1 |
Caravita, T | 1 |
Cerrato, C | 1 |
Ribakovsky, E | 1 |
Genuardi, M | 1 |
Cafro, A | 1 |
Marcatti, M | 1 |
Catalano, L | 1 |
Carella, AM | 1 |
Zamagni, E | 1 |
Evangelista, A | 1 |
Ciccone, G | 1 |
Crippa, C | 1 |
Corradini, P | 1 |
Nagler, A | 1 |
Roziaková, L | 1 |
Mistrík, M | 1 |
Bátorová, A | 1 |
Cheson, BD | 1 |
Crawford, J | 1 |
Ullenhag, GJ | 1 |
Rossmann, E | 1 |
Liljefors, M | 1 |
Fouquet, G | 1 |
Guidez, S | 1 |
Petillon, MO | 1 |
Louni, C | 1 |
Ohyba, B | 1 |
Dib, M | 2 |
Poulain, S | 1 |
Herbaux, C | 1 |
Martin, A | 1 |
Thielemans, B | 1 |
Choquet, S | 1 |
Bakala, J | 1 |
Bories, C | 1 |
Demarquette, H | 1 |
Nudel, M | 1 |
Tournilhac, O | 1 |
Arnulf, B | 1 |
LeGouill, S | 1 |
Morel, P | 1 |
Banos, A | 2 |
Karlin, L | 1 |
Leblond, V | 1 |
Butrym, A | 1 |
Rybka, J | 1 |
Łacina, P | 1 |
Gębura, K | 1 |
Frontkiewicz, D | 1 |
Bogunia-Kubik, K | 1 |
Mazur, G | 1 |
Ruan, J | 1 |
Martin, P | 1 |
Shah, B | 1 |
Schuster, SJ | 1 |
Smith, SM | 1 |
Furman, RR | 2 |
Christos, P | 1 |
Rodriguez, A | 1 |
Svoboda, J | 1 |
Lewis, J | 1 |
Katz, O | 1 |
Coleman, M | 2 |
Leonard, JP | 2 |
Yang, F | 1 |
Shen, Y | 1 |
Zhang, W | 1 |
Chang, VT | 1 |
Andersson, BS | 1 |
Qazilbash, MH | 1 |
Champlin, RE | 1 |
Berenson, JR | 1 |
Guan, X | 1 |
Wang, ML | 1 |
Zagouri, F | 1 |
Roussou, M | 1 |
Kastritis, E | 1 |
Gavriatopoulou, M | 1 |
Eleutherakis-Papaiakovou, E | 1 |
Kanellias, N | 1 |
Kalapanida, D | 1 |
Christoulas, D | 1 |
Migkou, M | 1 |
Ogura, M | 1 |
Imaizumi, Y | 1 |
Uike, N | 1 |
Asou, N | 1 |
Utsunomiya, A | 1 |
Uchida, T | 1 |
Aoki, T | 1 |
Tsukasaki, K | 1 |
Taguchi, J | 1 |
Choi, I | 1 |
Maruyama, D | 1 |
Nosaka, K | 1 |
Chen, N | 1 |
Midorikawa, S | 1 |
Ohtsu, T | 1 |
Hulin, C | 2 |
Macro, M | 1 |
Caillot, D | 1 |
Chaleteix, C | 1 |
Roussel, M | 1 |
Garderet, L | 1 |
Royer, B | 1 |
Brechignac, S | 1 |
Tiab, M | 1 |
Puyade, M | 1 |
Escoffre, M | 1 |
Pegourie, B | 1 |
Chaoui, D | 1 |
Jaccard, A | 1 |
Slama, B | 1 |
Marit, G | 1 |
Laribi, K | 1 |
Godmer, P | 1 |
Luycx, O | 1 |
Eisenmann, JC | 1 |
Allangba, O | 1 |
Araujo, C | 1 |
Fontan, J | 1 |
Belhadj, K | 1 |
Wetterwald, M | 1 |
Dorvaux, V | 1 |
Fermand, JP | 1 |
Rodon, P | 1 |
Kolb, B | 1 |
Glaisner, S | 1 |
Malfuson, JV | 1 |
Lenain, P | 1 |
Biron, L | 1 |
Planche, L | 1 |
Caillon, H | 1 |
Avet-Loiseau, H | 1 |
Dejoie, T | 1 |
Sanz, RG | 1 |
Cooney, J | 1 |
O'Gorman, P | 1 |
Minarik, J | 1 |
Williams, C | 1 |
Gray, D | 1 |
Szabo, Z | 1 |
Castro, TB | 1 |
Hallack Neto, AE | 1 |
Atalla, A | 1 |
Ribeiro, LC | 1 |
Chavez, JC | 1 |
Piris-Villaespesa, M | 1 |
Dalia, S | 1 |
Powers, J | 1 |
Turba, E | 1 |
Nodzon, L | 1 |
Komrokji, R | 1 |
Sokol, L | 1 |
Locke, FL | 1 |
Lancet, J | 1 |
Sotomayor, EM | 1 |
Kharfan-Dabaja, MA | 1 |
Pinilla-Ibarz, J | 1 |
Mitani, Y | 1 |
Usami, E | 1 |
Kimura, M | 1 |
Nakao, T | 1 |
Okada, K | 1 |
Matsuoka, T | 1 |
Kokuryou, T | 1 |
Yoshimura, T | 1 |
Yamakawa, M | 1 |
Zeidan, AM | 1 |
Smith, BD | 1 |
Carraway, HE | 1 |
Gojo, I | 1 |
DeZern, A | 1 |
Gore, SD | 1 |
Rammaert, B | 1 |
Candon, S | 1 |
Maunoury, C | 1 |
Bougnoux, ME | 1 |
Jouvion, G | 1 |
Braun, T | 1 |
Correas, JM | 1 |
Lortholary, O | 1 |
Lee, JH | 1 |
Huang, SY | 1 |
Lee, JJ | 1 |
Liu, T | 1 |
Yoon, SS | 1 |
Kim, K | 1 |
Shen, ZX | 1 |
Eom, HS | 1 |
Kim, HJ | 1 |
Lee, JO | 1 |
Kwak, JY | 1 |
Yiu, W | 1 |
Chen, G | 1 |
Ervin-Haynes, A | 3 |
Ferreri, AJ | 1 |
Sassone, M | 1 |
Zaja, F | 1 |
Re, A | 1 |
Spina, M | 1 |
Rocco, AD | 1 |
Fabbri, A | 1 |
Stelitano, C | 1 |
Frezzato, M | 1 |
Rusconi, C | 1 |
Couto, S | 1 |
Ren, Y | 1 |
Arcari, A | 1 |
Bertoldero, G | 1 |
Nonis, A | 1 |
Scarfò, L | 1 |
Calimeri, T | 1 |
Cecchetti, C | 1 |
Chiozzotto, M | 1 |
Govi, S | 1 |
Ponzoni, M | 1 |
Sekeres, MA | 2 |
Maciejewski, JP | 1 |
Giagounidis, AA | 1 |
Wride, K | 2 |
Knight, R | 3 |
Raza, A | 2 |
List, AF | 2 |
Treon, SP | 1 |
Soumerai, JD | 1 |
Branagan, AR | 1 |
Hunter, ZR | 1 |
Patterson, CJ | 1 |
Ioakimidis, L | 1 |
Chu, L | 1 |
Baron, AD | 1 |
Nunnink, JC | 1 |
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Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial[NCT03273452] | Phase 2 | 30 participants (Anticipated) | Interventional | 2017-03-01 | 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 | ||
A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China[NCT01947309] | 176 participants (Actual) | Observational | 2013-11-30 | Terminated (stopped due to Business Decision) | |||
A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortez[NCT00737529] | Phase 2 | 134 participants (Actual) | Interventional | 2008-12-22 | Completed | ||
Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response[NCT04508647] | Phase 2 | 4 participants (Actual) | Interventional | 2020-11-23 | Completed | ||
"A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA The RELEVANCE Trial (Ritu[NCT01650701] | Phase 3 | 1,030 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting | ||
A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma[NCT01938001] | Phase 3 | 358 participants (Actual) | Interventional | 2013-11-21 | Completed | ||
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 | ||
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)[NCT02654132] | Phase 2 | 117 participants (Actual) | Interventional | 2016-03-18 | 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 | ||
Lenalidomide to Reverse Drug Resistance After Lenvatinib Combined With PD-1 Inhibitors in the First-line Treatment of Advanced HCC :a Prospective, Exploratory, Single-arm, Open-label, Multi-center Clinical Study[NCT05831969] | Phase 2 | 23 participants (Anticipated) | Interventional | 2023-06-05 | Not yet recruiting | ||
Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial[NCT00717756] | Phase 2 | 41 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
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 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 | ||
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 III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS[NCT01063179] | Phase 3 | 511 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
A Prospective, Observational Study, to Evaluate the Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for[NCT05218603] | 100 participants (Anticipated) | Observational | 2021-11-30 | Recruiting | |||
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 | ||
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) Versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS[NCT00551928] | Phase 3 | 402 participants (Actual) | Interventional | 2007-06-30 | Active, not recruiting | ||
Phase I/II Study of Lenalidomide and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer[NCT01547260] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia[NCT02302469] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma[NCT01472562] | Phase 2 | 38 participants (Actual) | Interventional | 2011-07-29 | Completed | ||
A Phase I, Multicenter, Open-label, Dose-escalation Study to Assess the Safety of Lenalidomide in Patients With Advanced Adult T-cell Leukemia-lymphoma and Peripheral T-cell Lymphoma[NCT01169298] | Phase 1 | 13 participants (Actual) | Interventional | 2010-07-01 | Completed | ||
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 | ||
Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD)[NCT00867308] | Phase 2 | 32 participants (Actual) | Interventional | 2009-07-31 | Terminated (stopped due to Lack of efficacy) | ||
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, an[NCT00689936] | Phase 3 | 1,623 participants (Actual) | Interventional | 2008-08-21 | Completed | ||
A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma[NCT03710915] | Phase 1 | 3 participants (Actual) | Interventional | 2019-01-12 | Terminated (stopped due to Company decision) | ||
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 Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.[NCT00065156] | Phase 2 | 148 participants (Actual) | Interventional | 2003-06-01 | Completed | ||
Phase II Clinical Study of Zanubrutinib Combined With Bendamustine and Rituximab (ZBR) for Time-limited Treatment of Waldenstrom Macroglobulinemia[NCT05914662] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-02-15 | Recruiting | ||
Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia[NCT00142168] | Phase 2 | 16 participants (Actual) | Interventional | 2004-09-30 | Terminated (stopped due to Toxicity) | ||
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 | ||
Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)[NCT00352794] | Phase 2 | 40 participants (Actual) | Interventional | 2006-07-07 | Completed | ||
A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma[NCT00179673] | Phase 2 | 43 participants (Actual) | Interventional | 2005-08-31 | Completed | ||
Study of Pomalidomide in Anal Cancer Precursors (SPACE): a Phase 2 Study of Immunomodulation in People With Persistent HPV-associated High Grade Squamous Intraepithelial Lesions[NCT03113942] | Phase 2 | 26 participants (Actual) | Interventional | 2017-06-14 | Active, not recruiting | ||
Thrombosis in Newly Diagnosed Multiple Myeloma Patients: a Clinical Audit of Intermediate Dose Low Molecular Weight Heparin[NCT05541978] | 140 participants (Actual) | Observational | 2022-09-01 | Completed | |||
A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow[NCT03992170] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-12-31 | Recruiting | ||
[NCT01036399] | Phase 2 | 9 participants (Actual) | Interventional | 2008-11-30 | Terminated (stopped due to The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene)) | ||
Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma[NCT00179712] | Phase 1/Phase 2 | 60 participants | Interventional | 2005-04-30 | Completed | ||
A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma[NCT00478218] | Phase 2 | 53 participants (Actual) | Interventional | 2006-07-31 | Completed | ||
A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia[NCT00419250] | Phase 1 | 52 participants (Actual) | Interventional | 2006-12-01 | Completed | ||
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma[NCT00420849] | Phase 3 | 587 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In[NCT00405756] | Phase 3 | 459 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus[NCT01408199] | Phase 4 | 15 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
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 | ||
A Multicenter, Open Label Study of Oral Melphalan, Prednisone, and CC-5013 (Revlimid) (MPR) as Induction Therapy in Elderly Newly Diagnosed Multiple Myeloma Patients[NCT00396045] | Phase 1/Phase 2 | 54 participants | Interventional | 2005-01-31 | Completed | ||
A Phase II Trial of the Anti -PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) + Lenalidomide + Dexamethasone as Post Autologous Transplant Consolidation in Patients With High-risk Multiple Myeloma[NCT02906332] | Phase 2 | 12 participants (Actual) | Interventional | 2016-12-12 | Terminated (stopped due to FDA Hold Due to Updated Risks) | ||
