thalidomide has been researched along with Anemia in 89 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
Anemia: A reduction in the number of circulating ERYTHROCYTES or in the quantity of HEMOGLOBIN.
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"Low-dose thalidomide and prednisone alone or combined are effective therapies in some persons with primary myelofibrosis (PMF) and anemia with or with RBC transfusion dependence." | 9.27 | Thalidomide plus prednisone with or without danazol therapy in myelofibrosis: a retrospective analysis of incidence and durability of anemia response. ( Fang, L; Hu, N; Huang, G; Li, B; Luo, X; Pan, L; Peter Gale, R; Qin, T; Qu, S; Xiao, Z; Xu, Z; Zhang, H; Zhang, P; Zhang, Y, 2018) |
"The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM)." | 9.24 | Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. ( Chen, G; Chen, WM; Eom, HS; Ervin-Haynes, A; Facon, T; Huang, SY; Hulin, C; Kim, HJ; Kim, K; Kwak, JY; Lee, JH; Lee, JJ; Lee, JO; Liu, T; Lu, J; Min, CK; Qiu, L; Shen, ZX; Yiu, W; Yoon, SS, 2017) |
"We evaluated pomalidomide with prednisone for myelofibrosis (MF) with significant anemia (hemoglobin < 10 g/dL)." | 9.19 | Phase II study of pomalidomide in combination with prednisone in patients with myelofibrosis and significant anemia. ( Cortes, J; Daver, N; Jabbour, E; Kadia, T; Kantarjian, H; Newberry, K; Pemmaraju, N; Pierce, S; Shastri, A; Verstovsek, S; Zhou, L, 2014) |
"We evaluated single agent pomalidomide for myelofibrosis-associated anemia." | 9.17 | Modest activity of pomalidomide in patients with myelofibrosis and significant anemia. ( Cortes, J; Daver, N; Jabbour, E; Kadia, T; Kantarjian, H; Konopleva, M; O'Brien, S; Pierce, S; Quintas-Cardama, A; Shastri, A; Verstovsek, S; Zhou, L, 2013) |
"This phase 1/2 study in patients with newly diagnosed multiple myeloma (N = 53) assessed CRd--carfilzomib (20, 27, or 36 mg/m2, days 1, 2, 8, 9, 15, 16 and 1, 2, 15, 16 after cycle 8), lenalidomide (25 mg/d, days 1-21), and weekly dexamethasone (40/20 mg cycles 1-4/5+)--in 28-day cycles." | 9.16 | A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma. ( Ahmed, A; Al-Zoubi, A; Anderson, T; Couriel, D; Detweiler-Short, K; Durecki, DE; Dytfeld, D; Griffith, KA; Jagannath, S; Jakubowiak, AJ; Jobkar, T; Kaminski, M; Lebovic, D; McDonnell, K; Mietzel, M; Nordgren, B; Stockerl-Goldstein, K; Vesole, DH; Vij, R, 2012) |
" Pomalidomide therapy is effective for alleviating anemia in myelofibrosis; we examined the relationship between plasma cytokine/chemokine levels and response to treatment with pomalidomide." | 9.15 | Circulating levels of MCP-1, sIL-2R, IL-15, and IL-8 predict anemia response to pomalidomide therapy in myelofibrosis. ( Begna, K; Finke, C; Lasho, T; Pardanani, A; Tefferi, A, 2011) |
"5 or 2 mg/d with or without an abbreviated course of prednisone is well tolerated in patients with myelofibrosis and active in the treatment of anemia." | 9.14 | Pomalidomide is active in the treatment of anemia associated with myelofibrosis. ( Barosi, G; Bekele, BN; Cervantes, F; Deeg, HJ; Gale, RP; Gisslinger, H; Kantarjian, HM; Kvasnicka, HM; Mesa, RA; Paquette, RL; Passamonti, F; Rivera, CE; Roboz, GJ; Tefferi, A; Thiele, J; Vardiman, JW; Verstovsek, S; Zhang, Y, 2009) |
"Lenalidomide is an immunomodulatory agent recently reported to be effective in the treatment of transfusion-dependent anemia due to low- or intermediate-1 risk myelodysplastic syndromes (MDS) associated with a deletion 5q (del 5q) cytogenetic abnormality." | 9.14 | Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality. ( Harada, H; Kimura, A; Matsuda, A; Ozawa, K; Suzuki, K; Suzuki, T; Takatoku, M; Takeshita, K; Taniwaki, M; Tohyama, K; Tsudo, M; Watanabe, M; Yanagita, S; Yoshida, Y, 2009) |
"We investigated the therapeutic activity of recombinant erythropoietin (r-EPO) in association with thalidomide in 30 patients with myelodysplastic syndromes (MDS), previously treated with r-EPO (n." | 9.12 | Combination of erythropoietin and thalidomide for the treatment of anemia in patients with myelodysplastic syndromes. ( Bodenizza, C; Falcone, A; Musto, P; Sanpaolo, G, 2006) |
"The introduction of new agents in the treatment of multiple myeloma, such as thalidomide, bortezomib, or lenalidomide, has represented an important step forward in the management of this disease, with improvement in both treatment response and patient survival." | 8.87 | Management of the adverse effects of lenalidomide in multiple myeloma. ( González Rodríguez, AP, 2011) |
"Lenalidomide has emerged as an effective therapeutic alternative for the management of anemia in lower-risk myelodysplastic syndromes (MDS)." | 8.83 | Evolving applications of lenalidomide in the management of anemia in myelodysplastic syndromes. ( List, AF, 2006) |
"Lenalidomide, an IMiD drug (a novel type of immunomodulating drug) was recently approved by the US Food and Drug Administration for the treatment of transfusion-dependent anemia in patients with myelodysplastic syndromes (MDS) and interstitial deletions of chromosome 5q [del(5q)]." | 8.83 | Lenalidomide: targeted anemia therapy for myelodysplastic syndromes. ( Baker, AF; Bellamy, W; Green, S; List, AF, 2006) |
"Multiple laboratory tests and a rigorous review of the samples, time of collection, and laboratory results revealed that only samples collected shortly after lenalidomide administration showed hemolysis." | 7.81 | Transiently Pink-Tinged Serum in a Patient With Multiple Myeloma and Anemia Undergoing Lenalidomide Treatment. ( Sofronescu, AG; Wedel, W, 2015) |
"CsA combined with thalidomide regime could improve the anemia symptom in low/int-1 risk MDS patients without del(5q)." | 7.81 | [Long- term outcome of thalidomide and cyclosporine in patients with IPSS low/intermediate- 1 myelodysplastic syndromes]. ( Fang, L; Hu, N; Li, B; Pan, L; Qin, T; Qu, S; Wang, J; Xiao, Z; Xu, Z; Zhang, H; Zhang, Y, 2015) |
"To observe the clinical effects of low-dose thalidomide (THAL) and prednisone (PRED) with or without danazol (DANA) in patients with primary myelofibrosis (PMF) associated anemia." | 7.80 | [Comparison of low-dose thalidomide and prednisone combined with or without danazol for the treatment of primary myelofibrosis-associated anemia]. ( Fang, L; Hu, N; Li, B; Pan, L; Qin, T; Qu, S; Xiao, Z; Xu, J; Xu, Z; Zhang, H; Zhang, Y, 2014) |
"The combination of lenalidomide, bortezomib and dexamethasone (RVD) has shown excellent efficacy in patients with relapsed or refractory multiple myeloma (RRMM)." | 7.79 | Lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone for heavily pretreated relapsed or refractory multiple myeloma. ( Chen, C; Jimenez-Zepeda, VH; Kukreti, V; Reece, DE; Tiedemann, R; Trudel, S, 2013) |
"Lenalidomide has been approved by the US Food and Drug Administration for the treatment of patients with myelodysplastic syndromes (MDS) with an interstitial deletion of the long arm of chromosome 5 and, more recently, in combination with dexamethasone for multiple myeloma in patients who received at least one prior therapy." | 7.73 | Practical considerations in the use of lenalidomide therapy for myelodysplastic syndromes. ( Kurtin, S; Sokol, L, 2006) |
" The most frequent adverse events ≥ grade 3 at 15 mg were 14% anemia and 43% neutropenia." | 6.80 | Lenalidomide is safe and active in Waldenström macroglobulinemia. ( Arnulf, B; Bakala, J; Banos, A; Bories, C; Brice, P; Choquet, S; Demarquette, H; Dib, M; Fouquet, G; Guidez, S; Herbaux, C; Karlin, L; Leblond, V; LeGouill, S; Leleu, X; Louni, C; Martin, A; Morel, P; Nudel, M; Ohyba, B; Petillon, MO; Poulain, S; Salles, G; Thielemans, B; Tournilhac, O, 2015) |
"Lenalidomide was generally well tolerated and no grade 4 hematologic toxicities were noted." | 6.75 | Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis. ( Baz, R; Chanan-Khan, AA; Finley-Oliver, E; Hussein, MA; Lebovic, D; Lee, K; Miller, KC; Patel, M; Sher, T; Wood, M, 2010) |
"Thalidomide was administered to 83 patients with myelodysplastic syndrome (MDS), starting at 100 mg by mouth daily and increasing to 400 mg as tolerated." | 6.70 | Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes. ( Dar, S; du Randt, M; Dutt, D; Gezer, S; Goldberg, C; Kaspar, C; Lisak, L; Loew, J; Meyer, P; Nascimben, F; Raza, A; Venugopal, P; Zeldis, J; Zorat, F, 2001) |
"Thalidomide was found to have immunosuppressive properties and it has been used in a limited number of children with cGVHD." | 6.69 | The role of thalidomide in the treatment of refractory chronic graft-versus-host disease following bone marrow transplantation in children. ( Arrigo, C; Balduzzi, A; Locasciulli, A; Miniero, R; Nesi, F; Nicolini, B; Rovelli, A; Uderzo, C; Vassallo, E, 1998) |
" The most common adverse events (incidence ≥20 %) occurring in lenalidomide recipients were thrombocytopenia and neutropenia, which were generally managed by dosage reductions and/or interruptions, and/or pharmacotherapy." | 6.49 | Lenalidomide: a review of its use in patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndrome associated with 5q chromosome deletion. ( Scott, LJ; Syed, YY, 2013) |
"Lenalidomide also has meaningful clinical activity in lower-risk patients without deletion 5q." | 6.46 | Lenalidomide in myelodysplastic syndromes: an erythropoiesis-stimulating agent or more? ( Komrokji, RS; Lancet, JE; List, AF, 2010) |
"Lenalidomide was approved by the US Food and Drug Administration (FDA) for treatment of transfusion-dependent lower-risk myelodysplastic syndrome patients with deletion (del) (5q) alone or with additional karyotype abnormalities." | 6.46 | Lenalidomide for treatment of myelodysplastic syndromes: current status and future directions. ( Komrokji, RS; List, AF, 2010) |
"Angiodysplasias are one of the reasons of gastrointestinal bleeding, whose origin is usually due to vascular malformations." | 5.43 | Therapeutic failure with thalidomide in patients with recurrent intestinal bleeding due to angiodysplasias. ( Cardaba Garcia, E; Hernando Verdugo, M; Izquierdo Navarro, Mdel C; Sanchez Sanchez, MT, 2016) |
"Low-dose thalidomide and prednisone alone or combined are effective therapies in some persons with primary myelofibrosis (PMF) and anemia with or with RBC transfusion dependence." | 5.27 | Thalidomide plus prednisone with or without danazol therapy in myelofibrosis: a retrospective analysis of incidence and durability of anemia response. ( Fang, L; Hu, N; Huang, G; Li, B; Luo, X; Pan, L; Peter Gale, R; Qin, T; Qu, S; Xiao, Z; Xu, Z; Zhang, H; Zhang, P; Zhang, Y, 2018) |
"The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM)." | 5.24 | Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. ( Chen, G; Chen, WM; Eom, HS; Ervin-Haynes, A; Facon, T; Huang, SY; Hulin, C; Kim, HJ; Kim, K; Kwak, JY; Lee, JH; Lee, JJ; Lee, JO; Liu, T; Lu, J; Min, CK; Qiu, L; Shen, ZX; Yiu, W; Yoon, SS, 2017) |
"The Intergroupe Francophone du Myélome conducted a randomized trial to compare bortezomib-thalidomide-dexamethasone (VTD) with bortezomib-cyclophosphamide-dexamethasone (VCD) as induction before high-dose therapy and autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma." | 5.22 | VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial. ( Allangba, O; Araujo, C; Attal, M; Avet-Loiseau, H; Belhadj, K; Biron, L; Brechignac, S; Caillon, H; Caillot, D; Chaleteix, C; Chaoui, D; Dejoie, T; Dib, M; Dorvaux, V; Eisenmann, JC; Escoffre, M; Facon, T; Fermand, JP; Fontan, J; Garderet, L; Glaisner, S; Godmer, P; Hulin, C; Jaccard, A; Kolb, B; Laribi, K; Lenain, P; Luycx, O; Macro, M; Malfuson, JV; Marit, G; Moreau, P; Pegourie, B; Planche, L; Puyade, M; Rodon, P; Roussel, M; Royer, B; Slama, B; Stoppa, AM; Tiab, M; Wetterwald, M, 2016) |
"We evaluated pomalidomide with prednisone for myelofibrosis (MF) with significant anemia (hemoglobin < 10 g/dL)." | 5.19 | Phase II study of pomalidomide in combination with prednisone in patients with myelofibrosis and significant anemia. ( Cortes, J; Daver, N; Jabbour, E; Kadia, T; Kantarjian, H; Newberry, K; Pemmaraju, N; Pierce, S; Shastri, A; Verstovsek, S; Zhou, L, 2014) |
"Data were obtained from a Phase II, randomized, double-blind Bayesian pick-the-winner trial of prednisone and pomalidomide in patients with MPN-associated myelofibrosis and anemia (red blood cell-transfusion dependence)." | 5.19 | Use of the Functional Assessment of Cancer Therapy--anemia in persons with myeloproliferative neoplasm-associated myelofibrosis and anemia. ( Cervantes, F; Gale, RP; Hudgens, S; Khan, ZM; Mesa, R; Passamonti, F; Rivera, C; Tefferi, A; Tencer, T; Verstovsek, S, 2014) |
"We evaluated single agent pomalidomide for myelofibrosis-associated anemia." | 5.17 | Modest activity of pomalidomide in patients with myelofibrosis and significant anemia. ( Cortes, J; Daver, N; Jabbour, E; Kadia, T; Kantarjian, H; Konopleva, M; O'Brien, S; Pierce, S; Quintas-Cardama, A; Shastri, A; Verstovsek, S; Zhou, L, 2013) |
"This phase 1/2 study in patients with newly diagnosed multiple myeloma (N = 53) assessed CRd--carfilzomib (20, 27, or 36 mg/m2, days 1, 2, 8, 9, 15, 16 and 1, 2, 15, 16 after cycle 8), lenalidomide (25 mg/d, days 1-21), and weekly dexamethasone (40/20 mg cycles 1-4/5+)--in 28-day cycles." | 5.16 | A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma. ( Ahmed, A; Al-Zoubi, A; Anderson, T; Couriel, D; Detweiler-Short, K; Durecki, DE; Dytfeld, D; Griffith, KA; Jagannath, S; Jakubowiak, AJ; Jobkar, T; Kaminski, M; Lebovic, D; McDonnell, K; Mietzel, M; Nordgren, B; Stockerl-Goldstein, K; Vesole, DH; Vij, R, 2012) |
"To compare usual care with a home-based individualized exercise program (HBIEP) in patients receiving intensive treatment for multiple myeloma (MM)and epoetin alfa therapy." | 5.16 | Effects of exercise on fatigue, sleep, and performance: a randomized trial. ( Anaissie, EJ; Coleman, EA; Coon, SK; Enderlin, C; Goodwin, JA; Kennedy, R; Lockhart, K; McNatt, P; Richards, K; Stewart, CB, 2012) |
"5 mg) pomalidomide and prednisone and pomalidomide alone (2 mg/day), for the treatment of anemia associated with myelofibrosis (MF)." | 5.15 | A phase-2 trial of low-dose pomalidomide in myelofibrosis. ( Begna, KH; Hogan, WJ; Litzow, MR; McClure, RF; Mesa, RA; Pardanani, A; Tefferi, A, 2011) |
" Pomalidomide therapy is effective for alleviating anemia in myelofibrosis; we examined the relationship between plasma cytokine/chemokine levels and response to treatment with pomalidomide." | 5.15 | Circulating levels of MCP-1, sIL-2R, IL-15, and IL-8 predict anemia response to pomalidomide therapy in myelofibrosis. ( Begna, K; Finke, C; Lasho, T; Pardanani, A; Tefferi, A, 2011) |
"Lenalidomide produces unexpected but clinically significant acute anemia in patients with WM." | 5.14 | