Page last updated: 2024-11-05

thalidomide and Neutropenia

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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.

Research Excerpts

ExcerptRelevanceReference
"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."9.41Daratumumab 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)."9.41EMA 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)."9.27Elotuzumab 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)."9.24Lenalidomide 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)."9.24Continuous 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])."9.22Lenalidomide 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)."9.19Pomalidomide 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."9.19Bortezomib-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."9.17Phase 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."9.17Phase 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."9.16Efficacy, 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)."9.16Phase 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."9.16Continuous 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)."9.15Lenalidomide, 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."9.14Melphalan, 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."9.14Phase 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."9.12The 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."9.11Thalidomide-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."9.11Efficacy 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)."9.09Thalidomide 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)."9.08Thalidomide 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)."8.90Expert 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."8.87Management 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)."8.84Lenalidomide: 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."8.31Lenalidomide 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."7.88Pomalidomide 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."7.83An 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."7.83Pharmacovigilance 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."7.83Risk 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)."7.81Intermittent 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)."7.79Lenalidomide (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)."7.74Should 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)."7.73Thalidomide-associated thrombocytopenia. ( Brouwers, JR; Duyvendak, M; Kingma, BJ; Naunton, M, 2005)
" Continous high dosing schedules are poorly tolerated and minimally active."6.84A 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."6.84Lenalidomide 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."6.80Lenalidomide 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)."6.79A 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."6.75Single 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."6.55Lenalidomide 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."5.41Daratumumab 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)."5.41EMA 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."5.38Prognostic 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."5.38Treatment 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)."5.27Elotuzumab 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)."5.24Lenalidomide 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)."5.24Continuous 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])."5.22Lenalidomide 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."5.22VTD 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)."5.19Pomalidomide 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."5.19Bortezomib-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."5.19Autologous 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."5.17Phase 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."5.17Phase 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."5.16Efficacy, 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)."5.16Phase 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."5.16Continuous 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)."5.15Lenalidomide, 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."5.14Lenalidomide 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."5.14Melphalan, 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)."5.14A 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."5.14Phase 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."5.12The 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."5.12Lenalidomide-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."5.11Thalidomide-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."5.11Efficacy 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."5.10Immunomodulatory 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)."5.09Thalidomide 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)."5.08Thalidomide 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."4.93Maintenance 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)."4.90Expert 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."4.87Management 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)."4.84Lenalidomide: 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."4.83Immunomodulatory 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."4.31Lenalidomide 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."3.88Pomalidomide 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."3.83Lenalidomide 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."3.83An 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."3.83Pharmacovigilance 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."3.83Risk 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)."3.81Intermittent 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."3.80Efficacy 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)."3.79Lenalidomide (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."3.76Immunomodulatory 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)."3.74Should 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)."3.73Thalidomide-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)."2.87Rituximab 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)."2.84Long-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."2.84A 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."2.84Lenalidomide 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."2.82Results 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."2.80A 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)."2.80A 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."2.80Lenalidomide 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)."2.79A 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."2.77Final 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."2.77Efficacy 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."2.76A 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."2.75Single 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."2.74Lenalidomide 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."2.74Lenalidomide 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."2.74Lenalidomide 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."2.73Alternate 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."2.72Clinical 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."2.70A 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."2.55Lenalidomide 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."1.48Pharmacokinetics 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."1.38Prognostic 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."1.38Treatment 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."1.35Lenalidomide for the treatment of resistant discoid lupus erythematosus. ( Albrecht, J; Bonilla-Martinez, Z; Okawa, J; Rose, M; Rosenbach, M; Shah, A; Werth, VP, 2009)

Research

Studies (96)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's2 (2.08)18.2507
2000's26 (27.08)29.6817
2010's61 (63.54)24.3611
2020's7 (7.29)2.80

Authors

AuthorsStudies
Wang, Y3
Zhang, M1
Song, W1
Cai, Q1
Zhang, L3
Sun, X1
Zou, L1
Zhang, H1
Wang, L1
Xue, H1
Uno, S1
Motegi, Y1
Minehata, K1
Aoki, Y1
Xia, Z1
Leng, Y1
Fang, B1
Liang, Y1
Li, W1
Fu, C1
Yang, L1
Ke, X2
Jiang, H1
Weng, J1
Liu, L1
Zhao, Y2
Zhang, X3
Huang, Z2
Liu, A1
Shi, Q1
Gao, Y1
Chen, X1
Pan, L1
Cai, Z1
Wang, Z2
Fan, Y1
Hou, M1
Ma, Y2
Hu, J1
Liu, J1
Zhou, J1
Meng, H1
Lu, X1
Li, F1
Ren, H1
Huang, B1
Shao, Z1
Zhou, H1
Hu, Y2
Yang, S2
Zheng, X2
Wei, P2
Pang, H1
Yu, W1
Liu, Y2
Gao, S1
Yan, L1
Jing, H1
Du, J1
Ling, W1
Zhang, J2
Sui, W1
Wang, F2
Li, X1
Chen, W1
Tekinalp, A1
Gedük, A1
Akdeniz, A1
Terzi Demirsoy, E1
Gürsoy, V1
Aslaner Ak, M1
Bağcı, M1
Seçilmiş, S1
Keklik Karadağ, F1
Oruç Uysal, A1
Doğan, A1
Demircioğlu, S1
Erol, HA1
Aslan, C1
Özkalemkaş, F1
Ertop, Ş1
Dağlı, M1
Dal, MS1
Saydam, G1
Merter, M1
Ural, C1
Çeneli, Ö1
Zhou, X1
Steinhardt, MJ1
Grathwohl, D1
Meckel, K1
Nickel, K1
Leicht, HB1
Krummenast, F1
Einsele, H2
Rasche, L1
Kortüm, KM1
Dimopoulos, MA7
Terpos, E3
Boccadoro, M5
Delimpasi, S1
Beksac, M2
Katodritou, E1
Moreau, P4
Baldini, L1
Symeonidis, A1
Bila, J1
Oriol, A1
Mateos, MV4
Orfanidis, I1
Ahmadi, T1
Ukropec, J1
Kampfenkel, T1
Schecter, JM1
Qiu, Y1
Amin, H1
Vermeulen, J1
Carson, R1
Sonneveld, P4
Delgado, J1
Zienowicz, M1
van Hennik, PB1
Moreau, A1
Gisselbrecht, C1
Enzmann, H1
Pignatti, F1
Thieblemont, C1
Tilly, H2
Gomes da Silva, M2
Casasnovas, RO2
Fruchart, C2
Morschhauser, F2
Haioun, C2
Lazarovici, J1
Grosicka, A1
Perrot, A1
Trotman, J1
Sebban, C1
Caballero, D1
Greil, R2
van Eygen, K1
Cohen, AM1
Gonzalez, H1
Bouabdallah, R3
Oberic, L1
Corront, B1
Choufi, B1
Lopez-Guillermo, A2
Catalano, J2
Van Hoof, A1
Briere, J1
Cabeçadas, J1
Salles, G2
Gaulard, P1
Bosly, A1
Coiffier, B1
Wang, GM1
Yang, GZ1
Huang, ZX1
Zhong, YP1
Jin, FY1
Liao, AJ1
Wang, XM1
Fu, ZZ1
Liu, H1
Li, XL1
Zhou, JF1
Meng, FY1
Huang, XJ1
Chen, WM3
Lu, J2
Witzig, TE3
Luigi Zinzani, P1
Habermann, TM2
Tuscano, JM2
Drach, J1
Ramchandren, R1
Kalayoglu Besisik, S1
Takeshita, K4
Casadebaig Bravo, ML1
Fu, T1
Goy, A1
Blair, HA1
Richardson, PG4
Holstein, SA1
Schlossman, RL2
Anderson, KC5
Attal, M2
McCarthy, PL1
Matsumura-Kimoto, Y1
Kuroda, J1
Kaneko, H1
Kamitsuji, Y1
Fuchida, SI1
Nakaya, A1
Shibayama, H1
Uoshima, N1
Yokota, I1
Uchiyama, H1
Yagi, H1
Kosugi, S1
Matsui, T1
Ishikawa, J1
Matsuda, M1
Ohta, K1
Iida, M1
Tanaka, H1
Kobayashi, M1
Wada, K1
Shimazaki, C1
Nomura, S1
Imada, K1
Hino, M1
Matsumura, I1
Kanakura, Y1
Takaori-Kondo, A1
Fowler, NH1
Feugier, P1
Palomba, ML1
Libby, EN1
Flinn, IW1
Maisonneuve, H1
Ysebaert, L1
Bartlett, NL1
Bouabdallah, K1
Brice, P2
Ribrag, V1
Daguindau, N1
Le Gouill, S1
Pica, GM1
Martin Garcia-Sancho, A1
Larouche, JF1
Ando, K1
André, M1
Zachée, P1
Sehn, LH1
Tobinai, K2
Cartron, G1
Liu, D1
Wang, J2
Xerri, L1
Salles, GA1
Xu, XS1
Ho, PJ1
Belch, A2
Leiba, M1
Capra, M1
Gomez, D1
Medvedova, E1
Iida, S1
Min, CK2
Schecter, J1
Jansson, R1
Sun, YN1
Clemens, PL1
Dytfeld, D1
Grosicki, S1
Takezako, N1
Hori, M1
Leleu, X4
LeBlanc, R2
Suzuki, K1
Raab, MS1
Popa McKiver, M1
Jou, YM1
Shelat, SG1
Robbins, M1
Rafferty, B1
San-Miguel, J2
Niesvizky, R3
Martin, TG1
Bensinger, WI1
Alsina, M2
Siegel, DS3
Kunkel, LA1
Wong, AF1
Lee, S1
Orlowski, RZ2
Wang, M2
Safran, H1
Charpentier, KP1
Kaubisch, A1
Mantripragada, K1
Dubel, G1
Perez, K1
Faricy-Anderson, K1
Miner, T1
Eng, Y1
Victor, J1
Plette, A1
Espat, J1
Bakalarski, P1
Wingate, P1
Berz, D1
Luppe, D1
Martel, D1
Rosati, K1
Aparo, S1
Martin, T1
Bensinger, W1
Kavalerchik, E1
Huang, M1
Vij, R2
Hofmeister, CC1
Baz, R2
Jagannath, S1
Chen, C3
Lonial, S2
Jakubowiak, A1
Bahlis, N1
Song, K1
Raje, N1
Shustik, C1
Lentzsch, S2
Lacy, M1
Mikhael, J1
Matous, J2
Vesole, D1
Chen, M1
Zaki, MH1
Jacques, C2
Yu, Z2
Palumbo, A6
Bringhen, S1
Larocca, A2
Rossi, D1
Di Raimondo, F2
Magarotto, V2
Patriarca, F2
Levi, A1
Benevolo, G2
Vincelli, ID1
Grasso, M1
Franceschini, L1
Gottardi, D1
Zambello, R2
Montefusco, V1
Falcone, AP1
Omedé, P2
Marasca, R1
Morabito, F2
Mina, R1
Guglielmelli, T1
Nozzoli, C1
Passera, R1
Gaidano, G1
Offidani, M3
Ria, R1
Petrucci, MT4
Musto, P4
Cavo, M4
Delforge, M2
Ludwig, H1
Morgan, GJ1
Davies, FE1
Schey, SA3
Zweegman, S2
Hansson, M1
Weisel, K2
Facon, T3
Miguel, JF1
Ivanov, V1
Coso, D1
Chetaille, B1
Esterni, B1
Olive, D1
Aurran-Schleinitz, T1
Schiano, JM1
Stoppa, AM2
Broussais-Guillaumot, F1
Blaise, D1
Sun, HL1
Atenafu, EG1
Yeboah, E1
Reece, DE2
Trudel, S2
Kukreti, V2
Masih-Khan, E1
Winter, A1
Cheng, J1
Talamo, G1
Malysz, J1
Ochmann, M1
Lamy, T2
Loughran, TP1
Huang, H1
Zhou, L1
Peng, L1
Fu, W1
Zhang, C1
Hou, J2
Geng, C1
Qiu, L2
Xi, H1
Wei, N1
Zhu, B1
Costa, LJ1
Fanning, SR1
Stephenson, J1
Afrin, LB1
Kistner-Griffin, E1
Bentz, TA1
Stuart, RK1
Cavallo, F2
Gay, F2
Ben Yehuda, D2
Pezzatti, S1
Caravita, T1
Cerrato, C1
Ribakovsky, E1
Genuardi, M1
Cafro, A1
Marcatti, M1
Catalano, L1
Carella, AM1
Zamagni, E1
Evangelista, A1
Ciccone, G1
Crippa, C1
Corradini, P1
Nagler, A1
Roziaková, L1
Mistrík, M1
Bátorová, A1
Cheson, BD1
Crawford, J1
Ullenhag, GJ1
Rossmann, E1
Liljefors, M1
Fouquet, G1
Guidez, S1
Petillon, MO1
Louni, C1
Ohyba, B1
Dib, M2
Poulain, S1
Herbaux, C1
Martin, A1
Thielemans, B1
Choquet, S1
Bakala, J1
Bories, C1
Demarquette, H1
Nudel, M1
Tournilhac, O1
Arnulf, B1
LeGouill, S1
Morel, P1
Banos, A2
Karlin, L1
Leblond, V1
Butrym, A1
Rybka, J1
Łacina, P1
Gębura, K1
Frontkiewicz, D1
Bogunia-Kubik, K1
Mazur, G1
Ruan, J1
Martin, P1
Shah, B1
Schuster, SJ1
Smith, SM1
Furman, RR2
Christos, P1
Rodriguez, A1
Svoboda, J1
Lewis, J1
Katz, O1
Coleman, M2
Leonard, JP2
Yang, F1
Shen, Y1
Zhang, W1
Chang, VT1
Andersson, BS1
Qazilbash, MH1
Champlin, RE1
Berenson, JR1
Guan, X1
Wang, ML1
Zagouri, F1
Roussou, M1
Kastritis, E1
Gavriatopoulou, M1
Eleutherakis-Papaiakovou, E1
Kanellias, N1
Kalapanida, D1
Christoulas, D1
Migkou, M1
Ogura, M1
Imaizumi, Y1
Uike, N1
Asou, N1
Utsunomiya, A1
Uchida, T1
Aoki, T1
Tsukasaki, K1
Taguchi, J1
Choi, I1
Maruyama, D1
Nosaka, K1
Chen, N1
Midorikawa, S1
Ohtsu, T1
Hulin, C2
Macro, M1
Caillot, D1
Chaleteix, C1
Roussel, M1
Garderet, L1
Royer, B1
Brechignac, S1
Tiab, M1
Puyade, M1
Escoffre, M1
Pegourie, B1
Chaoui, D1
Jaccard, A1
Slama, B1
Marit, G1
Laribi, K1
Godmer, P1
Luycx, O1
Eisenmann, JC1
Allangba, O1
Araujo, C1
Fontan, J1
Belhadj, K1
Wetterwald, M1
Dorvaux, V1
Fermand, JP1
Rodon, P1
Kolb, B1
Glaisner, S1
Malfuson, JV1
Lenain, P1
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Caillon, H1
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Williams, C1
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Pietronigro, D2
Zeldis, JB6
Shah, A1
Albrecht, J1
Bonilla-Martinez, Z1
Okawa, J1
Rose, M1
Rosenbach, M1
Werth, VP1
Kay, NE1
Shanafelt, TD1
Call, TG1
Wu, W1
Laplant, BR1
Falco, P1
Falcone, A1
Canepa, L1
Gozzetti, A1
Luraschi, A1
Nozza, A1
Knight, RD1
Quintás-Cardama, A1
Kantarjian, HM2
Manshouri, T1
Thomas, D2
Cortes, J2
Ravandi, F1
Garcia-Manero, G1
Ferrajoli, A2
Bueso-Ramos, C1
Verstovsek, S2
Moore, T1
Reeder, C1
Cole, C1
Kaplan, H1
Voralia, M1
Pal, R1
Monaghan, SA1
Hassett, AC1
Mapara, MY1
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van Marwijk Kooy, M1
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González Rodríguez, AP1
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Kumar, SK1
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Laumann, K1
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Gertz, MA1
Zeldenrust, SR1
Bergsagel, PL1
Reeder, CB1
Fonseca, R1
Russell, SJ1
Mikhael, JR1
Dingli, D1
Rajkumar, SV1
Dispenzieri, A1
Le Bras, F1
Sebert, M1
Kelaidi, C1
Dreyfus, F1
Delaunay, J1
Blanc, M1
Vey, N1
Schmidt, A1
Visanica, S1
Eclache, V1
Turlure, P1
Beyne-Rauzy, O1
Guerci, A1
Delmer, A1
de Botton, S1
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Wendtner, CM1
Hillmen, P1
Mahadevan, D2
Bühler, A1
Uharek, L1
Coutré, S1
Frankfurt, O1
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Dreisbach, L1
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Shah, S1
Moutouh-de Parseval, L1
Hallek, M1
Heerema, NA1
Stilgenbauer, S1
Komrokji, RS1
Kleber, M1
Ihorst, G1
Udi, J1
Koch, B1
Wäsch, R1
Engelhardt, M1
Nygaard, R1
Kivivuori, SM1
Takahashi, N1
Miura, M1
Kameoka, Y1
Abumiya, M1
Sawada, K1
Wolf, JL1
Siegel, D1
Goldschmidt, H1
Hazell, K1
Bourquelot, PM1
Bengoudifa, BR1
de Magalhaes-Silverman, M1
Abonour, R1
Alegre, A1
Oriol-Rocafiguera, A1
Garcia-Larana, J1
Sureda, A1
Martinez-Chamorro, C1
Cibeira, MT1
Aguado, B1
Rosettani, B1
Polloni, C1
Liberati, AM1
Ballanti, S1
Pulini, S1
Catarini, M1
Alesiani, F1
Corvatta, L1
Gentili, S1
Caraffa, P1
Leoni, P1
Hajek, R1
Kropff, M1
Gisslinger, H1
Wiktor-Jędrzejczak, W1
Zodelava, M1
Cascavilla, N1
Iosava, G1
Kloczko, J1
Bladé, J1
Spicka, I1
Plesner, T1
Radke, J1
Langer, C1
Corso, A1
Herbein, L1
Mei, J1
Jimenez-Zepeda, VH1
Tiedemann, R1
Cortés-Hernández, J1
Ávila, G1
Vilardell-Tarrés, M1
Ordi-Ros, J1
Weller, E1
Hideshima, T1
Mitsiades, C1
Davies, F1
Catley, LP1
Doss, D1
Kelly, K1
McKenney, M1
Mechlowicz, J1
Freeman, A1
Deocampo, R1
Rich, R1
Ryoo, JJ1
Chauhan, D1
Balinski, K1
Zeldis, J1
Okikawa, Y1
Takimoto, Y1
Noda, M1
Imagawa, J1
Katayama, Y1
Sakai, A1
Okita, H1
Fujimura, K1
Kimura, A1
Hattori, Y1
Kakimoto, T1
Okamoto, S1
Sato, N1
Ikeda, Y1
Eleutherakis-Papaiakovou, V1
Kurtin, S1
Roe, DJ1
Buresh, A1
Fuchs, D1
Rimsza, L1
Heaton, R1
Duyvendak, M1
Naunton, M1
Kingma, BJ1
Brouwers, JR1
Tefferi, A1
Mesa, RA1
Lasho, TL1
Hogan, WJ1
Litzow, MR1
Allred, JB1
Jones, D1
Byrne, C2
Ketterling, RP1
McClure, RF1
Giles, F1
McCarthy, DA1
Macey, MG1
Streetly, M1
Brown, KA1
Galili, N1
Chanan-Khan, A1
Musial, L1
Lawrence, D1
Padmanabhan, S1
Porter, CW1
Goodrich, DW1
Bernstein, ZP1
Wallace, P1
Spaner, D1
Mohr, A1
Hernandez-Ilizaliturri, F1
Chrystal, C1
Starostik, P1
Czuczman, MS1
Naib, T1
Christos, PJ1
Jayabalan, D1
Furst, JR1
Jalbrzikowski, J1
Zafar, F1
Mark, T1
Lent, R1
Pearse, RN1
Ely, S1
Mazumdar, M1
Chen-Kiang, S1
Tariman, JD1
García-Sanz, R1
Colado, E1
Olazábal, J1
Streetly, MJ1
Gyertson, K1
Daniel, Y1
Kazmi, M1
Parker, PM1
Chao, N1
Nademanee, A1
O'Donnell, MR1
Schmidt, GM1
Snyder, DS1
Stein, AS1
Smith, EP1
Molina, A1
Stepan, DE1
Kashyap, A1
Planas, I1
Spielberger, R1
Somlo, G1
Margolin, K1
Zwingenberger, K1
Wilsman, K1
Negrin, RS1
Long, GD1
Niland, JC1
Blume, KG1
Forman, SJ1
Netea, MG1
Blok, WL1
Kullberg, BJ1
Bemelmans, M1
Vogels, MT1
Buurman, WA1
van der Meer, JW1
Koc, S1
Leisenring, W1
Flowers, ME1
Anasetti, C1
Deeg, HJ1
Nash, RA1
Sanders, JE1
Witherspoon, RP1
Appelbaum, FR1
Storb, R1
Martin, PJ1
Figg, WD1
Dahut, W1
Duray, P1
Hamilton, M1
Tompkins, A1
Steinberg, SM1
Jones, E1
Premkumar, A1
Linehan, WM1
Floeter, MK1
Chen, CC1
Dixon, S1
Kohler, DR1
Krüger, EA1
Gubish, E1
Pluda, JM1
Reed, E1
Barosi, G1
Grossi, A1
Comotti, B1
Gamba, G1
Marchetti, M1

Clinical Trials (59)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial[NCT03273452]Phase 230 participants (Anticipated)Interventional2017-03-01Recruiting
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 3304 participants (Actual)Interventional2017-06-12Active, not recruiting
A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China[NCT01947309]176 participants (Actual)Observational2013-11-30Terminated (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 2134 participants (Actual)Interventional2008-12-22Completed
Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response[NCT04508647]Phase 24 participants (Actual)Interventional2020-11-23Completed
"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 31,030 participants (Actual)Interventional2012-02-29Active, 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 3358 participants (Actual)Interventional2013-11-21Completed
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 3255 participants (Actual)Interventional2011-12-29Active, 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 2117 participants (Actual)Interventional2016-03-18Completed
Phase 1b Multicenter Dose Escalation Study of Carfilzomib With Lenalidomide and Dexamethasone for Safety and Activity in Relapsed Multiple Myeloma[NCT00603447]Phase 184 participants (Actual)Interventional2008-05-31Completed
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 223 participants (Anticipated)Interventional2023-06-05Not yet recruiting
Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial[NCT00717756]Phase 241 participants (Actual)Interventional2009-01-31Completed
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 266 participants (Anticipated)Interventional2022-05-13Recruiting
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 2259 participants (Actual)Interventional2008-06-30Completed
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 29 participants (Actual)Interventional2016-01-31Terminated
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 3511 participants (Actual)Interventional2006-05-31Completed
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)Observational2021-11-30Recruiting
Multicenter Study of Pomalidomide, Cyclophosphamide, and Dexamethasone in Relapsed Refractory Myeloma: Safety Profile in Mexican Population[NCT03601624]Phase 218 participants (Anticipated)Interventional2018-09-01Recruiting
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 3402 participants (Actual)Interventional2007-06-30Active, 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 234 participants (Actual)Interventional2009-10-31Completed
A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia[NCT02302469]Phase 1/Phase 217 participants (Actual)Interventional2009-03-31Completed
Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma[NCT01472562]Phase 238 participants (Actual)Interventional2011-07-29Completed
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 113 participants (Actual)Interventional2010-07-01Completed
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 3722 participants (Actual)Interventional2012-08-01Completed
Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD)[NCT00867308]Phase 232 participants (Actual)Interventional2009-07-31Terminated (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 31,623 participants (Actual)Interventional2008-08-21Completed
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 13 participants (Actual)Interventional2019-01-12Terminated (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 247 participants (Anticipated)Interventional2009-10-31Recruiting
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 2148 participants (Actual)Interventional2003-06-01Completed
Phase II Clinical Study of Zanubrutinib Combined With Bendamustine and Rituximab (ZBR) for Time-limited Treatment of Waldenstrom Macroglobulinemia[NCT05914662]Phase 230 participants (Anticipated)Interventional2023-02-15Recruiting
Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia[NCT00142168]Phase 216 participants (Actual)Interventional2004-09-30Terminated (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 127 participants (Actual)Interventional2015-06-18Active, not recruiting
Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)[NCT00352794]Phase 240 participants (Actual)Interventional2006-07-07Completed
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 243 participants (Actual)Interventional2005-08-31Completed
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 226 participants (Actual)Interventional2017-06-14Active, not recruiting
Thrombosis in Newly Diagnosed Multiple Myeloma Patients: a Clinical Audit of Intermediate Dose Low Molecular Weight Heparin[NCT05541978]140 participants (Actual)Observational2022-09-01Completed
A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow[NCT03992170]Phase 250 participants (Anticipated)Interventional2018-12-31Recruiting
[NCT01036399]Phase 29 participants (Actual)Interventional2008-11-30Terminated (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 260 participants Interventional2005-04-30Completed
A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma[NCT00478218]Phase 253 participants (Actual)Interventional2006-07-31Completed
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 152 participants (Actual)Interventional2006-12-01Completed
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma[NCT00420849]Phase 3587 participants (Actual)Interventional2006-11-30Completed
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 3459 participants (Actual)Interventional2007-01-31Completed
Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus[NCT01408199]Phase 415 participants (Actual)Interventional2010-01-31Completed
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 221 participants (Actual)Interventional2012-02-22Completed
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 254 participants Interventional2005-01-31Completed
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 212 participants (Actual)Interventional2016-12-12Terminated (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 3120 participants (Actual)Interventional2007-05-31Completed
Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma[NCT01042704]Phase 129 participants (Actual)Interventional2008-02-29Completed
A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma[NCT04009109]Phase 2188 participants (Anticipated)Interventional2020-10-21Recruiting
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 361 participants (Actual)Interventional2010-01-31Completed
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome[NCT00044382]Phase 225 participants Interventional2002-02-01Completed
Salvage in Patients With Myelodysplastic Syndrome After Failure of Hypomethylating Agents: Lenalidomide as a Second-line Therapy[NCT01673308]Phase 235 participants (Anticipated)Interventional2012-08-31Active, 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 260 participants (Anticipated)Interventional2010-02-28Recruiting
Phase II Trial of Lenalidomide in Older Patients (>/= 60 Years) With Untreated Acute Myeloid Leukemia Without Chromosome 5q Abnormalities[NCT00546897]Phase 248 participants (Actual)Interventional2007-02-28Completed
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 280 participants (Anticipated)Interventional2008-02-29Recruiting
Phase 2 Trial of Lenalidomide (Revlimid)-Dexamethasone + Rituximab in Recurrent Small B-Cell Non-Hodgkin Lymphomas (NHL) Resistant to Rituximab[NCT00783367]Phase 250 participants (Actual)Interventional2008-07-31Completed
A Phase I/II Study of Combination Dasatinib and Lenalidomide in Purine Analogue-Failed Chronic Lymphocytic Leukemia[NCT00829647]Phase 1/Phase 20 participants (Actual)Interventional2009-01-31Withdrawn (stopped due to Unable to enroll)
Evaluation of TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect[NCT00121563]Phase 290 participants Interventional2005-07-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Comparison of Progression Free Survival Between Treatment Arms

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)]

Interventionmonths (Median)
Daratumumab+Pomalidomide+Dexamethasone12.42
Pomalidomide + Dexamethasone6.93

Depth of Response

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.

Interventionpercentage of participants (Number)
Daratumumab+Pomalidomide+Dexamethasone8.61
Pomalidomide + Dexamethasone1.96

Duration of Response

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.

Interventionmonths (Median)
Daratumumab+Pomalidomide+DexamethasoneNA
Pomalidomide + Dexamethasone15.90

Health-related Quality of Life-Time to Worsening in EORTC QLQ-C30 Scale Scores

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)

Interventionmonths (Median)
Daratumumab+Pomalidomide+Dexamethasone4.01
Pomalidomide + Dexamethasone3.84

Health-related Quality of Life-Time to Worsening in EQ-5D-5L Utility Score

"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)

Interventionmonths (Mean)
Daratumumab+Pomalidomide+Dexamethasone7.39
Pomalidomide + Dexamethasone6.14

Health-related Quality of Life-Time to Worsening in EQ-5D-5L Visual Analogue Scale

"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)

Interventionmonths (Mean)
Daratumumab+Pomalidomide+Dexamethasone3.78
Pomalidomide + Dexamethasone2.86

Overall Response Rate

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)]

Interventionpercentage of participants (Number)
Daratumumab+Pomalidomide+Dexamethasone68.87
Pomalidomide + Dexamethasone46.41

Time to Next Therapy

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)

Interventionmonths (Median)
Daratumumab+Pomalidomide+Dexamethasone23.23
Pomalidomide + Dexamethasone11.83

Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee

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

Interventionmonths (Median)
Lenalidomide24.43

Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee

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.

Interventionmonths (Median)
Lenalidomide16.64

Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee

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

Interventionmonths (Median)
Lenalidomide5.46

Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee

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

Interventionmonths (Median)
Lenalidomide4.01

Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee

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

Interventionmonths (Median)
Lenalidomide3.75

Overall Survival (OS)

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

Interventionmonths (Median)
Lenalidomide19.50

Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)

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.

Interventionpercentage of participants (Number)
Lenalidomide29.9

Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee

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

Interventionpercentage of participants (Number)
Lenalidomide9.0

Time to Complete Response (CR+CRu) According to the Independent Review Committee

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

Interventionmonths (Median)
Lenalidomide3.9

Time to Response (TTR)

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

Interventionmonths (Median)
Lenalidomide3.5

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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)

Interventionparticipants (Number)
Any TEAEAny TEAE Related to Investigational Product (IP)Any TEAE Grade 3-5 AEAny TEAE Grade 3 AEAny TEAE Grade 4 AEAny TEAE Grade 5 AEAny Grade 3-5 AE Related to IPAny Grade 3 AE Related to IPAny Grade 4 AE Related to IPAny Grade 5 AE Related to IPAny TEAE Serious Adverse Event (SAE)Any SAE Related to IPAny TEAE Leading to Stopping of IPAny Treatment Related AE Leading to Stopping IPAny AE Leading to Dose ReductionAny AE Leading to IP InterruptionAny Treatment Related AE Leading to Dose ReductionTreatment Related AE Leading to IP Interruption
Lenalidomide132118106101571890884127030281655815266

Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent Induction

"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

InterventionParticipants (Count of Participants)
Ublituximab Only2

Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib.

"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

InterventionParticipants (Count of Participants)
Ublituximab Only2
Ublituximab First, Then Ublituximab and Umbralisib2

Overall Response Rates (ORR) for Number of Participants

"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

InterventionParticipants (Count of Participants)
Ublituximab Only2
Ublituximab First, Then Ublituximab and Umbralisib2

Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC

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

InterventionPercentage of Participants (Number)
Rituximab + Lenalidomide (R^2)25.3
Rituximab + Placebo11.1

Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC

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).

Interventionmonths (Median)
Rituximab + Lenalidomide (R^2)27.6
Rituximab + Placebo13.9

Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)

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).

Interventionmonths (Median)
Rituximab + Lenalidomide (R^2)39.4
Rituximab + Placebo14.1

Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)

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)

InterventionMonths (Median)
Rituximab + Lenalidomide (R^2)73.1
Rituximab + Placebo31.8

Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC

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).

Interventionmonths (Median)
Rituximab + Lenalidomide (R^2)NA
Rituximab + PlaceboNA

Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC

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).

Interventionmonths (Median)
Rituximab + Lenalidomide (R^2)36.6
Rituximab + Placebo21.7

Kaplan-Meier Estimate of Overall Survival (OS)

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)

InterventionMonths (Median)
Rituximab + Lenalidomide (R^2)NA
Rituximab + PlaceboNA

Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC

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

InterventionPercentage of Participants (Number)
Rituximab + Lenalidomide (R^2)33.7
Rituximab + Placebo18.3

Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC

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

InterventionPercentage of Participants (Number)
Rituximab + Lenalidomide (R^2)77.5
Rituximab + Placebo53.3

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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)

,
InterventionParticipants (Count of Participants)
Any TEAEAny TEAE Related to Lenalidomide/Placebo (LEN/PBO)Any TEAE Related to Rituximab (RIT)Any Serious TEAEAny Serious TEAE Related to LEN/PBOAny Serious TEAE Related to RITAny CTCAE Grade (GR) 3/4 TEAEAny CTCAE GR 3/4 TEAE Related to LEN/PBOAny CTCAE GR 3/4 TEAE Related to RITAny GR 5 TEAEAny TEAE Leading to Dose Reduction LEN/PBOAny TEAE Leading to Dose Interruption LEN/PBOAny TEAE Leading to Dose Interruption RITAny TEAE Leading to Discontinuation of LEN/PBOAny TEAE Leading to Discontinuation of RIT
Rituximab + Lenalidomide (R^2)1741591344523131211015724611359156
Rituximab + Placebo173118105258458382026473892

Objective Response Rate (ORR)

"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)

InterventionPercent of participants (Number)
E-Pd Cohort58.3
Pd Cohort24.6

Overall Survival (OS)

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)

InterventionMonths (Median)
E-Pd Cohort29.80
Pd Cohort17.41

Progression Free Survival (PFS)

"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)

InterventionMonths (Median)
E-Pd Cohort10.25
Pd Cohort4.70

Number of Participants With Dose-limiting Toxicities

"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

Interventionparticipants (Number)
1: CFZ 15 mg/m² + LEN 10 mg0
2: CFZ 15 mg/m² + LEN 15 mg0
3: CFZ 15 mg/m² + LEN 20 mg0
4: CFZ 20 mg/m² + LEN 20 mg0
5: CFZ 20 mg/m² + LEN 25 mg0
6: CFZ 20/27 mg/m² + LEN 25 mg1

Number of Participants With Adverse Events (AEs)

"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.

,,,,,,
Interventionparticipants (Number)
Any adverse eventTreatment-related adverse eventGrade 3 or higher adverse eventTreatment-related Grade 3 or higher adverse eventSerious adverse eventAE leading to discontinuation of any study drugAE leading to discontinuation of carfilzomibDeaths within 30 days of last dose of study drug
1: CFZ 15 mg/m² + LEN 10 mg64513100
2: CFZ 15 mg/m² + LEN 15 mg65643100
3: CFZ 15 mg/m² + LEN 20 mg88874310
4: CFZ 20 mg/m² + LEN 20 mg64644420
5: CFZ 20 mg/m² + LEN 25 mg66663210
6: CFZ 20/27 mg/m² + LEN 25 mg88886310
7: CFZ 20/27 mg/m² + LEN 25 mg44434138221893

Response Rate by Recist Criteria

"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.

Interventionparticipants (Number)
Lenalidomide6

Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1

"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event" (NCT00833833)
Timeframe: Up to Day 28 (Cycle 1)

Interventionparticipants (Number)
Phase 1: 2 mg Pomalidomide1
Phase 1: 3 mg Pomalidomide1
Phase 1: 4 mg Pomalidomide2
Phase 1: 5 mg Pomalidomide4

Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off

"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

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone32.1
Phase 2: PomalidomideNA

Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off

"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

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone62.6
Phase 2: Pomalidomide59.3

Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off

"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

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone16.6
Phase 2: Pomalidomide10.7

Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off

"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

Interventionpercentage of participants (Number)
Phase 2: Pomalidomide + Dexamethasone76.1
Phase 2: Pomalidomide75.0

Phase 2: Time to Response as of the 01 April 2011 Cut-off

"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

Interventionweeks (Median)
Phase 2: Pomalidomide + Dexamethasone8.1
Phase 2: Pomalidomide8.9

Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off

"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

,,,
Interventionpercentage of participants (Number)
1 or more (1+) AE1+ AE related to pomalidomide1+ AE related to dexamethasone1+ severity grade 3-4 AE1+ severity grade 3-4 AE related to pomalidomide1+ severity grade 3-4 AE related to dexamethasone1+ serious AE (SAE)1+ SAE related to pomalidomide1+ SAE related to dexamethasone1+ AE leading to discontinuation of pomalidomide1+ AE -- discontinuation of dexamethasone1+AE -dose reduction/interruption of pomalidomide1+ AE-dose reduction/interruption of dexamethasone1+related AE-reduction/interruption of pomalidomid1+related AE-reduction/interruption of dexamethaso
Phase 1: 2 mg Pomalidomide100.0100.0100.00.00.00.00.00.00.00.00.00.00.00.00.0
Phase 1: 3 mg Pomalidomide100.075.075.075.075.075.075.025.050.025.025.050.075.025.075.0
Phase 1: 4 mg Pomalidomide90.080.070.070.020.020.040.020.010.020.020.040.060.020.020.0
Phase 1: 5 mg Pomalidomide100.0100.085.757.142.90.028.60.00.00.00.071.471.457.142.9

Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off

"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

,,,
Interventionpercentage of participants (Number)
1 or more (1+) AE1+ AE related to pomalidomide1+ severity grade 3-4 AE1+ severity grade 3-4 AE related to pomalidomide1+ serious AE (SAE)1+ SAE related to pomalidomide1+ AE leading to discontinuation of pomalidomide1+AE-dose reduction/interruption of pomalidomide1+related AE-reduction/interruption of pomalidomid
Phase 1: 2 mg Pomalidomide100.066.783.333.350.00.016.716.70.0
Phase 1: 3 mg Pomalidomide100.075.037.525.012.512.50.075.037.5
Phase 1: 4 mg Pomalidomide100.085.778.642.942.97.121.442.928.6
Phase 1: 5 mg Pomalidomide100.0100.080.070.030.010.00.080.070.0

Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off

"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

,,,
Interventionpercentage of participants (Number)
1 or more (1+) AE1+ AE related to pomalidomide1+ severity grade 3-4 AE1+ severity grade 3-4 AE related to pomalidomide1+ serious AE (SAE)1+ SAE related to pomalidomide1+ AE leading to discontinuation of pomalidomide1+related AE --discontinuation of pomalidomide1+AE - reduction of pomalidomide1+ AE - interruption of pomalidomide1+ related AE - interruption of pomalidomide1+related AE - reduction of pomalidomide
Phase 2: Pomalidomide (Overall)100.088.889.767.367.320.612.13.729.958.932.724.3
Phase 2: Pomalidomide (Pom + Dex Only)93.468.970.544.347.519.73.31.69.836.121.38.2
Phase 2: Pomalidomide (Pom Only)99.187.984.158.946.79.310.32.825.247.724.320.6
Phase 2: Pomalidomide + Dexamethasone100.089.388.462.561.617.98.01.820.563.427.717.9

Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off

"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

,
Interventionpercentage of participants (Number)
Complete response (CR)Partial response (PR)Minimal response (MR)Stable disease (SD)Progressive disease (PD)Not evaluable
Phase 2: Pomalidomide0.09.315.746.315.713.0
Phase 2: Pomalidomide + Dexamethasone0.929.215.035.46.213.3

Number of Patients With Dose-limiting Toxicities and Treatment-emergent Adverse Events

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

InterventionParticipants (Count of Participants)
SL-401 7 µg/kg/Day7
SL-401 9 µg/kg/Day2

Number of Patients With Treatment-related Adverse Events

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

,
InterventionParticipants (Count of Participants)
At Least 1 Treatment-Related Treatment-Emergent Adverse EventFatigueNauseaPyrexiaHypoalbuminaemiaChillsInsomniaAspartate aminotransferase increasedConstipationDizzinessFlushingHeadacheHypophosphataemiaNeutropeniaOedema peripheralThrombocytopenia
SL-401 7 µg/kg/Day7554443223322332
SL-401 9 µg/kg/Day2112101110011001

Overall Response Rate

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

,
InterventionParticipants (Count of Participants)
Overall Response RateComplete ResponseStringent Complete ResponseVery Good Partial ResponsePartial ResponseMinimal ResponseStable DiseaseProgressive DiseaseProgressive Disease or Death After Overall ResponseCensored
SL-401 7 µg/kg/Day5000500014
SL-401 9 µg/kg/Day0000001000

Progression-free Survival

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

,
InterventionParticipants (Count of Participants)
Disease ProgressionDeathCensoredPFS at 6 MonthsPFS at 12 Months
SL-401 7 µg/kg/Day10441
SL-401 9 µg/kg/Day00100

Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug

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

,
InterventionParticipants (Count of Participants)
At Least 1 TEAE Leading to Discontinuation of Study DrugCapillary leak syndromeMetastatic malignant melanomaPancreatitisThrombocytopenia
SL-401 7 µg/kg/Day10100
SL-401 9 µg/kg/Day11011

Overall Response Rate

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

Interventionpercentage of patients (Number)
All Patients92

Duration of Response (DOR)

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

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone26.0
Placebo + Lenalidomide + Dexamethasone21.7

OS in High-Risk Participants

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)

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone46.9
Placebo + Lenalidomide + Dexamethasone30.9

Overall Response Rate (ORR) as Assessed by the IRC

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)

Interventionpercentage of participants (Number)
Ixazomib+ Lenalidomide + Dexamethasone78.3
Placebo + Lenalidomide + Dexamethasone71.5

Overall Response Rate in Participants Defined by Polymorphism

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)

Interventionpercentage of participants (Number)
Ixazomib+ Lenalidomide + Dexamethasone80.3
Placebo + Lenalidomide + Dexamethasone75.7

Overall Survival (OS)

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)

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone53.6
Placebo + Lenalidomide + Dexamethasone51.6

Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]

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)

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone42.2
Placebo + Lenalidomide + Dexamethasone29.4

Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC

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)

Interventionpercentage of participants (Number)
Ixazomib + Lenalidomide + Dexamethasone48.1
Placebo + Lenalidomide + Dexamethasone39.0

PFS in High-Risk Participants

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)

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone18.7
Placebo + Lenalidomide + Dexamethasone9.3

Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

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)

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone20.6
Placebo + Lenalidomide + Dexamethasone14.7

Time to Progression (TTP) as Assessed by the IRC

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)

Interventionmonths (Median)
Ixazomib+ Lenalidomide + Dexamethasone22.4
Placebo + Lenalidomide + Dexamethasone17.6

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)

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)

Interventionscore on a scale (Mean)
Global Health Index: BaselineGlobal Health Index: End of TreatmentPhysical Functioning: BaselinePhysical Functioning: EOTRole Functioning: BaselineRole Functioning: EOTEmotional Functioning: BaselineEmotional Functioning: EOTCognitive Functioning: BaselineCognitive Functioning: EOTSocial Functioning: BaselineSocial Functioning: EOTFatigue: BaselineFatigue: EOTPain: BaselinePain: EOTNausea and Vomiting: BaselineNausea and Vomiting: EOTDyspnea: BaselineDyspnea: EOTInsomnia: BaselineInsomnia: EOTAppetite Loss: BaselineAppetite Loss: EOTConstipation: BaselineConstipation: EOTDiarrhea: BaselineDiarrhea: EOTFinancial Difficulties: BaselineFinancial Difficulties: EOT
Ixazomib+ Lenalidomide + Dexamethasone58.4-6.070.0-4.768.4-8.675.1-2.181.9-7.677.9-6.938.46.038.02.75.03.421.25.727.40.916.94.712.2-1.36.317.216.70.5

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)

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)

Interventionscore on a scale (Mean)
Global Health Index: BaselineGlobal Health Index: End of TreatmentGlobal Health Index: Last Follow-upPhysical Functioning: BaselinePhysical Functioning: EOTPhysical Functioning: Last Follow-upRole Functioning: BaselineRole Functioning: EOTRole Functioning: Last Follow-upEmotional Functioning: BaselineEmotional Functioning: EOTEmotional Functioning: Last Follow-upCognitive Functioning: BaselineCognitive Functioning: EOTCognitive Functioning: Last Follow-upSocial Functioning: BaselineSocial Functioning: EOTSocial Functioning: Last Follow-upFatigue: BaselineFatigue: EOTFatigue: Last Follow-upPain: BaselinePain: EOTPain: Last Follow-upNausea and Vomiting: BaselineNausea and Vomiting: EOTNausea and Vomiting: Last Follow-upDyspnea: BaselineDyspnea: EOTDyspnea: Last Follow-upInsomnia: BaselineInsomnia: EOTInsomnia: Last Follow-upAppetite Loss: BaselineAppetite Loss: EOTAppetite Loss: Last Follow-upConstipation: BaselineConstipation: EOTConstipation: Last Follow-upDiarrhea: BaselineDiarrhea: EOTDiarrhea: Last Follow-upFinancial Difficulties: BaselineFinancial Difficulties: EOTFinancial Difficulties: Last Follow-up
Placebo + Lenalidomide + Dexamethasone56.4-6.016.767.3-6.20.064.4-8.6-16.775.3-6.1-25.081.6-5.8-50.075.3-7.90.039.56.722.238.53.80.06.00.633.323.72.30.030.5-0.533.315.36.50.013.52.233.38.110.80.018.61.3-33.3

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)

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)

Interventionscore on a scale (Mean)
Disease Symptoms: BaselineDisease Symptoms: EOTSide Effects of Treatment: BaselineSide Effects of Treatment: EOTSide Effects of Treatment: Last Follow-upBody Image: BaselineBody Image: EOTBody Image: Last Follow-upFuture Perspective: BaselineFuture Perspective: EOTFuture Perspective: Last Follow-up
Placebo + Lenalidomide + Dexamethasone30.41-2.5817.974.4337.0479.48-5.38-33.360.26-2.75-11.11

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)

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)

Interventionscore on a scale (Mean)
Disease Symptoms: BaselineDisease Symptoms: EOTDisease Symptoms: Last Follow-upSide Effects of Treatment: BaselineSide Effects of Treatment: EOTBody Image: BaselineBody Image: EOTFuture Perspective: BaselineFuture Perspective: EOT
Ixazomib+ Lenalidomide + Dexamethasone29.71-2.351.1117.234.5278.00-0.2756.992.76

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

,
InterventionParticipants (Count of Participants)
TEAEsSAEs
Ixazomib+ Lenalidomide + Dexamethasone359205
Placebo + Lenalidomide + Dexamethasone357201

Number of Participants With Change From Baseline in Pain Response

"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)

,
InterventionParticipants (Count of Participants)
BaselineEOT
Ixazomib+ Lenalidomide + Dexamethasone345145
Placebo + Lenalidomide + Dexamethasone351153

Plasma Concentration Over Time for Ixazomib

(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)

Interventionμg/mL (Mean)
Cycle 1 Day 1, 1 Hour Post-DoseCycle 1 Day 1, 4 Hours Post-DoseCycle 1 Day 14, Pre-DoseCycle 2 Day 1, Pre-DoseCycle 2 Day 14, Pre-DoseCycle 3 Day 1, Pre-DoseCycle 4 Day 1, Pre-DoseCycle 5 Day 1, Pre-DoseCycle 6 Day 1, Pre-DoseCycle 7 Day 1, Pre-DoseCycle 8 Day 1, Pre-DoseCycle 9 Day 1, Pre-DoseCycle 10 Day 1, Pre-Dose
Placebo + Lenalidomide + Dexamethasone0000000000000

Plasma Concentration Over Time for Ixazomib

(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)

Interventionμg/mL (Mean)
Cycle 1 Day 1Cycle 1 Day 1, 1 Hour Post-DoseCycle 1 Day 1, 4 Hours Post-DoseCycle 1 Day 14, Pre-DoseCycle 2 Day 1, Pre-DoseCycle 2 Day 14, Pre-DoseCycle 3 Day 1, Pre-DoseCycle 4 Day 1, Pre-DoseCycle 5 Day 1, Pre-DoseCycle 6 Day 1, Pre-DoseCycle 7 Day 1, Pre-DoseCycle 8 Day 1, Pre-DoseCycle 9 Day 1, Pre-DoseCycle 10 Day 1, Pre-Dose
Ixazomib+ Lenalidomide + Dexamethasone4.7936.315.66.832.47.122.482.412.422.572.712.372.512.82

Grade 3-4 Toxicity

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

InterventionParticipants (Count of Participants)
Lenalidomide 15 mg6
Lenalidomide 50 mg12

Response Rate

Number of participants with a complete or partial response according to International Working Group 2006 criteria. (NCT00867308)
Timeframe: 15 weeks

,
InterventionParticipants (Count of Participants)
Complete responsePartial response
Lenalidomide 15 mg00
Lenalidomide 50 mg02

Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)39.1
Lenalidomide and Dexamethasone Rd1828.5
Melphalan + Prednisone + Thalidomide (MPT)26.7

Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)31.5
Lenalidomide and Dexamethasone Rd1821.5
Melphalan + Prednisone + Thalidomide (MPT)22.1

Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)35.0
Lenalidomide and Dexamethasone Rd1822.1
Melphalan + Prednisone + Thalidomide (MPT)22.3

Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)59.1
Lenalidomide and Dexamethasone Rd1862.3
Melphalan + Prednisone + Thalidomide (MPT)49.1

Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)36.7
Lenalidomide and Dexamethasone Rd1828.5
Melphalan + Prednisone + Thalidomide (MPT)26.7

Kaplan Meier Estimates of Time to Treatment Failure (TTF)

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.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)16.9
Lenalidomide and Dexamethasone Rd1817.2
Melphalan + Prednisone + Thalidomide (MPT)14.1

Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis

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.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)16.9
Lenalidomide and Dexamethasone Rd1817.2
Melphalan + Prednisone + Thalidomide (MPT)14.1

Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)26.0
Lenalidomide and Dexamethasone Rd1821.0
Melphalan + Prednisone + Thalidomide (MPT)21.9

Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)

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.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)25.5
Lenalidomide and Dexamethasone Rd1820.7
Melphalan + Prednisone + Thalidomide (MPT)21.2

Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.

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

InterventionPercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)70.0
Lenalidomide and Dexamethasone Rd1869.7
Melphalan + Prednisone + Thalidomide (MPT)58.2

Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review

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

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)80.4
Lenalidomide and Dexamethasone Rd1881.6
Melphalan + Prednisone + Thalidomide (MPT)70.6

Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review

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

Interventionpercentage of particpants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)80.4
Lenalidomide and Dexamethasone Rd1874.8
Melphalan + Prednisone + Thalidomide (MPT)61.0

Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review

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

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)60.5
Lenalidomide and Dexamethasone Rd1876.8
Melphalan + Prednisone + Thalidomide (MPT)57.5

Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis

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

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)46.2
Lenalidomide and Dexamethasone Rd1853.1
Melphalan + Prednisone + Thalidomide (MPT)45.7

Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis

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

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)80.7
Lenalidomide and Dexamethasone Rd1878.6
Melphalan + Prednisone + Thalidomide (MPT)67.5

Percentage of Participants With an Objective Response Based on IRAC Review

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

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)75.1
Lenalidomide and Dexamethasone Rd1873.4
Melphalan + Prednisone + Thalidomide (MPT)62.3

Time to First Response Based on the Investigator Assessment at the Time of Final Analysis

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.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)1.8
Lenalidomide and Dexamethasone Rd181.8
Melphalan + Prednisone + Thalidomide (MPT)2.8

Time to First Response Based on the Review by the IRAC

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

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)1.8
Lenalidomide and Dexamethasone Rd181.8
Melphalan + Prednisone + Thalidomide (MPT)2.8

Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd182.9-3.3-8.6-6.4-5.1-7.5
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

Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-1.71.80.9-1.2-2.8-2.6
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

Change From Baseline in the EORTC QLQ-C30 Constipation Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd186.30.0-5.1-5.2-5.9-7.5
Lenalidomide and Low-Dose Dexamethasone (Rd)8.31.8-2.4-2.4-4.5-7.9
Melphalan + Prednisone + Thalidomide (MPT)18.413.96.83.70.0-2.2

Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd182.33.46.09.110.96.4
Lenalidomide and Low-Dose Dexamethasone (Rd)3.83.78.211.814.810.8
Melphalan + Prednisone + Thalidomide (MPT)-0.6-2.4-2.2-2.5-1.7-0.5

Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd183.6-1.9-2.9-1.62.90.8
Lenalidomide and Low-Dose Dexamethasone (Rd)0.9-0.8-2.3-3.5-1.8-1.0
Melphalan + Prednisone + Thalidomide (MPT)4.22.00.1-1.60.47.8

Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd180.13.95.84.93.13.7
Lenalidomide and Low-Dose Dexamethasone (Rd)0.63.84.64.65.82.6
Melphalan + Prednisone + Thalidomide (MPT)1.02.15.55.15.1-0.0

Change From Baseline in the EORTC QLQ-C30 Fatigue Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd184.4-3.4-5.9-2.30.1-1.6
Lenalidomide and Low-Dose Dexamethasone (Rd)2.6-2.5-3.7-4.3-3.10.3
Melphalan + Prednisone + Thalidomide (MPT)2.8-1.8-4.5-3.9-4.32.7

Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-0.3-0.4-0.31.61.80.5
Lenalidomide and Low-Dose Dexamethasone (Rd)2.11.91.40.42.01.9
Melphalan + Prednisone + Thalidomide (MPT)0.51.90.71.10.45.0

Change From Baseline in the EORTC QLQ-C30 Insomnia Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd183.2-1.3-1.91.11.4-1.6
Lenalidomide and Low-Dose Dexamethasone (Rd)2.10.2-1.2-1.0-0.5-5.2
Melphalan + Prednisone + Thalidomide (MPT)-10.5-8.9-11.6-9.6-6.0-4.5

Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-0.5-2.5-4.0-3.6-2.7-4.2
Lenalidomide and Low-Dose Dexamethasone (Rd)1.8-1.1-1.3-2.2-2.30.4
Melphalan + Prednisone + Thalidomide (MPT)4.0-1.2-3.9-3.9-3.91.0

Change From Baseline in the EORTC QLQ-C30 Pain Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation 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

Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-1.44.77.67.46.83.0
Lenalidomide and Low-Dose Dexamethasone (Rd)-1.73.44.75.06.9-0.1
Melphalan + Prednisone + Thalidomide (MPT)-0.92.25.36.98.3-0.1

Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-4.66.38.69.49.13.8
Lenalidomide and Low-Dose Dexamethasone (Rd)-2.72.46.37.88.0-0.3
Melphalan + Prednisone + Thalidomide (MPT)-2.44.18.211.814.5-1.0

Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-2.22.05.23.83.22.7
Lenalidomide and Low-Dose Dexamethasone (Rd)-4.30.74.02.94.2-1.2
Melphalan + Prednisone + Thalidomide (MPT)-1.42.43.45.86.0-3.5

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Study discontinuation
Lenalidomide and Dexamethasone Rd18-1.34.75.43.25.75.0
Lenalidomide and Low-Dose Dexamethasone (Rd)0.44.85.94.86.4-0.1
Melphalan + Prednisone + Thalidomide (MPT)1.04.36.16.54.80.3

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-1.50.81.5-0.4-0.31.8
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

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation 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

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd183.99.212.312.111.78.8
Lenalidomide and Low-Dose Dexamethasone (Rd)4.78.59.810.812.75.8
Melphalan + Prednisone + Thalidomide (MPT)3.36.38.010.09.53.2

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd184.01.2-0.41.22.3-1.0
Lenalidomide and Low-Dose Dexamethasone (Rd)2.51.01.71.92.20.6
Melphalan + Prednisone + Thalidomide (MPT)5.63.52.94.74.33.8

Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score

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

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-0.00.10.10.10.10.0
Lenalidomide and Low-Dose Dexamethasone (Rd)0.00.10.10.10.10.0
Melphalan + Prednisone + Thalidomide (MPT)0.00.10.10.10.10.0

Number of Participants With Adverse Events (AEs) During the Active Treatment Phase

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

,,
InterventionParticipants (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 Rd1853643336308501481410000269326290177000104119700051581309700064109931040008421415511800020321301280000241
Lenalidomide and Low-Dose Dexamethasone (Rd)5294535035950648242900026937334222900013117121600011195165130000951571091520009627920317000030368353319000290
Melphalan + Prednisone + Thalidomide (MPT)53948038270527004413264931454230030711831649100065521420075629427153008378146713480019947254241900328324388249

Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase

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

,,
Interventionparticipants (Number)
Normal Baseline Grade to Normal Postbaseline GradeNormal Baseline Grade to Grade 1 postbaselineNormal Baseline Grade to Grade 2 postbaselineNormal Baseline Grade to Grade 3 postbaselineNormal Baseline Grade to Grade 4 postbaselineGrade 1 Baseline to Normal postbaselineGrade1 Baseline to Grade 1 postbaselineGrade 1 Baseline to Grade 2 postbaselineGrade 1 Baseline to Grade 3 postbaselineGrade 1 Baseline to Grade 4 postbaselineGrade 2 Baseline to normal postbaselineGrade 2 Baseline to Grade 1 postbaselineGrade 2 Baseline to Grade 2 postbaselineGrade 2 Baseline to Grade 3 postbaselineGrade 2 Baseline to Grade 4 postbaselineGrade 3 Baseline to Normal postbaselineGrade 3 Baseline to Grade 1 postbaselineGrade 3 Baseline to Grade 2 postbaselineGrade 3 Baseline to Grade 3 postbaselineGrade3 Baseline to Grade 4 postbaselineGrade 4 Baseline to Normal postbaseline GradeGrade 4 Baseline to Grade 1 postbaseline GradeGrade 4 Baseline to Grade 2 postbaselineGrade 4 Baseline Grade to Grade 3 postbaselineGrade 4 Baseline to Grade 4 postbaseline
Lenalidomide and Dexamethasone Rd181338510971306111530401111850012200000
Lenalidomide and Low-Dose Dexamethasone (Rd)103961217021781725911141890022001000
Melphalan + Prednisone + Thalidomide (MPT)3779128141452211202101721100000100000

Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase

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

,,
Interventionparticipants (Number)
CrCl< 30 mL/min to CrCl< 30 mL/minCrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/minCrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/minCrCl< 30 mL/min to ≥ 80 mL/minCrCl≥ 30 but < 50 mL/min to < 30 mL/minCrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mLCrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mLCrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/minCrCl ≥ 50 but < 80 mL to CrCl< 30 mL/minCrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/minCrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/minCrCl ≥ 50 but < 80 mL to ≥ 80 mL/minCrCl ≥ 80 mL/min to CrCl< 30 mL/minCrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/minCrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/minCrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min
Lenalidomide and Dexamethasone Rd18171482241551201130991010114
Lenalidomide and Low-Dose Dexamethasone (Rd)15187213767904112107006109
Melphalan + Prednisone + Thalidomide (MPT)1919500416520410297009121

Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase

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

,,
Interventionparticipants (Number)
Normal Baseline Grade to Normal Postbaseline GradeNormal Baseline Grade to Grade 1 postbaselineNormal Baseline Grade to Grade 2 postbaselineNormal Baseline Grade to Grade 3 postbaselineNormal Baseline Grade to Grade 4 postbaselineGrade 1 Baseline to Normal postbaselineGrade 1 Baseline to Grade 1 postbaselineGrade1 Baseline to Grade 2 postbaselineGrade 1 Baseline to Grade 3 postbaselineGrade 1 Baseline to Grade 4 postbaselineGrade 2 Baseline to normal postbaselineGrade 2 Baseline to Grade 1 postbaselineGrade 2 Baseline to Grade 2 postbaselineGrade 2 Baseline to Grade 3 postbaselineGrade 2 Baseline to Grade 4 postbaselineGrade 3 Baseline to Normal postbaselineGrade 3 Baseline to Grade 1 postbaselineGrade 3 Baseline to Grade 2 postbaselineGrade 3 Baseline to Grade 3 postbaselineGrade 3 Baseline to Grade 4 postbaselineGrade 4 Baseline to Normal postbaselineGrade 4 Baseline to Grade 1 postbaselineGrade 4 Baseline to Grade 2 postbaselineGrade 4 Baseline to Grade 3 postbaselineGrade 4 Baseline to Grade 4 postbaseline
Lenalidomide and Dexamethasone Rd18103081001261231750121354190148300011
Lenalidomide and Low-Dose Dexamethasone (Rd)639800010612825208125484001210500001
Melphalan + Prednisone + Thalidomide (MPT)92541001101232040141334711001010200102

Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.

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

,,
Interventionparticipants (Number)
Normal Baseline Grade to Normal Postbaseline GradeNormal Baseline Grade to Grade 1 postbaselineNormal Baseline Grade to Grade 2 postbaselineNormal Baseline Grade to Grade 3 postbaselineNormal Baseline Grade to Grade 4 postbaselineGrade1 Baseline to Normal postbaseline GradeGrade 1 Baseline to Grade 1 postbaselineGrade 1 Baseline to Grade 2 postbaselineGrade 1 Baseline to Grade 3 postbaselineGrade 1 Baseline to Grade 4 postbaselineGrade 2 Baseline to normal postbaseline GradeGrade 2 Baseline to Grade 1 postbaselineGrade 2 Baseline to Grade 2 postbaselineGrade 2 Baseline to Grade 3 postbaselineGrade 2 Baseline to Grade 4 postbaselineGrade 3 Baseline to Normal postbaseline GradeGrade 3 Baseline to Grade 1 postbaselineGrade 3 Baseline to Grade 2 postbaselineGrade 3 Baseline to Grade 3 postbaselineGrade 3 Baseline to Grade 4 postbaseline
Lenalidomide and Dexamethasone Rd1819721130125338191210132000001
Lenalidomide and Low-Dose Dexamethasone (Rd)19721624154134151020033100002
Melphalan + Prednisone + Thalidomide (MPT)16520827311165171010212200110

Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders

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)

Interventiong/dL (Mean)
Lenalidomide6.1

Kaplan Meier Estimate for Duration of Transfusion Independence Response

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

Interventionweeks (Median)
Lenalidomide97.0

Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence

"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

Interventionparticipants (Number)
Lenalidomide59

Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study

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)

Interventionparticipant (Number)
Lenalidomide70

Time to Transfusion Independence

"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

Interventionweeks (Mean)
Lenalidomide6.2

Participant Counts of Absolute Neutrophil Count (ANC) Response

"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

Interventionparticipant (Number)
MajorMinorNone
Lenalidomide9018

Participant Counts of Cytogenetic Response

"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

Interventionparticipants (Number)
MajorMinorNone
Lenalidomide182014

Participant Counts of Platelet Response

"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

Interventionparticipants (Number)
MajorMinorNone
Lenalidomide2013

Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study

"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

Interventionparticipants (Number)
Relapsed (had a transfusion after response)Maintained transfusion independence
Lenalidomide3524

Participants With Adverse Experiences

"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

Interventionparticipants (Number)
At least one AEAt least one AE related to study drugAt least one NCI CTC grade 3-4 AEAt least one NCI CTC grade 3-4 AE related to drugAt least one serious AEAt least one serious AE related to study drugAE leading to dose reduction or interruptionAE leading to discontinuation of study drug
Lenalidomide148143140131894013147

Participants With Bone Marrow Progression

"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

Interventionparticipants (Number)
RA/RARS to RAEBRA/RARS/RAEB/CMML to AML
Lenalidomide116

Participants With Complete or Partial Bone Marrow Improvement

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

Interventionparticipants (Number)
Complete bone marrow improvementPartial bone marrow improvement
Lenalidomide2215

Major Response Rate

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

Interventionparticipants (Number)
Lenalidomide and Rituximab4

Minor Response Rate

A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels. (NCT00142168)
Timeframe: 34.3 months

Interventionparticipants (Number)
Lenalidomide and Rituximab4

Overall Response

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

Interventionparticipants (Number)
Lenalidomide and Rituximab8

Time to Progression

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

Interventionmonths (Median)
Lenalidomide and Rituximab17.1

Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)

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

InterventionParticipants (Count of Participants)
Lenalidomide + Prednisone14

Percentage of Participants With Response

"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

Interventionpercentage of participants (Number)
Lenalidomide23.3

Percentage of Participants With Tumor Control

"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

Interventionpercentage of participants (Number)
Lenalidomide60.5

Progression Free Survival (PFS)

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

Interventionmonths (Median)
Lenalidomide4.4

The Duration of Response

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

Interventionmonths (Median)
LenalidomideNA

Number of Participants With Adverse Events (AEs)

"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.

Interventionparticipants (Number)
At least one Adverse Event (AE)≥ 1 AE related to study drugGrade (GR) 3-5 AEGrade 3-5 AE related to study drugSerious adverse event (SAE)SAE related to study drugAE leading to discontinuation of study drugRelated AE leading to study drug discontinuationAE leading to dose reduction or interruption
Lenalidomide4237272418109527

Duration of Response (DOR)

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

Interventionmonths (Median)
LCD (Cyclophosphamide 300 mg/m^2)26.1
LCD (Cyclophosphamide 300 mg)NA

Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment

"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)

Interventionparticipants (Number)
LCD (Cyclophosphamide 300 mg/m^2)28
LCD (Cyclophosphamide 300 mg)16

Overall Survival (OS)

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

Interventionmonths (Median)
LCD (Cyclophosphamide 300 mg/m^2)NA
LCD (Cyclophosphamide 300 mg)NA

Progression-free Survival (PFS)

"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

Interventionmonths (Median)
LCD (Cyclophosphamide 300 mg/m^2)27
LCD (Cyclophosphamide 300 mg)NA

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia0.4
Lenalidomide - Subpopulation From UK + Ireland3.3
Lenalidomide - Subpopulation From Spain-4.5

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-1.9
Lenalidomide - Subpopulation From UK + Ireland-4.9
Lenalidomide - Subpopulation From Spain3.5

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia1.1
Lenalidomide - Subpopulation From UK + Ireland7.9
Lenalidomide - Subpopulation From Spain2.6

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia8.6
Lenalidomide - Subpopulation From UK + Ireland8.1
Lenalidomide - Subpopulation From Spain9.0

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia2.7
Lenalidomide - Subpopulation From UK + Ireland2.7
Lenalidomide - Subpopulation From Spain-0.9

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-0.2
Lenalidomide - Subpopulation From UK + Ireland-4.0
Lenalidomide - Subpopulation From Spain-0.7

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia2.6
Lenalidomide - Subpopulation From UK + Ireland5.3
Lenalidomide - Subpopulation From Spain1.0

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia2.0
Lenalidomide - Subpopulation From UK + Ireland0.8
Lenalidomide - Subpopulation From Spain0.9

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia1.1
Lenalidomide - Subpopulation From UK + Ireland-1.8
Lenalidomide - Subpopulation From Spain-2.2

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-3.8
Lenalidomide - Subpopulation From UK + Ireland2.2
Lenalidomide - Subpopulation From Spain-1.8

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia1.0
Lenalidomide - Subpopulation From UK + Ireland0.1
Lenalidomide - Subpopulation From Spain-2.2

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-3.9
Lenalidomide - Subpopulation From UK + Ireland-5.2
Lenalidomide - Subpopulation From Spain-6.6

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-3.6
Lenalidomide - Subpopulation From UK + Ireland-2.9
Lenalidomide - Subpopulation From Spain-1.8

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-2.4
Lenalidomide - Subpopulation From UK + Ireland-1.5
Lenalidomide - Subpopulation From Spain-2.6

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-5.2
Lenalidomide - Subpopulation From UK + Ireland-5.3
Lenalidomide - Subpopulation From Spain-3.1

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-4.3
Lenalidomide - Subpopulation From UK + Ireland-2.0
Lenalidomide - Subpopulation From Spain-5.3

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia-2.4
Lenalidomide - Subpopulation From UK + Ireland-1.2
Lenalidomide - Subpopulation From Spain-3.9

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia5.8
Lenalidomide - Subpopulation From UK + Ireland3.4
Lenalidomide - Subpopulation From Spain4.4

Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale

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

Interventionunits on a scale (Mean)
Lenalidomide - Subpopulation From Austria + Australia4.9
Lenalidomide - Subpopulation From UK + Ireland4.7
Lenalidomide - Subpopulation From Spain2.0

Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)

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

Interventionweeks (Mean)
Lenalidomide Plus Dexamethasone25.6

Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)

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

Interventionweeks (Mean)
Lenalidomide Plus Dexamethasone26.5

Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment

"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

Interventionparticipants (Number)
At least one treatment-emergent AE (TEAE)At least one TEAE related to study drugAt least one TEAE with severity grade of 3 or 4At least one serious AE (SAE)
Lenalidomide Plus Dexamethasone586519471340

Participants With Adverse Events of Special Interest: Peripheral Neuropathy

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

Interventionparticipants (Number)
At least one TEAE of peripheral neuropathyNeuropathy peripheralPeripheral sensory neuropathyNeuralgiaPeripheral motor neuropathyPolyneuropathySensory disturbance
Lenalidomide Plus Dexamethasone8446335221

Participants With Adverse Events of Special Interest: Venous Thromboembolic Events

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

Interventionparticipants (Number)
At least one venous thromboembolic eventDeep vein thrombosisPulmonary embolismThrombophlebitisVenous thrombosis limb
Lenalidomide Plus Dexamethasone60382371

Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)

"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

Interventionweeks (Median)
MPR+R121.6
MPR+p56.1
MPp+p55.4

Kaplan Meier Estimates for Time to Next Antimyeloma Therapy

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

Interventionweeks (Median)
MPR+R128.9
MPR+p66.1
MPp+p66.3

Kaplan Meier Estimates of Overall Survival (OS)

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

Interventionweeks (Median)
MPR+RNA
MPR+pNA
MPp+pNA

Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)

"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

Interventionweeks (Median)
MPR+R136.1
MPR+p62.1
MPp+p56.1

Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)

"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

Interventionweeks (Median)
MPR+R112.0
MPR+p32.3

Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)

"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

Interventionweeks (Median)
MPR+R148.1
MPR+p62.7
MPp+p61.3

Time to First Response

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

Interventionweeks (Mean)
MPR+R10.0
MPR+p9.3
MPp+p16.2

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale

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

,,
Interventionunits 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+p6.14.26.25.48.1
MPR+p5.68.18.88.87.2
MPR+R2.38.012.47.610.7

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale

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

,,
Interventionunits 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+p1.9-5.7-5.4-8.8-16.0
MPR+R1.7-3.7-5.0-6.2-7.8

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale

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

,,
Interventionunits 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+p1.30.7-2.7-1.4-4.0
MPR+p-2.00.1-4.4-3.0-3.5
MPR+R0.32.91.0-0.00.3

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale

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

,,
Interventionunits 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+p4.80.6-1.1-2.7-5.2
MPR+R-1.8-3.5-5.0-5.0-1.6

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale

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

,,
Interventionunits 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+p3.20.9-0.00.80.5
MPR+p1.9-1.21.4-1.41.3
MPR+R2.33.41.15.510.6

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale

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

,,
Interventionunits 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-0.02.13.8-0.01.6
MPR+p-6.4-8.5-4.3-2.3-6.3
MPR+R-2.6-1.7-4.3-5.0-3.2

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale

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

,,
Interventionunits 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+p6.85.04.76.66.9
MPR+p2.74.21.61.1-0.2
MPR+R4.88.89.08.29.9

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale

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

,,
Interventionunits 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

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale

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

,,
Interventionunits 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-1.1-0.60.7-0.5-0.6
MPR+R2.42.16.04.81.6

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale

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

,,
Interventionunits 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-1.6-6.4-2.50.9-0.6
MPR+R2.0-1.0-5.0-4.9-4.7

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale

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

,,
Interventionunits 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-0.00.70.3-0.4-1.3
MPR+p-1.3-0.7-1.4-3.0-4.2
MPR+R3.30.51.90.71.0

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale

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

,,
Interventionunits 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

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale

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

,,
Interventionunits 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+p4.52.75.13.31.1
MPR+p3.38.18.59.77.6
MPR+R1.98.28.98.610.0

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale

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

,,
Interventionunits 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+p7.46.95.65.77.1
MPR+p3.08.07.511.78.5
MPR+R1.85.79.39.712.2

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale

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

,,
Interventionunits 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+p6.06.14.16.29.8
MPR+p0.34.44.57.56.1
MPR+R5.18.310.911.813.2

Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale

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

,,
Interventionunits 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

Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale

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

,,
Interventionunits 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+p4.55.23.95.12.7
MPR+p-0.32.6-4.0-0.56.4
MPR+R2.13.87.61.03.4

Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale

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

,,
Interventionunits 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+p7.69.814.511.914.4
MPR+p4.37.76.66.37.7
MPR+R4.714.617.317.318.5

Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale

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

,,
Interventionunits 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+p0.61.80.30.3-0.9
MPR+p0.1-1.70.0-1.0-2.9
MPR+R1.30.4-1.6-3.8-2.1

Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period

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

,,
Interventionparticipants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive disease (PD)Response not evaluable (NE)
MPp+p5727007
MPR+p5994027
MPR+R151022807

Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period

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)

,,
Interventionparticipants (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+p15310775613112693686222231111151410102621551015
MPR+p15112966214513494117110292113224162419197058782139
MPR+R150137766148140871281183233138271926202071471592528

Complete Response

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

InterventionPercentage of Participants (Number)
FCR With Lenalidomide45

Overall Response Rate

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

InterventionPercentage of Participants (Number)
FCR With Lenalidomide95

Evaluation of Stringent Complete Response, Complete Response, and Very Good Partial Response Rate (sCR + CR + VGPR Rate).

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.

InterventionParticipants (Count of Participants)
Pembrolizumab + Lenalidomide11

Number of Participants Serious Adverse Events

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

InterventionParticipants (Count of Participants)
Pembrolizumab + Lenalidomide1

Number of Participants Who Progressed at 12 Months

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.

InterventionParticipants (Count of Participants)
Pembrolizumab + Lenalidomide10

Progression Free Survival (PFS)

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

Interventionmonths (Median)
Pembrolizumab + Lenalidomide27.6

CR With Complete Blood Counts (CRi) Rate

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)

Interventionparticipants (Number)
Cohort 10
Cohort 24

Cytogenetics CR Rate (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). (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

Interventionparticipants (Number)
Cohort 11
Cohort 23

Duration of CR for Complete Responders

Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence (NCT00546897)
Timeframe: 2 years

Interventionmonths (Median)
Cohort 210

Morphologic Complete Remission Rate (CRm)

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)

Interventionparticipants (Number)
Cohort 10
Cohort 23

Morphologic Leukemia Free State

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)

Interventionparticipants (Number)
Cohort 11
Cohort 210

Overall Survival (OS)

Overall survival: Defined as the date of first dose of study drug to the date of death from any cause. (NCT00546897)
Timeframe: 2 years

Interventionmonths (Median)
Cohort 24

Partial Remission Rate (PR)

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)

Interventionparticipants (Number)
Cohort 11
Cohort 20

Progression-free Survival

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

Interventionmonths (Median)
Cohort 22

Relapse Free Survival (RFS) for Complete Responders

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

Interventionmonths (Median)
Cohort 210

Safety and Tolerability (Removal From Study Due to Adverse Events)

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)]

Interventionparticipants (Number)
Cohort 11
Cohort 28

Complete Remission Rate (CRm + CRi + CRc)

"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)

,
Interventionparticipants (Number)
CRmCRiCRc
Cohort 1001
Cohort 2343

Response Rate (RR)

"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)

,
Interventionparticipants (Number)
CRmCRcCRiPR
Cohort 10101
Cohort 23340

Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance

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

InterventionParticipants (Count of Participants)
Cohort 114
Cohort 213

Time Until Progression After Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphomas With Rituximab Resistance

Progression free survival time in months (NCT00783367)
Timeframe: 9 years from enrollment of first subject

Interventionmonths (Median)
Cohort 122.2
Cohort 222.4

Reviews

12 reviews available for thalidomide and Neutropenia

ArticleYear
Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma.
    Drugs, 2017, Volume: 77, Issue:18

    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.
    Expert opinion on pharmacotherapy, 2017, Volume: 18, Issue:18

    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.
    Leukemia, 2014, Volume: 28, Issue:8

    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.
    Leukemia research, 2014, Volume: 38, Issue:9

    Topics: Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Clinical Trials, Phase II

2014
[Pomalidomide in the treatment of relapsed and refractory multiple myeloma].
    Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti, 2014, Volume: 27, Issue:5

    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.
    Journal of the National Cancer Institute, 2016, Volume: 108, Issue:3

    Topics: Disease-Free Survival; Humans; Immunosuppressive Agents; Infections; Lenalidomide; Maintenance Chemo

2016
New immunomodulatory drugs in myeloma.
    Current hematologic malignancy reports, 2011, Volume: 6, Issue:2

    Topics: Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Humans; Immunologic Factors; Lenalido

2011
Management of the adverse effects of lenalidomide in multiple myeloma.
    Advances in therapy, 2011, Volume: 28 Suppl 1

    Topics: Anemia; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillation;

2011
Role of lenalidomide in the treatment of myelodysplastic syndromes.
    Seminars in oncology, 2011, Volume: 38, Issue:5

    Topics: Anemia, Macrocytic; Antineoplastic Agents; Chromosome Deletion; Chromosomes, Human, Pair 5; Clinical

2011
Adverse effects of thalidomide administration in patients with neoplastic diseases.
    The American journal of medicine, 2004, Oct-01, Volume: 117, Issue:7

    Topics: Angiogenesis Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Clinical Trials, Phase II

2004
Immunomodulatory drugs in myelodysplastic syndromes.
    Expert opinion on investigational drugs, 2006, Volume: 15, Issue:7

    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.
    Clinical journal of oncology nursing, 2007, Volume: 11, Issue:4

    Topics: Anorexia; Antineoplastic Agents; Apoptosis; Constipation; Diarrhea; Drug Eruptions; Drug Monitoring;

2007

Trials

57 trials available for thalidomide and Neutropenia

ArticleYear
Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial.
    American journal of hematology, 2022, Volume: 97, Issue:5

    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.
    BMC cancer, 2023, Oct-14, Volume: 23, Issue:1

    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.
    The Lancet. Oncology, 2021, Volume: 22, Issue:6

    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.
    The oncologist, 2021, Volume: 26, Issue:11

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, Aug-01, Volume: 35, Issue:22

    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.
    American journal of hematology, 2017, Volume: 92, Issue:10

    Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Disease-Free Su

2017
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
    The New England journal of medicine, 2018, 09-06, Volume: 379, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Surviva

2018
Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma.
    The New England journal of medicine, 2018, 11-08, Volume: 379, Issue:19

    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.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2013, Apr-15, Volume: 19, Issue:8

    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.
    American journal of clinical oncology, 2015, Volume: 38, Issue:1

    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.
    American journal of clinical oncology, 2015, Volume: 38, Issue:1

    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.
    American journal of clinical oncology, 2015, Volume: 38, Issue:1

    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.
    American journal of clinical oncology, 2015, Volume: 38, Issue:1

    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.
    Blood, 2013, Oct-31, Volume: 122, Issue:18

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Blood, 2014, Mar-20, Volume: 123, Issue:12

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014, Mar-01, Volume: 32, Issue:7

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014, Mar-01, Volume: 32, Issue:7

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014, Mar-01, Volume: 32, Issue:7

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014, Mar-01, Volume: 32, Issue:7

    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.
    American journal of hematology, 2014, Volume: 89, Issue:11

    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.
    Leukemia & lymphoma, 2015, Volume: 56, Issue:3

    Topics: Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Drug Combination

2015
Autologous transplantation and maintenance therapy in multiple myeloma.
    The New England journal of medicine, 2014, Sep-04, Volume: 371, Issue:10

    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.
    British journal of haematology, 2015, Volume: 169, Issue:4

    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.
    PloS one, 2015, Volume: 10, Issue:4

    Topics: Adenocarcinoma; Administration, Oral; Aged; Anticoagulants; Antineoplastic Combined Chemotherapy Pro

2015
Lenalidomide is safe and active in Waldenström macroglobulinemia.
    American journal of hematology, 2015, Volume: 90, Issue:11

    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.
    The New England journal of medicine, 2015, Nov-05, Volume: 373, Issue:19

    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.
    The Lancet. Haematology, 2016, Volume: 3, Issue:3

    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.
    Blood, 2016, 05-26, Volume: 127, Issue:21

    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.
    Leukemia research, 2016, Volume: 47

    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.
    British journal of haematology, 2017, Volume: 176, Issue:2

    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.
    British journal of haematology, 2017, Volume: 176, Issue:5

    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.
    British journal of haematology, 2017, Volume: 176, Issue:5

    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.
    British journal of haematology, 2017, Volume: 176, Issue:5

    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.
    British journal of haematology, 2017, Volume: 176, Issue:5

    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.
    The Lancet. Haematology, 2017, Volume: 4, Issue:3

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008, Dec-20, Volume: 26, Issue:36

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Erythrocyte Transfusion; Female; Humans; Lena

2008
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2009, Jan-01, Volume: 15, Issue:1

    Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant

2009
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2009, Jan-01, Volume: 15, Issue:1

    Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant

2009
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2009, Jan-01, Volume: 15, Issue:1

    Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant

2009
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2009, Jan-01, Volume: 15, Issue:1

    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.
    British journal of haematology, 2009, Volume: 145, Issue:3

    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.
    Leukemia & lymphoma, 2009, Volume: 50, Issue:4

    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.
    Clinical lymphoma & myeloma, 2009, Volume: 9, Issue:2

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009, Oct-01, Volume: 27, Issue:28

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009, Nov-10, Volume: 27, Issue:32

    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.
    Cancer chemotherapy and pharmacology, 2010, Volume: 65, Issue:4

    Topics: Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bridged-Ring Compounds; Combined Modal

2010
Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis.
    Leukemia & lymphoma, 2010, Volume: 51, Issue:6

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010, Jul-01, Volume: 28, Issue:19

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010, Jul-01, Volume: 28, Issue:19

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010, Jul-01, Volume: 28, Issue:19

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010, Jul-01, Volume: 28, Issue:19

    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.
    Leukemia & lymphoma, 2011, Volume: 52, Issue:8

    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.
    International journal of clinical oncology, 2011, Volume: 16, Issue:6

    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.
    American journal of hematology, 2011, Volume: 86, Issue:8

    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.
    Leukemia & lymphoma, 2012, Volume: 53, Issue:3

    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.
    Leukemia & lymphoma, 2012, Volume: 53, Issue:9

    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.
    Leukemia & lymphoma, 2012, Volume: 53, Issue:9

    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.
    Leukemia & lymphoma, 2012, Volume: 53, Issue:9

    Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Dose

2012
Continuous lenalidomide treatment for newly diagnosed multiple myeloma.
    The New England journal of medicine, 2012, May-10, Volume: 366, Issue:19

    Topics: Administration, Oral; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disea

2012
Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus.
    Arthritis research & therapy, 2012, Dec-07, Volume: 14, Issue:6

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    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.
    Blood, 2002, Nov-01, Volume: 100, Issue:9

    Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Prot

2002
[Single-agent thalidomide for advanced and refractory multiple myeloma].
    [Rinsho ketsueki] The Japanese journal of clinical hematology, 2003, Volume: 44, Issue:6

    Topics: Aged; Aged, 80 and over; Constipation; Disease Progression; Disorders of Excessive Somnolence; Femal

2003
Thalidomide-induced severe neutropenia during treatment of multiple myeloma.
    International journal of hematology, 2004, Volume: 79, Issue:3

    Topics: Adult; Aged; Bone Marrow; Female; Granulocyte Colony-Stimulating Factor; Humans; Male; Middle Aged;

2004
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Efficacy of lenalidomide in myelodysplastic syndromes.
    The New England journal of medicine, 2005, Feb-10, Volume: 352, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anemia, Refractory; Angiogenesis Inhibitors; Bone Marrow; Female; Ge

2005
Lenalidomide therapy in myelofibrosis with myeloid metaplasia.
    Blood, 2006, Aug-15, Volume: 108, Issue:4

    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.
    International immunopharmacology, 2006, Volume: 6, Issue:7

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Dec-01, Volume: 24, Issue:34

    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.
    British journal of haematology, 2007, Volume: 138, Issue:5

    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.
    British journal of haematology, 2008, Volume: 141, Issue:1

    Topics: Adult; Aged; Antineoplastic Agents; Blood Cell Count; Dexamethasone; Dose-Response Relationship, Dru

2008
Thalidomide as salvage therapy for chronic graft-versus-host disease.
    Blood, 1995, Nov-01, Volume: 86, Issue:9

    Topics: Adolescent; Adult; Bone Marrow Transplantation; Child; Chronic Disease; Constipation; Cyclosporine;

1995
Thalidomide for treatment of patients with chronic graft-versus-host disease.
    Blood, 2000, Dec-01, Volume: 96, Issue:12

    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.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2001, Volume: 7, Issue:7

    Topics: Aged; Aged, 80 and over; Androgens; Angiogenesis Inhibitors; Dose-Response Relationship, Drug; Endot

2001

Other Studies

27 other studies available for thalidomide and Neutropenia

ArticleYear
Lenalidomide treatment of Japanese patients with myelodysplastic syndromes with 5q deletion: a post-marketing surveillance study.
    International journal of hematology, 2023, Volume: 118, Issue:4

    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
    Turkish journal of haematology : official journal of Turkish Society of Haematology, 2023, 12-05, Volume: 40, Issue:4

    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.
    Cancer medicine, 2020, Volume: 9, Issue:16

    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].
    Zhonghua nei ke za zhi, 2017, Jul-01, Volume: 56, Issue:7

    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.
    International journal of hematology, 2018, Volume: 107, Issue:5

    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.
    Advances in therapy, 2018, Volume: 35, Issue:11

    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.
    Leukemia & lymphoma, 2014, Volume: 55, Issue:11

    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.
    Leukemia & lymphoma, 2015, Volume: 56, Issue:2

    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.
    Clinical lymphoma, myeloma & leukemia, 2014, Volume: 14, Issue:5

    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.
    Leukemia research, 2015, Volume: 39, Issue:12

    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.
    Leukemia & lymphoma, 2016, Volume: 57, Issue:8

    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).
    American journal of hematology, 2016, Volume: 91, Issue:8

    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.
    Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas, 2016, Volume: 49, Issue:6

    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.
    Die Pharmazie, 2016, Volume: 71, Issue:6

    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.
    Transplant infectious disease : an official journal of the Transplantation Society, 2017, Volume: 19, Issue:1

    Topics: Antifungal Agents; Bone Marrow Transplantation; Candida albicans; Candidiasis; Chronic Disease; Fluc

2017
Lenalidomide for the treatment of resistant discoid lupus erythematosus.
    Archives of dermatology, 2009, Volume: 145, Issue:3

    Topics: Adult; Female; Humans; Lenalidomide; Lupus Erythematosus, Discoid; Neutropenia; Thalidomide

2009
Immunomodulatory derivatives induce PU.1 down-regulation, myeloid maturation arrest, and neutropenia.
    Blood, 2010, Jan-21, Volume: 115, Issue:3

    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.
    Blood, 2010, Jan-21, Volume: 115, Issue:3

    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.
    Blood, 2010, Jan-21, Volume: 115, Issue:3

    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.
    Blood, 2010, Jan-21, Volume: 115, Issue:3

    Topics: Antineoplastic Agents; Cell Differentiation; Cells, Cultured; Down-Regulation; Granulocyte Colony-St

2010
Management of myelodysplastic syndromes in the geriatric patient.
    Current hematologic malignancy reports, 2009, Volume: 4, Issue:1

    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.
    Leukemia research, 2011, Volume: 35, Issue:11

    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.
    Clinical lymphoma, myeloma & leukemia, 2012, Volume: 12, Issue:1

    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.
    Anti-cancer drugs, 2012, Volume: 23, Issue:3

    Topics: Administration, Metronomic; Adolescent; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap

2012
Drug interaction between lenalidomide and itraconazole.
    American journal of hematology, 2012, Volume: 87, Issue:3

    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.
    Leukemia & lymphoma, 2013, Volume: 54, Issue:3

    Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Dexa

2013
Thalidomide-associated thrombocytopenia.
    The Annals of pharmacotherapy, 2005, Volume: 39, Issue:11

    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?
    British journal of haematology, 2008, Volume: 140, Issue:3

    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.
    The Journal of infectious diseases, 1995, Volume: 171, Issue:2

    Topics: Animals; Candidiasis; Chlorpromazine; Female; Interleukin-1; Kidney; Klebsiella Infections; Klebsiel

1995
Safety and efficacy of thalidomide in patients with myelofibrosis with myeloid metaplasia.
    British journal of haematology, 2001, Volume: 114, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Fatigue; Feasibility Studies; Female; Follo

2001