QUIREDEX: A National, Open-Label, Multicenter, Randomized, Phase III Study of Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression[NCT00480363] | Phase 3 | 120 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma[NCT01042704] | Phase 1 | 29 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma[NCT04009109] | Phase 2 | 188 participants (Anticipated) | Interventional | 2020-10-21 | Recruiting | ||
Multicenter, Randomized, Double-blind, Phase III Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) With Alteration in 5q- and Anemia Without the Need of Transfusion.[NCT01243476] | Phase 3 | 61 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome[NCT00044382] | Phase 2 | 25 participants | Interventional | 2002-02-01 | Completed | ||
Salvage in Patients With Myelodysplastic Syndrome After Failure of Hypomethylating Agents: Lenalidomide as a Second-line Therapy[NCT01673308] | Phase 2 | 35 participants (Anticipated) | Interventional | 2012-08-31 | Active, not recruiting | ||
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 | ||
Phase II Trial of Lenalidomide in Older Patients (>/= 60 Years) With Untreated Acute Myeloid Leukemia Without Chromosome 5q Abnormalities[NCT00546897] | Phase 2 | 48 participants (Actual) | Interventional | 2007-02-28 | 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 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) | ||
Evaluation of TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect[NCT00121563] | Phase 2 | 90 participants | Interventional | 2005-07-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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 |
Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment. (NCT00737529)
Timeframe: From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Intervention | months (Median) |
---|---|
Lenalidomide | 24.43 |
Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment. (NCT00737529)
Timeframe: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.
Intervention | months (Median) |
---|---|
Lenalidomide | 16.64 |
Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir (NCT00737529)
Timeframe: From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Intervention | months (Median) |
---|---|
Lenalidomide | 5.46 |
Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate 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 adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Intervention | months (Median) |
---|---|
Lenalidomide | 4.01 |
Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Intervention | months (Median) |
---|---|
Lenalidomide | 3.75 |
Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months
Intervention | months (Median) |
---|---|
Lenalidomide | 19.50 |
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. (NCT00737529)
Timeframe: From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide | 29.9 |
The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. 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. (NCT00737529)
Timeframe: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide | 9.0 |
Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Intervention | months (Median) |
---|---|
Lenalidomide | 3.9 |
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. (NCT00737529)
Timeframe: From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Intervention | months (Median) |
---|---|
Lenalidomide | 3.5 |
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 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. (NCT00737529)
Timeframe: From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)
Intervention | participants (Number) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any TEAE | Any TEAE Related to Investigational Product (IP) | Any TEAE Grade 3-5 AE | Any TEAE Grade 3 AE | Any TEAE Grade 4 AE | Any TEAE Grade 5 AE | Any Grade 3-5 AE Related to IP | Any Grade 3 AE Related to IP | Any Grade 4 AE Related to IP | Any Grade 5 AE Related to IP | Any TEAE Serious Adverse Event (SAE) | Any SAE Related to IP | Any TEAE Leading to Stopping of IP | Any Treatment Related AE Leading to Stopping IP | Any AE Leading to Dose Reduction | Any AE Leading to IP Interruption | Any Treatment Related AE Leading to Dose Reduction | Treatment Related AE Leading to IP Interruption | |
Lenalidomide | 132 | 118 | 106 | 101 | 57 | 18 | 90 | 88 | 41 | 2 | 70 | 30 | 28 | 16 | 55 | 81 | 52 | 66 |
"Number of subjects that reached a complete response at the end of single agent induction as defined by a Lugano score of 3 or less on arm MONO - Monotherapy: Ublituximab.~Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake.~Patients who did not reach complete response at this point were then bridged to arm COMBO - Combotherapy: Ublituximab + Umbralisib." (NCT04508647)
Timeframe: 8 weeks post induction
Intervention | Participants (Count of Participants) |
---|---|
Ublituximab Only | 2 |
"Number of subjects that reached a complete response at up to 12 months post induction as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib.~Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake." (NCT04508647)
Timeframe: up to 12 months post induction
Intervention | Participants (Count of Participants) |
---|---|
Ublituximab Only | 2 |
Ublituximab First, Then Ublituximab and Umbralisib | 2 |
"Overall Response Rate for number of subjects as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib.~Overall response rate assessed via PET CT utilizing Lugano deauvile criteria where lymphoma lesions had responded and would include complete response, partial response (> 50% improvement) and stable disease (less than 50 % response)" (NCT04508647)
Timeframe: up to 12 months post induction
Intervention | Participants (Count of Participants) |
---|---|
Ublituximab Only | 2 |
Ublituximab First, Then Ublituximab and Umbralisib | 2 |
DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities. (NCT01938001)
Timeframe: From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm
Intervention | Percentage of Participants (Number) |
---|---|
Rituximab + Lenalidomide (R^2) | 25.3 |
Rituximab + Placebo | 11.1 |
Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date. (NCT01938001)
Timeframe: From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Intervention | months (Median) |
---|---|
Rituximab + Lenalidomide (R^2) | 27.6 |
Rituximab + Placebo | 13.9 |
Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules. (NCT01938001)
Timeframe: From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Intervention | months (Median) |
---|---|
Rituximab + Lenalidomide (R^2) | 39.4 |
Rituximab + Placebo | 14.1 |
Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study. (NCT01938001)
Timeframe: From date of randomization to date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 months)
Intervention | Months (Median) |
---|---|
Rituximab + Lenalidomide (R^2) | 73.1 |
Rituximab + Placebo | 31.8 |
DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed 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 participants was known to be progression free. (NCT01938001)
Timeframe: From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Intervention | months (Median) |
---|---|
Rituximab + Lenalidomide (R^2) | NA |
Rituximab + Placebo | NA |
Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed 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 participants was known to be progression free. (NCT01938001)
Timeframe: From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Intervention | months (Median) |
---|---|
Rituximab + Lenalidomide (R^2) | 36.6 |
Rituximab + Placebo | 21.7 |
Overall survival was defined 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. (NCT01938001)
Timeframe: From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months)
Intervention | Months (Median) |
---|---|
Rituximab + Lenalidomide (R^2) | NA |
Rituximab + Placebo | NA |
Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. (NCT01938001)
Timeframe: From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
Intervention | Percentage of Participants (Number) |
---|---|
Rituximab + Lenalidomide (R^2) | 33.7 |
Rituximab + Placebo | 18.3 |
Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (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. (NCT01938001)
Timeframe: From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
Intervention | Percentage of Participants (Number) |
---|---|
Rituximab + Lenalidomide (R^2) | 77.5 |
Rituximab + Placebo | 53.3 |
TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event. The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death (NCT01938001)
Timeframe: From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)
Intervention | Participants (Count of Participants) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any TEAE | Any TEAE Related to Lenalidomide/Placebo (LEN/PBO) | Any TEAE Related to Rituximab (RIT) | Any Serious TEAE | Any Serious TEAE Related to LEN/PBO | Any Serious TEAE Related to RIT | Any CTCAE Grade (GR) 3/4 TEAE | Any CTCAE GR 3/4 TEAE Related to LEN/PBO | Any CTCAE GR 3/4 TEAE Related to RIT | Any GR 5 TEAE | Any TEAE Leading to Dose Reduction LEN/PBO | Any TEAE Leading to Dose Interruption LEN/PBO | Any TEAE Leading to Dose Interruption RIT | Any TEAE Leading to Discontinuation of LEN/PBO | Any TEAE Leading to Discontinuation of RIT | |
Rituximab + Lenalidomide (R^2) | 174 | 159 | 134 | 45 | 23 | 13 | 121 | 101 | 57 | 2 | 46 | 113 | 59 | 15 | 6 |
Rituximab + Placebo | 173 | 118 | 105 | 25 | 8 | 4 | 58 | 38 | 20 | 2 | 6 | 47 | 38 | 9 | 2 |
"ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment~CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow~sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour~PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour." (NCT02654132)
Timeframe: From first dose to disease progression (up to approximately 21 months)
Intervention | Percent of participants (Number) |
---|---|
E-Pd Cohort | 58.3 |
Pd Cohort | 24.6 |
OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. (NCT02654132)
Timeframe: From randomization to death (up to approximately 52 months)
Intervention | Months (Median) |
---|---|
E-Pd Cohort | 29.80 |
Pd Cohort | 17.41 |
"PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:~1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; 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 that can be attributed solely to the plasma cell proliferative disorder" (NCT02654132)
Timeframe: From randomization to date of progression or death (up to approximately 21 months)
Intervention | Months (Median) |
---|---|
E-Pd Cohort | 10.25 |
Pd Cohort | 4.70 |
"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 |
"radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD~It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed." (NCT00717756)
Timeframe: on average about every 2 months until progression, on average about 4 months.
Intervention | participants (Number) |
---|---|
Lenalidomide | 6 |
"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 |
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 |
The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions. (NCT01472562)
Timeframe: 30 months
Intervention | percentage of patients (Number) |
---|---|
All Patients | 92 |
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 |
Number of participants who experienced at least one grade 3-4 non-hematological toxicity by CTCAE 3.0 that was attributed to lenalidomide. (NCT00867308)
Timeframe: Up to 8 months
Intervention | Participants (Count of Participants) |
---|---|
Lenalidomide 15 mg | 6 |
Lenalidomide 50 mg | 12 |
Number of participants with a complete or partial response according to International Working Group 2006 criteria. (NCT00867308)
Timeframe: 15 weeks
Intervention | Participants (Count of Participants) | |
---|---|---|
Complete response | Partial response | |
Lenalidomide 15 mg | 0 | 0 |
Lenalidomide 50 mg | 0 | 2 |
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 39.1 |
Lenalidomide and Dexamethasone Rd18 | 28.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 31.5 |
Lenalidomide and Dexamethasone Rd18 | 21.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 22.1 |
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 35.0 |
Lenalidomide and Dexamethasone Rd18 | 22.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 22.3 |
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of 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 participant was known to be alive. (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 59.1 |
Lenalidomide and Dexamethasone Rd18 | 62.3 |
Melphalan + Prednisone + Thalidomide (MPT) | 49.1 |
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 36.7 |
Lenalidomide and Dexamethasone Rd18 | 28.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
Lenalidomide and Dexamethasone Rd18 | 17.2 |
Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
Lenalidomide and Dexamethasone Rd18 | 17.2 |
Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 26.0 |
Lenalidomide and Dexamethasone Rd18 | 21.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 21.9 |
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 25.5 |
Lenalidomide and Dexamethasone Rd18 | 20.7 |
Melphalan + Prednisone + Thalidomide (MPT) | 21.2 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis 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; A PR is ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | Percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 70.0 |
Lenalidomide and Dexamethasone Rd18 | 69.7 |
Melphalan + Prednisone + Thalidomide (MPT) | 58.2 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis 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; A PR is ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
Lenalidomide and Dexamethasone Rd18 | 81.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 70.6 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis 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; A PR is ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of particpants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
Lenalidomide and Dexamethasone Rd18 | 74.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 61.0 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis 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; A PR is ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 60.5 |
Lenalidomide and Dexamethasone Rd18 | 76.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 57.5 |
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is 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; A PR is: ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 46.2 |
Lenalidomide and Dexamethasone Rd18 | 53.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 45.7 |
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is 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; A PR is: ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.7 |
Lenalidomide and Dexamethasone Rd18 | 78.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 67.5 |
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is 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; A PR is: ≥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. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 75.1 |
Lenalidomide and Dexamethasone Rd18 | 73.4 |
Melphalan + Prednisone + Thalidomide (MPT) | 62.3 |
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
Lenalidomide and Dexamethasone Rd18 | 1.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
Lenalidomide and Dexamethasone Rd18 | 1.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
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 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 2.9 | -3.3 | -8.6 | -6.4 | -5.1 | -7.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.3 | -5.9 | -9.8 | -7.3 | -8.1 | -1.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | -6.2 | -13.5 | -10.5 | -12.2 | -2.6 |
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 Cognitive 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. (NCT00689936)
Timeframe: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -1.7 | 1.8 | 0.9 | -1.2 | -2.8 | -2.6 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.2 | -0.7 | -0.9 | -1.6 | -2.2 | -4.9 |
Melphalan + Prednisone + Thalidomide (MPT) | -1.8 | -1.5 | -0.3 | -0.6 | -0.7 | -7.1 |
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 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 6.3 | 0.0 | -5.1 | -5.2 | -5.9 | -7.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 8.3 | 1.8 | -2.4 | -2.4 | -4.5 | -7.9 |
Melphalan + Prednisone + Thalidomide (MPT) | 18.4 | 13.9 | 6.8 | 3.7 | 0.0 | -2.2 |
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 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 2.3 | 3.4 | 6.0 | 9.1 | 10.9 | 6.4 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 3.8 | 3.7 | 8.2 | 11.8 | 14.8 | 10.8 |
Melphalan + Prednisone + Thalidomide (MPT) | -0.6 | -2.4 | -2.2 | -2.5 | -1.7 | -0.5 |
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 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 3.6 | -1.9 | -2.9 | -1.6 | 2.9 | 0.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.9 | -0.8 | -2.3 | -3.5 | -1.8 | -1.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 4.2 | 2.0 | 0.1 | -1.6 | 0.4 | 7.8 |
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. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 0.1 | 3.9 | 5.8 | 4.9 | 3.1 | 3.7 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.6 | 3.8 | 4.6 | 4.6 | 5.8 | 2.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 2.1 | 5.5 | 5.1 | 5.1 | -0.0 |
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 improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 4.4 | -3.4 | -5.9 | -2.3 | 0.1 | -1.6 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.6 | -2.5 | -3.7 | -4.3 | -3.1 | 0.3 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 | -1.8 | -4.5 | -3.9 | -4.3 | 2.7 |
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 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -0.3 | -0.4 | -0.3 | 1.6 | 1.8 | 0.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 1.9 | 1.4 | 0.4 | 2.0 | 1.9 |
Melphalan + Prednisone + Thalidomide (MPT) | 0.5 | 1.9 | 0.7 | 1.1 | 0.4 | 5.0 |
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 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 3.2 | -1.3 | -1.9 | 1.1 | 1.4 | -1.6 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 0.2 | -1.2 | -1.0 | -0.5 | -5.2 |
Melphalan + Prednisone + Thalidomide (MPT) | -10.5 | -8.9 | -11.6 | -9.6 | -6.0 | -4.5 |
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 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -0.5 | -2.5 | -4.0 | -3.6 | -2.7 | -4.2 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 | -1.1 | -1.3 | -2.2 | -2.3 | 0.4 |
Melphalan + Prednisone + Thalidomide (MPT) | 4.0 | -1.2 | -3.9 | -3.9 | -3.9 | 1.0 |
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 improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -4.4 | -13.1 | -16.1 | -14.7 | -12.4 | -7.9 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -5.4 | -13.4 | -14.4 | -14.0 | -14.4 | -8.0 |
Melphalan + Prednisone + Thalidomide (MPT) | -7.8 | -12.1 | -13.4 | -14.3 | -14.7 | -6.0 |
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. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -1.4 | 4.7 | 7.6 | 7.4 | 6.8 | 3.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.7 | 3.4 | 4.7 | 5.0 | 6.9 | -0.1 |
Melphalan + Prednisone + Thalidomide (MPT) | -0.9 | 2.2 | 5.3 | 6.9 | 8.3 | -0.1 |
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 Role 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. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -4.6 | 6.3 | 8.6 | 9.4 | 9.1 | 3.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -2.7 | 2.4 | 6.3 | 7.8 | 8.0 | -0.3 |
Melphalan + Prednisone + Thalidomide (MPT) | -2.4 | 4.1 | 8.2 | 11.8 | 14.5 | -1.0 |
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 Social 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. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -2.2 | 2.0 | 5.2 | 3.8 | 3.2 | 2.7 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.3 | 0.7 | 4.0 | 2.9 | 4.2 | -1.2 |
Melphalan + Prednisone + Thalidomide (MPT) | -1.4 | 2.4 | 3.4 | 5.8 | 6.0 | -3.5 |
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. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Study discontinuation | |
Lenalidomide and Dexamethasone Rd18 | -1.3 | 4.7 | 5.4 | 3.2 | 5.7 | 5.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.4 | 4.8 | 5.9 | 4.8 | 6.4 | -0.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 4.3 | 6.1 | 6.5 | 4.8 | 0.3 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -1.5 | 0.8 | 1.5 | -0.4 | -0.3 | 1.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.5 | -1.7 | -1.4 | -1.4 | -2.3 | -5.6 |
Melphalan + Prednisone + Thalidomide (MPT) | -1.6 | -3.0 | -2.8 | -2.6 | -1.1 | -5.6 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -4.1 | -10.0 | -9.9 | -8.7 | -6.2 | -4.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.0 | -9.1 | -8.8 | -7.8 | -8.7 | -3.5 |
Melphalan + Prednisone + Thalidomide (MPT) | -4.4 | -7.0 | -7.9 | -6.5 | -7.9 | -3.7 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 3.9 | 9.2 | 12.3 | 12.1 | 11.7 | 8.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 4.7 | 8.5 | 9.8 | 10.8 | 12.7 | 5.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 3.3 | 6.3 | 8.0 | 10.0 | 9.5 | 3.2 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 4.0 | 1.2 | -0.4 | 1.2 | 2.3 | -1.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.5 | 1.0 | 1.7 | 1.9 | 2.2 | 0.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 5.6 | 3.5 | 2.9 | 4.7 | 4.3 | 3.8 |
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. 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 higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. 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. (NCT00689936)
Timeframe: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | Participants (Number) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
≥ 1 adverse event (AE) | ≥ 1 grade (Gr) 3 or 4 AE | ≥ 1 grade (Gr) 5 AE | ≥ 1 serious adverse event (SAE) | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | ≥ 1 AE related to Lenalidomide | ≥ 1 AE related to dexamethasone | ≥ 1 AE related to melphalan | ≥ 1 AE related to prednisone | ≥ 1 AE related to thalidomide | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 grade 3 or 4 AE related to Lenalidomide | ≥ 1 grade 3 or 4 AE related to dexamethasone | ≥ 1 grade 3 or 4 AE related to melphalan | ≥ 1 grade 3 or 4 AE related to prednisone | ≥ 1 grade 3 or 4 AE related to Thalidomide | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Lenalidomide | ≥ 1 Grade 5 AE related to Dexamethasone | ≥ 1 Grade 5 AE related to melphalan | ≥ 1 Grade 5 AE related to prednisone | ≥ 1 Grade 5 AE related to Thalidomide | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | ≥1 SAE related to Lenalidomide | ≥1 SAE related to dexamethasone | ≥1 SAE related to melphalan | ≥1 SAE related to prednisone | ≥1 SAE related to thalidomide | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | ≥1 AE leading to Lenalidomide withdrawal | ≥1 AE leading to dexamethasone withdrawal | ≥1 AE leading to melphalan withdrawal | ≥1 AE leading to prednisone withdrawal | ≥1 AE leading to Thalidomide withdrawal | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | ≥1 AE leading to Lenalidomide reduction | ≥1 AE leading to dexamethasone reduction | ≥1 AE leading to melphalan reduction | ≥1 AE leading to prednisone reduction | ≥1 AE leading to thalidomide reduction | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | ≥1 AE leading to Rd or MPT interruption | ≥1 AE leading to Lenalidomide interruption | ≥1 AE leading to dexamethasone interruption | ≥1 AE leading to melphalan interruption | ≥1 AE leading to prednisone interruption | ≥1 AE leading to Thalidomide interruption | ≥1 AE leading to Len and Dex or MPT interruption | |
Lenalidomide and Dexamethasone Rd18 | 536 | 433 | 36 | 308 | 501 | 481 | 410 | 0 | 0 | 0 | 269 | 326 | 290 | 177 | 0 | 0 | 0 | 104 | 11 | 9 | 7 | 0 | 0 | 0 | 5 | 158 | 130 | 97 | 0 | 0 | 0 | 64 | 109 | 93 | 104 | 0 | 0 | 0 | 84 | 214 | 155 | 118 | 0 | 0 | 0 | 20 | 321 | 301 | 280 | 0 | 0 | 0 | 241 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 529 | 453 | 50 | 359 | 506 | 482 | 429 | 0 | 0 | 0 | 269 | 373 | 342 | 229 | 0 | 0 | 0 | 131 | 17 | 12 | 16 | 0 | 0 | 0 | 11 | 195 | 165 | 130 | 0 | 0 | 0 | 95 | 157 | 109 | 152 | 0 | 0 | 0 | 96 | 279 | 203 | 170 | 0 | 0 | 0 | 30 | 368 | 353 | 319 | 0 | 0 | 0 | 290 |
Melphalan + Prednisone + Thalidomide (MPT) | 539 | 480 | 38 | 270 | 527 | 0 | 0 | 441 | 326 | 493 | 145 | 423 | 0 | 0 | 307 | 118 | 316 | 49 | 10 | 0 | 0 | 6 | 5 | 5 | 2 | 142 | 0 | 0 | 75 | 62 | 94 | 27 | 153 | 0 | 0 | 83 | 78 | 146 | 71 | 348 | 0 | 0 | 199 | 47 | 254 | 2 | 419 | 0 | 0 | 328 | 324 | 388 | 249 |
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline Grade | Grade 4 Baseline to Grade 1 postbaseline Grade | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline Grade to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline | |
Lenalidomide and Dexamethasone Rd18 | 133 | 85 | 109 | 71 | 30 | 6 | 11 | 15 | 30 | 4 | 0 | 1 | 11 | 18 | 5 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 103 | 96 | 121 | 70 | 21 | 7 | 8 | 17 | 25 | 9 | 1 | 1 | 14 | 18 | 9 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
Melphalan + Prednisone + Thalidomide (MPT) | 37 | 79 | 128 | 141 | 45 | 2 | 2 | 11 | 20 | 21 | 0 | 1 | 7 | 21 | 10 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CrCl< 30 mL/min to CrCl< 30 mL/min | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl< 30 mL/min to ≥ 80 mL/min | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min | |
Lenalidomide and Dexamethasone Rd18 | 17 | 14 | 8 | 2 | 2 | 41 | 55 | 12 | 0 | 1 | 130 | 99 | 1 | 0 | 10 | 114 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 15 | 18 | 7 | 2 | 1 | 37 | 67 | 9 | 0 | 4 | 112 | 107 | 0 | 0 | 6 | 109 |
Melphalan + Prednisone + Thalidomide (MPT) | 19 | 19 | 5 | 0 | 0 | 41 | 65 | 2 | 0 | 4 | 102 | 97 | 0 | 0 | 9 | 121 |
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade 1 Baseline to Grade 1 postbaseline | Grade1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline | Grade 4 Baseline to Grade 1 postbaseline | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline | |
Lenalidomide and Dexamethasone Rd18 | 10 | 30 | 8 | 1 | 0 | 0 | 126 | 123 | 17 | 5 | 0 | 12 | 135 | 41 | 9 | 0 | 1 | 4 | 8 | 3 | 0 | 0 | 0 | 1 | 1 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 6 | 39 | 8 | 0 | 0 | 0 | 106 | 128 | 25 | 2 | 0 | 8 | 125 | 48 | 4 | 0 | 0 | 12 | 10 | 5 | 0 | 0 | 0 | 0 | 1 |
Melphalan + Prednisone + Thalidomide (MPT) | 9 | 25 | 4 | 1 | 0 | 0 | 110 | 123 | 20 | 4 | 0 | 14 | 133 | 47 | 11 | 0 | 0 | 10 | 10 | 2 | 0 | 0 | 1 | 0 | 2 |
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade1 Baseline to Normal postbaseline Grade | Grade 1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline Grade | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline Grade | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline | |
Lenalidomide and Dexamethasone Rd18 | 197 | 211 | 30 | 12 | 5 | 3 | 38 | 19 | 12 | 1 | 0 | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 1 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 197 | 216 | 24 | 15 | 4 | 1 | 34 | 15 | 10 | 2 | 0 | 0 | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 2 |
Melphalan + Prednisone + Thalidomide (MPT) | 165 | 208 | 27 | 31 | 11 | 6 | 51 | 7 | 10 | 1 | 0 | 2 | 1 | 2 | 2 | 0 | 0 | 1 | 1 | 0 |
The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline. (NCT00065156)
Timeframe: Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)
Intervention | g/dL (Mean) |
---|---|
Lenalidomide | 6.1 |
Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence. (NCT00065156)
Timeframe: up to 2 years
Intervention | weeks (Median) |
---|---|
Lenalidomide | 97.0 |
"Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin." (NCT00065156)
Timeframe: Up to 2 years
Intervention | participants (Number) |
---|---|
Lenalidomide | 59 |
A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment). (NCT00065156)
Timeframe: Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)
Intervention | participant (Number) |
---|---|
Lenalidomide | 70 |
"Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period." (NCT00065156)
Timeframe: up to 2 years
Intervention | weeks (Mean) |
---|---|
Lenalidomide | 6.2 |
"Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of~≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days." (NCT00065156)
Timeframe: up to 2 years
Intervention | participant (Number) | ||
---|---|---|---|
Major | Minor | None | |
Lenalidomide | 9 | 0 | 18 |
"Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least~1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline." (NCT00065156)
Timeframe: up to 2 years
Intervention | participants (Number) | ||
---|---|---|---|
Major | Minor | None | |
Lenalidomide | 18 | 20 | 14 |
"Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.~Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions." (NCT00065156)
Timeframe: up to 2 years
Intervention | participants (Number) | ||
---|---|---|---|
Major | Minor | None | |
Lenalidomide | 2 | 0 | 13 |
"Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study." (NCT00065156)
Timeframe: up to 2 years
Intervention | participants (Number) | |
---|---|---|
Relapsed (had a transfusion after response) | Maintained transfusion independence | |
Lenalidomide | 35 | 24 |
"Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE." (NCT00065156)
Timeframe: Up to 2 Years
Intervention | participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
At least one AE | At least one AE related to study drug | At least one NCI CTC grade 3-4 AE | At least one NCI CTC grade 3-4 AE related to drug | At least one serious AE | At least one serious AE related to study drug | AE leading to dose reduction or interruption | AE leading to discontinuation of study drug | |
Lenalidomide | 148 | 143 | 140 | 131 | 89 | 40 | 131 | 47 |
"Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):~Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).~Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML)." (NCT00065156)
Timeframe: up to 2 years
Intervention | participants (Number) | |
---|---|---|
RA/RARS to RAEB | RA/RARS/RAEB/CMML to AML | |
Lenalidomide | 11 | 6 |
Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist. (NCT00065156)
Timeframe: up to 2 years
Intervention | participants (Number) | |
---|---|---|
Complete bone marrow improvement | Partial bone marrow improvement | |
Lenalidomide | 22 | 15 |
Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels. (NCT00142168)
Timeframe: 34.3 months
Intervention | participants (Number) |
---|---|
Lenalidomide and Rituximab | 4 |
A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels. (NCT00142168)
Timeframe: 34.3 months
Intervention | participants (Number) |
---|---|
Lenalidomide and Rituximab | 4 |
Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study. (NCT00142168)
Timeframe: 34.3 months
Intervention | participants (Number) |
---|---|
Lenalidomide and Rituximab | 8 |
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir. (NCT00142168)
Timeframe: 34.3 months
Intervention | months (Median) |
---|---|
Lenalidomide and Rituximab | 17.1 |
Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death. (NCT00352794)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|---|
Lenalidomide + Prednisone | 14 |
"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." (NCT00179673)
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide | 23.3 |
"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." (NCT00179673)
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide | 60.5 |
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. (NCT00179673)
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months
Intervention | months (Median) |
---|---|
Lenalidomide | 4.4 |
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. (NCT00179673)
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months
Intervention | months (Median) |
---|---|
Lenalidomide | NA |
"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." (NCT00179673)
Timeframe: From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.
Intervention | participants (Number) | ||||||||
---|---|---|---|---|---|---|---|---|---|
At least one Adverse Event (AE) | ≥ 1 AE related to study drug | Grade (GR) 3-5 AE | Grade 3-5 AE related to study drug | Serious adverse event (SAE) | SAE 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 | 42 | 37 | 27 | 24 | 18 | 10 | 9 | 5 | 27 |
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method. (NCT00478218)
Timeframe: up to 5 years
Intervention | months (Median) |
---|---|
LCD (Cyclophosphamide 300 mg/m^2) | 26.1 |
LCD (Cyclophosphamide 300 mg) | NA |
"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels" (NCT00478218)
Timeframe: Duration of Treatment (up to 5 years)
Intervention | participants (Number) |
---|---|
LCD (Cyclophosphamide 300 mg/m^2) | 28 |
LCD (Cyclophosphamide 300 mg) | 16 |
OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method. (NCT00478218)
Timeframe: up to 5 years
Intervention | months (Median) |
---|---|
LCD (Cyclophosphamide 300 mg/m^2) | NA |
LCD (Cyclophosphamide 300 mg) | NA |
"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.> Progression was defined as any one or more of the following:> An increase of 25% from lowest confirmed response in:>~Serum M-component (absolute increase >= 0.5g/dl)>~Urine M-component (absolute increase >= 200mg/24hour>~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl>~Bone marrow plasma cell percentage (absolute increase of >=10%)" (NCT00478218)
Timeframe: up to 5 years
Intervention | months (Median) |
---|---|
LCD (Cyclophosphamide 300 mg/m^2) | 27 |
LCD (Cyclophosphamide 300 mg) | NA |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 0.4 |
Lenalidomide - Subpopulation From UK + Ireland | 3.3 |
Lenalidomide - Subpopulation From Spain | -4.5 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -1.9 |
Lenalidomide - Subpopulation From UK + Ireland | -4.9 |
Lenalidomide - Subpopulation From Spain | 3.5 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 1.1 |
Lenalidomide - Subpopulation From UK + Ireland | 7.9 |
Lenalidomide - Subpopulation From Spain | 2.6 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 8.6 |
Lenalidomide - Subpopulation From UK + Ireland | 8.1 |
Lenalidomide - Subpopulation From Spain | 9.0 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 2.7 |
Lenalidomide - Subpopulation From UK + Ireland | 2.7 |
Lenalidomide - Subpopulation From Spain | -0.9 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -0.2 |
Lenalidomide - Subpopulation From UK + Ireland | -4.0 |
Lenalidomide - Subpopulation From Spain | -0.7 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 2.6 |
Lenalidomide - Subpopulation From UK + Ireland | 5.3 |
Lenalidomide - Subpopulation From Spain | 1.0 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 2.0 |
Lenalidomide - Subpopulation From UK + Ireland | 0.8 |
Lenalidomide - Subpopulation From Spain | 0.9 |
EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 1.1 |
Lenalidomide - Subpopulation From UK + Ireland | -1.8 |
Lenalidomide - Subpopulation From Spain | -2.2 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -3.8 |
Lenalidomide - Subpopulation From UK + Ireland | 2.2 |
Lenalidomide - Subpopulation From Spain | -1.8 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 1.0 |
Lenalidomide - Subpopulation From UK + Ireland | 0.1 |
Lenalidomide - Subpopulation From Spain | -2.2 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -3.9 |
Lenalidomide - Subpopulation From UK + Ireland | -5.2 |
Lenalidomide - Subpopulation From Spain | -6.6 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -3.6 |
Lenalidomide - Subpopulation From UK + Ireland | -2.9 |
Lenalidomide - Subpopulation From Spain | -1.8 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -2.4 |
Lenalidomide - Subpopulation From UK + Ireland | -1.5 |
Lenalidomide - Subpopulation From Spain | -2.6 |
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -5.2 |
Lenalidomide - Subpopulation From UK + Ireland | -5.3 |
Lenalidomide - Subpopulation From Spain | -3.1 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -4.3 |
Lenalidomide - Subpopulation From UK + Ireland | -2.0 |
Lenalidomide - Subpopulation From Spain | -5.3 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | -2.4 |
Lenalidomide - Subpopulation From UK + Ireland | -1.2 |
Lenalidomide - Subpopulation From Spain | -3.9 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 5.8 |
Lenalidomide - Subpopulation From UK + Ireland | 3.4 |
Lenalidomide - Subpopulation From Spain | 4.4 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. (NCT00420849)
Timeframe: Baseline (Day 0), Week 24
Intervention | units on a scale (Mean) |
---|---|
Lenalidomide - Subpopulation From Austria + Australia | 4.9 |
Lenalidomide - Subpopulation From UK + Ireland | 4.7 |
Lenalidomide - Subpopulation From Spain | 2.0 |
Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants. (NCT00420849)
Timeframe: up to 124 weeks
Intervention | weeks (Mean) |
---|---|
Lenalidomide Plus Dexamethasone | 25.6 |
Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants. (NCT00420849)
Timeframe: up to 124 weeks
Intervention | weeks (Mean) |
---|---|
Lenalidomide Plus Dexamethasone | 26.5 |
"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death." (NCT00420849)
Timeframe: up to 123 weeks
Intervention | participants (Number) | |||
---|---|---|---|---|
At least one treatment-emergent AE (TEAE) | At least one TEAE related to study drug | At least one TEAE with severity grade of 3 or 4 | At least one serious AE (SAE) | |
Lenalidomide Plus Dexamethasone | 586 | 519 | 471 | 340 |
Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category. (NCT00420849)
Timeframe: up to 124 weeks
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
At least one TEAE of peripheral neuropathy | Neuropathy peripheral | Peripheral sensory neuropathy | Neuralgia | Peripheral motor neuropathy | Polyneuropathy | Sensory disturbance | |
Lenalidomide Plus Dexamethasone | 84 | 46 | 33 | 5 | 2 | 2 | 1 |
Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category. (NCT00420849)
Timeframe: up to 124 weeks
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
At least one venous thromboembolic event | Deep vein thrombosis | Pulmonary embolism | Thrombophlebitis | Venous thrombosis limb | |
Lenalidomide Plus Dexamethasone | 60 | 38 | 23 | 7 | 1 |
"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: Up to 149 weeks
Intervention | weeks (Median) |
---|---|
MPR+R | 121.6 |
MPR+p | 56.1 |
MPp+p | 55.4 |
Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00405756)
Timeframe: Up to 168 weeks
Intervention | weeks (Median) |
---|---|
MPR+R | 128.9 |
MPR+p | 66.1 |
MPp+p | 66.3 |
Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. 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 available, or clinical cut-off date, if it was earlier. (NCT00405756)
Timeframe: up to 177 weeks
Intervention | weeks (Median) |
---|---|
MPR+R | NA |
MPR+p | NA |
MPp+p | NA |
"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: up to 165 weeks
Intervention | weeks (Median) |
---|---|
MPR+R | 136.1 |
MPR+p | 62.1 |
MPp+p | 56.1 |
"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.~PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: Approximately week 37 (start of cycle 10) to week 165
Intervention | weeks (Median) |
---|---|
MPR+R | 112.0 |
MPR+p | 32.3 |
"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: up to 165 weeks
Intervention | weeks (Median) |
---|---|
MPR+R | 148.1 |
MPR+p | 62.7 |
MPp+p | 61.3 |
Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria. (NCT00405756)
Timeframe: Up to 66 weeks
Intervention | weeks (Mean) |
---|---|
MPR+R | 10.0 |
MPR+p | 9.3 |
MPp+p | 16.2 |
Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=114,121,125) | Cycle 7 - approximately Month 7 (n=96,108,110) | Cycle 10 - approximately Month 10 (n=84,86,96) | Cycle 13 - approximately Month 13 (n=70,70,82) | Cycle 16 - approximately Month 16 (n=61,50,62) | |
MPp+p | 6.1 | 4.2 | 6.2 | 5.4 | 8.1 |
MPR+p | 5.6 | 8.1 | 8.8 | 8.8 | 7.2 |
MPR+R | 2.3 | 8.0 | 12.4 | 7.6 | 10.7 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=119,125,130) | Cycle 7 - approximately Month 7 (n=99,111,111) | Cycle 10 - approximately Month 10 (n=87,93,96) | Cycle 13 - approximately Month 13 (n=75,72,83) | Cycle 16 - approximately Month 16 (n=64,52,63) | |
MPp+p | -5.6 | -5.7 | -8.0 | -4.8 | -6.4 |
MPR+p | 1.9 | -5.7 | -5.4 | -8.8 | -16.0 |
MPR+R | 1.7 | -3.7 | -5.0 | -6.2 | -7.8 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=115,125,128) | Cycle 7 - approximately Month 7 (n=98,111,113) | Cycle 10 - approximately Month 10 (n=87,92,97) | Cycle 13 - approximately Month 13 (n=73,73,83) | Cycle 16 - approximately Month 16 (n=63,52,63) | |
MPp+p | 1.3 | 0.7 | -2.7 | -1.4 | -4.0 |
MPR+p | -2.0 | 0.1 | -4.4 | -3.0 | -3.5 |
MPR+R | 0.3 | 2.9 | 1.0 | -0.0 | 0.3 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=114,124,128) | Cycle 7 - approximately Month 7 (n=96,111,112) | Cycle 10 - approximately Month 10 (n=86,93,97) | Cycle 13 - approximately Month 13 (n=73,73,81) | Cycle 16 - approximately Month 16 (n=63,51,62) | |
MPp+p | -4.9 | -2.7 | -1.7 | -3.3 | -2.2 |
MPR+p | 4.8 | 0.6 | -1.1 | -2.7 | -5.2 |
MPR+R | -1.8 | -3.5 | -5.0 | -5.0 | -1.6 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=115,125,124) | Cycle 7 - approximately Month 7 (n=98,109,112) | Cycle 10 - approximately Month 10 (n=87,92,95) | Cycle 13 - approximately Month 13 (n=73,73,80) | Cycle 16 - approximately Month 16 (n=63,52,61) | |
MPp+p | 3.2 | 0.9 | -0.0 | 0.8 | 0.5 |
MPR+p | 1.9 | -1.2 | 1.4 | -1.4 | 1.3 |
MPR+R | 2.3 | 3.4 | 1.1 | 5.5 | 10.6 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=117,126,126) | Cycle 7 - approximately Month 7 (n=100,110,110) | Cycle 10 - approximately Month 10 (n=86,93,96) | Cycle 13 - approximately Month 13 (n=73,73,81) | Cycle 16 - approximately Month 16 (n=62,53,62) | |
MPp+p | -0.0 | 2.1 | 3.8 | -0.0 | 1.6 |
MPR+p | -6.4 | -8.5 | -4.3 | -2.3 | -6.3 |
MPR+R | -2.6 | -1.7 | -4.3 | -5.0 | -3.2 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=115,125,128) | Cycle 7 - approximately Month 7 (n=98,111,112) | Cycle 10 - approximately Month 10 (n=86,92,97) | Cycle 13 - approximately Month 13 (n=73,73,83) | Cycle 16 - approximately Month 16 (n=63,52,63) | |
MPp+p | 6.8 | 5.0 | 4.7 | 6.6 | 6.9 |
MPR+p | 2.7 | 4.2 | 1.6 | 1.1 | -0.2 |
MPR+R | 4.8 | 8.8 | 9.0 | 8.2 | 9.9 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=120,127,129) | Cycle 7 - approximately Month 7 (n=100,112,110) | Cycle 10 - approximately Month 10 (n=87,95,95) | Cycle 13 - approximately Month 13 (n=74,74,82) | Cycle 16 - approximately Month 16 (n=64,53,62) | |
MPp+p | -5.1 | -5.7 | -6.9 | -7.5 | -4.1 |
MPR+p | -5.5 | -9.5 | -7.5 | -10.7 | -9.7 |
MPR+R | -3.0 | -7.6 | -7.5 | -7.1 | -10.0 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=111,123,125) | Cycle 7 - approximately Month 7 (n=94,111,112) | Cycle 10 - approximately Month 10 (n=84,92,97) | Cycle 13 - approximately Month 13 (n=70,72,83) | Cycle 16 - approximately Month 16 (n=61,52,63) | |
MPp+p | -2.9 | -2.1 | -1.7 | -4.0 | -5.3 |
MPR+p | -1.1 | -0.6 | 0.7 | -0.5 | -0.6 |
MPR+R | 2.4 | 2.1 | 6.0 | 4.8 | 1.6 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=118,124,128) | Cycle 7 - approximately Month 7 (n=100,109,111) | Cycle 10 - approximately Month 10 (n=87,94,96) | Cycle 13 - approximately Month 13 (n=75,73,83) | Cycle 16 - approximately Month 16 (n=64,53,63) | |
MPp+p | -5.0 | -5.7 | -1.7 | -6.8 | -3.7 |
MPR+p | -1.6 | -6.4 | -2.5 | 0.9 | -0.6 |
MPR+R | 2.0 | -1.0 | -5.0 | -4.9 | -4.7 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=120,127,130) | Cycle 7 - approximately Month 7 (n=99,112,112) | Cycle 10 - approximately Month 10 (n=87,95,97) | Cycle 13 - approximately Month 13 (n=75,72,83) | Cycle 16 - approximately Month 16 (n=64,52,62) | |
MPp+p | -0.0 | 0.7 | 0.3 | -0.4 | -1.3 |
MPR+p | -1.3 | -0.7 | -1.4 | -3.0 | -4.2 |
MPR+R | 3.3 | 0.5 | 1.9 | 0.7 | 1.0 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=120,127,129) | Cycle 7 - approximately Month 7 (n=100,112,113) | Cycle 10 - approximately Month 10 (n=88,95,97) | Cycle 13 - approximately Month 13 (n=74,74,83) | Cycle 16 - approximately Month 16 (n=64,53,63) | |
MPp+p | -13.4 | -11.5 | -9.8 | -12.1 | -12.2 |
MPR+p | -13.8 | -16.5 | -15.6 | -14.9 | -11.0 |
MPR+R | -14.4 | -17.8 | -17.2 | -13.7 | -20.3 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=120,127,130) | Cycle 7 - approximately Month 7 (n=100,112,112) | Cycle 10 - approximately Month 10 (n=88,95,96) | Cycle 13 - approximately Month 13 (n=75,74,83) | Cycle 16 - approximately Month 16 (n=64,53,63) | |
MPp+p | 4.5 | 2.7 | 5.1 | 3.3 | 1.1 |
MPR+p | 3.3 | 8.1 | 8.5 | 9.7 | 7.6 |
MPR+R | 1.9 | 8.2 | 8.9 | 8.6 | 10.0 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=119,127,130) | Cycle 7 - approximately Month 7 (n=99,112,113) | Cycle 10 - approximately Month 10 (n=86,95,95) | Cycle 13 - approximately Month 13 (n=74,74,82) | Cycle 16 - approximately Month 16 (n=64,53,63) | |
MPp+p | 7.4 | 6.9 | 5.6 | 5.7 | 7.1 |
MPR+p | 3.0 | 8.0 | 7.5 | 11.7 | 8.5 |
MPR+R | 1.8 | 5.7 | 9.3 | 9.7 | 12.2 |
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=115,125,127) | Cycle 7 - approximately Month 7 (n=98,111,112) | Cycle 10 - approximately Month 10 (n=87,92,97) | Cycle 13 - approximately Month 13 (n=72,73,83) | Cycle 16 - approximately Month 16 (n=63,52,63) | |
MPp+p | 6.0 | 6.1 | 4.1 | 6.2 | 9.8 |
MPR+p | 0.3 | 4.4 | 4.5 | 7.5 | 6.1 |
MPR+R | 5.1 | 8.3 | 10.9 | 11.8 | 13.2 |
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=113,121,127) | Cycle 7 - approximately Month 7 (n=96,109,112) | Cycle 10 - approximately Month 10 (n=85,91,95) | Cycle 13 - approximately Month 13 (n=72,73,82) | Cycle 16 - approximately Month 16 (n=62,51,62) | |
MPp+p | -5.4 | -6.0 | -5.4 | -6.3 | -3.3 |
MPR+p | -8.7 | -9.7 | -7.1 | -8.8 | -5.9 |
MPR+R | -8.9 | -9.0 | -7.9 | -7.2 | -10.5 |
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=110,117,119) | Cycle 7 - approximately Month 7 (n=88,104,108) | Cycle 10 - approximately Month 10 (n=79,83,94) | Cycle 13 - approximately Month 13 (n=68,72,79) | Cycle 16 - approximately Month 16 (n=59,52,61) | |
MPp+p | 4.5 | 5.2 | 3.9 | 5.1 | 2.7 |
MPR+p | -0.3 | 2.6 | -4.0 | -0.5 | 6.4 |
MPR+R | 2.1 | 3.8 | 7.6 | 1.0 | 3.4 |
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=112,121,124) | Cycle 7 - approximately Month 7 (n=93,108,112) | Cycle 10 - approximately Month 10 (n=83,88,97) | Cycle 13 - approximately Month 13 (n=71,73,81) | Cycle 16 - approximately Month 16 (n=62,52,62) | |
MPp+p | 7.6 | 9.8 | 14.5 | 11.9 | 14.4 |
MPR+p | 4.3 | 7.7 | 6.6 | 6.3 | 7.7 |
MPR+R | 4.7 | 14.6 | 17.3 | 17.3 | 18.5 |
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Cycle 4 - approximately Month 4 (n=113,120,125) | Cycle 7 - approximately Month 7 (n=95,108,111) | Cycle 10 - approximately Month 10 (n=85,89,94) | Cycle 13 - approximately Month 13 (n=72,72,81) | Cycle 16 - approximately Month 16 (n=62,50,61) | |
MPp+p | 0.6 | 1.8 | 0.3 | 0.3 | -0.9 |
MPR+p | 0.1 | -1.7 | 0.0 | -1.0 | -2.9 |
MPR+R | 1.3 | 0.4 | -1.6 | -3.8 | -2.1 |
Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE). (NCT00405756)
Timeframe: Up to 165 weeks
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) | Response not evaluable (NE) | |
MPp+p | 5 | 72 | 70 | 0 | 7 |
MPR+p | 5 | 99 | 40 | 2 | 7 |
MPR+R | 15 | 102 | 28 | 0 | 7 |
Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption. (NCT00405756)
Timeframe: Up to 169 weeks (Double-blind therapy period plus 4 weeks)
Intervention | participants (Number) | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
>=1 adverse event (AE) | >=1 CTCAE grade 3-4 AE | >=1 CTCAE grade 5 AE | >=1 serious AE (SAE) | >=1 AE related to Lenaldomide/Placebo | >=1 AE related to Melphalan | >=1AE related to Prednisone | >=1 Grade 3-4 AE related to Lenaldomide/Placebo | >=1 Grade 3-4 AE related to Melphalan | >=1 Grade 3-4 AE related to Prednisone | >=1 Grade 5 AE related to Lenalidomide/Placebo | >=1 Grade 5 AE related to Melphalan | >=1 Grade 5 AE related to Prednisone | >=1 SAE related to Lenalidomide/Placebo | >=1 SAE related to Melphalan | >=1 SAE related to Prednisone | >=1 AE leading to Lenalidomide/Placebo withdrawal | >=1 AE leading to Melphalan withdrawal | >=1 AE leading to Prednisone withdrawal | >=1 AE leading to Lenalidomide/Plac dose reduction | >=1 AE leading to Melphalan dose reduction | >=1 AE leading to Prednisone dose reduction | >=1 AE leading to Lenalidomide/Plac dose interrupt | >=1 AE leading to Melphalan dose interruption | >=1 AE leading to Prednisone dose interruption | |
MPp+p | 153 | 107 | 7 | 56 | 131 | 126 | 93 | 68 | 62 | 22 | 2 | 3 | 1 | 11 | 11 | 5 | 14 | 10 | 10 | 26 | 21 | 5 | 51 | 0 | 15 |
MPR+p | 151 | 129 | 6 | 62 | 145 | 134 | 94 | 117 | 110 | 29 | 2 | 1 | 1 | 32 | 24 | 16 | 24 | 19 | 19 | 70 | 58 | 7 | 82 | 1 | 39 |
MPR+R | 150 | 137 | 7 | 66 | 148 | 140 | 87 | 128 | 118 | 32 | 3 | 3 | 1 | 38 | 27 | 19 | 26 | 20 | 20 | 71 | 47 | 15 | 92 | 5 | 28 |
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 |
Assessed by the investigator per International Myeloma Working Group criteria(IMWG) uniform response criteria. Result reflects number of participants whose best overall response qualified as sCR, CR, or VGPR in 2 year follow up period. (NCT02906332)
Timeframe: Every 3 weeks (day 1 of every 21-day treatment cycle +/- 7 days) through 12 weeks.
Intervention | Participants (Count of Participants) |
---|---|
Pembrolizumab + Lenalidomide | 11 |
Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received pembrolizumab (MK-3475), lenalidomide and dexamethasone, including serious adverse events (SAEs). Result reflects count of participants who experienced an SAE. (NCT02906332)
Timeframe: Up to 3 years
Intervention | Participants (Count of Participants) |
---|---|
Pembrolizumab + Lenalidomide | 1 |
Assessed at 12 months; Subjects without documented PD or death will be censored at the last disease assessment date. Those who died without documented PD will be censored at the time of death. Result reflects count of participants who had progressed at 12 months. (NCT02906332)
Timeframe: Time from Day 0 (transplant) and date of enrollment to study completion (through 12 weeks) by investigator assessment.
Intervention | Participants (Count of Participants) |
---|---|
Pembrolizumab + Lenalidomide | 10 |
PFS will be assessed from the date of ASCT, with day 0 defined as date of stem cell infusion (if tandem transplant the 2nd of 2 transplants will be used) until the date of progression, defined as the date at which the patient starts the next line of therapy or the date of death. (NCT02906332)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|---|
Pembrolizumab + Lenalidomide | 27.6 |
CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) |
---|---|
Cohort 1 | 0 |
Cohort 2 | 4 |
Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells). (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) |
---|---|
Cohort 1 | 1 |
Cohort 2 | 3 |
Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence (NCT00546897)
Timeframe: 2 years
Intervention | months (Median) |
---|---|
Cohort 2 | 10 |
CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) |
---|---|
Cohort 1 | 0 |
Cohort 2 | 3 |
Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) |
---|---|
Cohort 1 | 1 |
Cohort 2 | 10 |
Overall survival: Defined as the date of first dose of study drug to the date of death from any cause. (NCT00546897)
Timeframe: 2 years
Intervention | months (Median) |
---|---|
Cohort 2 | 4 |
Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) |
---|---|
Cohort 1 | 1 |
Cohort 2 | 0 |
Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is. (NCT00546897)
Timeframe: 2 years
Intervention | months (Median) |
---|---|
Cohort 2 | 2 |
This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause. (NCT00546897)
Timeframe: 2 years
Intervention | months (Median) |
---|---|
Cohort 2 | 10 |
Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting (NCT00546897)
Timeframe: 4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]
Intervention | participants (Number) |
---|---|
Cohort 1 | 1 |
Cohort 2 | 8 |
"CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells)." (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) | ||
---|---|---|---|
CRm | CRi | CRc | |
Cohort 1 | 0 | 0 | 1 |
Cohort 2 | 3 | 4 | 3 |
"RR = as patients obtaining any response (CRm + CRc +CRi + PR).~CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Partial remission (PR): Requires" (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)
Intervention | participants (Number) | |||
---|---|---|---|---|
CRm | CRc | CRi | PR | |
Cohort 1 | 0 | 1 | 0 | 1 |
Cohort 2 | 3 | 3 | 4 | 0 |
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 |
12 reviews available for thalidomide and Neutropenia
Article | Year |
---|---|
Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma.
Topics: Antibodies, Monoclonal; Bortezomib; Dexamethasone; Disease-Free Survival; Drug Administration Schedu | 2017 |
Lenalidomide in combination or alone as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma: a review of options for and against.
Topics: Clinical Trials as Topic; Drug Therapy, Combination; Hematopoietic Stem Cell Transplantation; Humans | 2017 |
Expert panel consensus statement on the optimal use of pomalidomide in relapsed and refractory multiple myeloma.
Topics: Age Factors; Clinical Trials as Topic; Dexamethasone; Drug Administration Schedule; Humans; Immunolo | 2014 |
Bortezomib-thalidomide-based regimens improved clinical outcomes without increasing toxicity as induction treatment for untreated multiple myeloma: a meta-analysis of phase III randomized controlled trials.
Topics: Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Trials, Phase II | 2014 |
[Pomalidomide in the treatment of relapsed and refractory multiple myeloma].
Topics: Administration, Oral; Boronic Acids; Bortezomib; Dexamethasone; Disease-Free Survival; Humans; Immun | 2014 |
Maintenance Therapy With Immunomodulatory Drugs in Multiple Myeloma: A Meta-Analysis and Systematic Review.
Topics: Disease-Free Survival; Humans; Immunosuppressive Agents; Infections; Lenalidomide; Maintenance Chemo | 2016 |
New immunomodulatory drugs in myeloma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Immunologic Factors; Lenalido | 2011 |
Management of the adverse effects of lenalidomide in multiple myeloma.
Topics: Anemia; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillation; | 2011 |
Role of lenalidomide in the treatment of myelodysplastic syndromes.
Topics: Anemia, Macrocytic; Antineoplastic Agents; Chromosome Deletion; Chromosomes, Human, Pair 5; Clinical | 2011 |
Adverse effects of thalidomide administration in patients with neoplastic diseases.
Topics: Angiogenesis Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Clinical Trials, Phase II | 2004 |
Immunomodulatory drugs in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Animals; Apoptosis; Blood Transfusion; Cell | 2006 |
Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma.
Topics: Anorexia; Antineoplastic Agents; Apoptosis; Constipation; Diarrhea; Drug Eruptions; Drug Monitoring; | 2007 |
57 trials available for thalidomide and Neutropenia
Article | Year |
---|---|
Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial.
Topics: Aminopyridines; Antineoplastic Combined Chemotherapy Protocols; Benzamides; Etoposide; Humans; Lymph | 2022 |
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 |
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 |
EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma.
Topics: Adult; Antibodies, Monoclonal, Humanized; Dexamethasone; Humans; Multiple Myeloma; Neutropenia; Thal | 2021 |
Lenalidomide Maintenance Compared With Placebo in Responding Elderly Patients With Diffuse Large B-Cell Lymphoma Treated With First-Line Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
Topics: Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherap | 2017 |
Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Disease-Free Su | 2017 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva | 2018 |
Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemother | 2018 |
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 |
Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Carcinom | 2015 |
Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Carcinom | 2015 |
Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Carcinom | 2015 |
Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Antineoplastic Agents; Carcinom | 2015 |
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 |
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 |
Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Disease-Free | 2014 |
Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Disease-Free | 2014 |
Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Disease-Free | 2014 |
Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Disease-Free | 2014 |
A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma.
Topics: Adult; Aged; Alanine Transaminase; Antineoplastic Combined Chemotherapy Protocols; Aspartate Aminotr | 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 |
Autologous transplantation and maintenance therapy in multiple myeloma.
Topics: Adult; Aged; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Comb | 2014 |
A phase I study of bendamustine, lenalidomide and rituximab in relapsed and refractory lymphomas.
Topics: Adult; Aged; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols; | 2015 |
A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer.
Topics: Adenocarcinoma; Administration, Oral; Aged; Anticoagulants; Antineoplastic Combined Chemotherapy Pro | 2015 |
Lenalidomide is safe and active in Waldenström macroglobulinemia.
Topics: Administration, Oral; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Drug Administration Sc | 2015 |
Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chem | 2015 |
Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study.
Topics: Adult; Angiogenesis Inhibitors; Humans; Lenalidomide; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, T-C | 2016 |
VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial.
Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Cyclophosphamide; D | 2016 |
Results of a phase II study of lenalidomide and rituximab for refractory/relapsed chronic lymphocytic leukemia.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Schedule; Female; H | 2016 |
A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher-risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia.
Topics: Aged; Aged, 80 and over; Female; Humans; Lenalidomide; Leukemia, Myeloid, Acute; Male; Middle Aged; | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
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 |
Relationship of treatment-related cytopenias and response to lenalidomide in patients with lower-risk myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Erythrocyte Transfusion; Female; Humans; Lena | 2008 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma.
Topics: Administration, Oral; Aged; Aged, 80 and over; Antineoplastic Agents; Disease-Free Survival; Drug Ad | 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 |
Melphalan, prednisone, and lenalidomide for newly diagnosed myeloma: kinetics of neutropenia and thrombocytopenia and time-to-event results.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Dose-Response Relations | 2009 |
Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Drug Therapy, Combination; Enzyme-Lin | 2009 |
Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's Lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Constipation; Diarrhea; | 2009 |
A modular Phase I study of lenalidomide and paclitaxel in metastatic castration-resistant prostate cancer following prior taxane therapy.
Topics: Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bridged-Ring Compounds; Combined Modal | 2010 |
Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis.
Topics: Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Disease-Free Survival; Female; Humans; Lenal | 2010 |
Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Kaplan-Meie | 2010 |
Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Kaplan-Meie | 2010 |
Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Kaplan-Meie | 2010 |
Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Kaplan-Meie | 2010 |
Lenalidomide monotherapy for relapsed/refractory peripheral T-cell lymphoma not otherwise specified.
Topics: Administration, Oral; Aged; Aged, 80 and over; Antineoplastic Agents; Dose-Response Relationship, Dr | 2011 |
A prospective clinical trial of lenalidomide with topotecan in women with advanced epithelial ovarian carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dose-Response Relationship, Drug; Drug- | 2011 |
Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma: results from a phase 2 trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Antineopla | 2011 |
Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.
Topics: Adjuvants, Immunologic; Adult; Aged; Aged, 80 and over; Allopurinol; Antimetabolites, Antineoplastic | 2012 |
Phase II trial of the pan-deacetylase inhibitor panobinostat as a single agent in advanced relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Antineoplastic Agents; Area Under Curve; Boronic Acids; Bortezomib; Diarrhea; Drug Admi | 2012 |
Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disea | 2012 |
Phase II study of melphalan, thalidomide and prednisone combined with oral panobinostat in patients with relapsed/refractory multiple myeloma.
Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Dose | 2012 |
Continuous lenalidomide treatment for newly diagnosed multiple myeloma.
Topics: Administration, Oral; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disea | 2012 |
Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus.
Topics: Administration, Oral; Adult; Diarrhea; Drug Resistance; Female; Humans; Immunologic Factors; Lenalid | 2012 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.
Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot | 2002 |
[Single-agent thalidomide for advanced and refractory multiple myeloma].
Topics: Aged; Aged, 80 and over; Constipation; Disease Progression; Disorders of Excessive Somnolence; Femal | 2003 |
Thalidomide-induced severe neutropenia during treatment of multiple myeloma.
Topics: Adult; Aged; Bone Marrow; Female; Granulocyte Colony-Stimulating Factor; Humans; Male; Middle Aged; | 2004 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Efficacy of lenalidomide in myelodysplastic syndromes.
Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge | 2005 |
Lenalidomide therapy in myelofibrosis with myeloid metaplasia.
Topics: Administration, Oral; Adult; Aged; Anemia; Anemia, Myelophthisic; Female; Hemoglobins; Humans; Janus | 2006 |
The neutropenia induced by the thalidomide analogue CC-4047 in patients with multiple myeloma is associated with an increased percentage of neutrophils bearing CD64.
Topics: Adult; Aged; Apoptosis; Blood Platelets; Female; Humans; Immunologic Factors; Male; Middle Aged; Mul | 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 |
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 |
Lenalidomide-induced myelosuppression is associated with renal dysfunction: adverse events evaluation of treatment-naïve patients undergoing front-line lenalidomide and dexamethasone therapy.
Topics: Antineoplastic Combined Chemotherapy Protocols; Creatinine; Dexamethasone; Humans; Lenalidomide; Mul | 2007 |
Alternate day pomalidomide retains anti-myeloma effect with reduced adverse events and evidence of in vivo immunomodulation.
Topics: Adult; Aged; Antineoplastic Agents; Blood Cell Count; Dexamethasone; Dose-Response Relationship, Dru | 2008 |
Thalidomide as salvage therapy for chronic graft-versus-host disease.
Topics: Adolescent; Adult; Bone Marrow Transplantation; Child; Chronic Disease; Constipation; Cyclosporine; | 1995 |
Thalidomide for treatment of patients with chronic graft-versus-host disease.
Topics: Actuarial Analysis; Chronic Disease; Cyclosporine; Double-Blind Method; Drug Therapy, Combination; G | 2000 |
A randomized phase II trial of thalidomide, an angiogenesis inhibitor, in patients with androgen-independent prostate cancer.
Topics: Aged; Aged, 80 and over; Androgens; Angiogenesis Inhibitors; Dose-Response Relationship, Drug; Endot | 2001 |
27 other studies available for thalidomide and Neutropenia
Article | Year |
---|---|
Lenalidomide treatment of Japanese patients with myelodysplastic syndromes with 5q deletion: a post-marketing surveillance study.
Topics: Aged; Aged, 80 and over; Chromosome Aberrations; Chromosome Deletion; Chromosomes, Human, Pair 5; Ea | 2023 |
Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Türkiye
Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; Humans; Lenalidomide; Male; M | 2023 |
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 prospective multi-center trial of non-interventional and observational study of lenalidomide in Chinese patients with multiple myeloma].
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Chromosome Aberrations; Dexamethasone; Disease | 2017 |
Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum.
Topics: Adult; Aged; Aged, 80 and over; Dexamethasone; Drug Administration Schedule; Drug Therapy, Combinati | 2018 |
Pharmacokinetics and Exposure-Response Analyses of Daratumumab in Combination Therapy Regimens for Patients with Multiple Myeloma.
Topics: Age Factors; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy P | 2018 |
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 |
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 |
Report of 6 cases of large granular lymphocytic leukemia and plasma cell dyscrasia.
Topics: Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Proto | 2014 |
Polymorphisms within beta-catenin encoding gene affect multiple myeloma development and treatment.
Topics: Adaptor Proteins, Signal Transducing; Adult; Aged; Aged, 80 and over; Alleles; Antineoplastic Combin | 2015 |
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 |
An international, multicenter, prospective, observational study of neutropenia in patients being treated with lenalidomide + dexamethasone for relapsed or relapsed/refractory multiple myeloma (RR-MM).
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Femal | 2016 |
Pharmacovigilance of patients with multiple myeloma being treated with bortezomib and/or thalidomide.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocol | 2016 |
Risk factors for neutropenia with lenalidomide plus dexamethasone therapy for multiple myeloma.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Antineoplastic Comb | 2016 |
Thalidomide for steroid-dependent chronic disseminated candidiasis after stem cell transplantation: A case report.
Topics: Antifungal Agents; Bone Marrow Transplantation; Candida albicans; Candidiasis; Chronic Disease; Fluc | 2017 |
Lenalidomide for the treatment of resistant discoid lupus erythematosus.
Topics: Adult; Female; Humans; Lenalidomide; Lupus Erythematosus, Discoid; Neutropenia; Thalidomide | 2009 |
Immunomodulatory derivatives induce PU.1 down-regulation, myeloid maturation arrest, and neutropenia.
Topics: Antineoplastic Agents; Cell Differentiation; Cells, Cultured; Down-Regulation; Granulocyte Colony-St | 2010 |
Immunomodulatory derivatives induce PU.1 down-regulation, myeloid maturation arrest, and neutropenia.
Topics: Antineoplastic Agents; Cell Differentiation; Cells, Cultured; Down-Regulation; Granulocyte Colony-St | 2010 |
Immunomodulatory derivatives induce PU.1 down-regulation, myeloid maturation arrest, and neutropenia.
Topics: Antineoplastic Agents; Cell Differentiation; Cells, Cultured; Down-Regulation; Granulocyte Colony-St | 2010 |
Immunomodulatory derivatives induce PU.1 down-regulation, myeloid maturation arrest, and neutropenia.
Topics: Antineoplastic Agents; Cell Differentiation; Cells, Cultured; Down-Regulation; Granulocyte Colony-St | 2010 |
Management of myelodysplastic syndromes in the geriatric patient.
Topics: Aged; Anemia; Antineoplastic Agents; Azacitidine; Decitabine; Erythrocyte Transfusion; Erythropoieti | 2009 |
Treatment by Lenalidomide in lower risk myelodysplastic syndrome with 5q deletion--the GFM experience.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Chromosome Deletion; Chromosomes, Human, Pair | 2011 |
Prognostic risk factor evaluation in patients with relapsed or refractory multiple myeloma receiving lenalidomide treatment: analysis of renal function by eGFR and of additional comorbidities by comorbidity appraisal.
Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Comorbidity; Dep | 2012 |
Treatment for recurrent medulloblastoma with intrathecal liposomal cytarabine and systemic metronomic combination therapy.
Topics: Administration, Metronomic; Adolescent; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2012 |
Drug interaction between lenalidomide and itraconazole.
Topics: Antibiotic Prophylaxis; Antineoplastic Combined Chemotherapy Protocols; Area Under Curve; ATP Bindin | 2012 |
Lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone for heavily pretreated relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Dexa | 2013 |
Thalidomide-associated thrombocytopenia.
Topics: Administration, Oral; Aged; Dexamethasone; Female; Humans; Melphalan; Multiple Myeloma; Neutropenia; | 2005 |
Should prophylactic granulocyte-colony stimulating factor be used in multiple myeloma patients developing neutropenia under lenalidomide-based therapy?
Topics: Aged; Antineoplastic Agents; Clinical Trials as Topic; Dexamethasone; Drug Administration Schedule; | 2008 |
Pharmacologic inhibitors of tumor necrosis factor production exert differential effects in lethal endotoxemia and in infection with live microorganisms in mice.
Topics: Animals; Candidiasis; Chlorpromazine; Female; Interleukin-1; Kidney; Klebsiella Infections; Klebsiel | 1995 |
Safety and efficacy of thalidomide in patients with myelofibrosis with myeloid metaplasia.
Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Fatigue; Feasibility Studies; Female; Follo | 2001 |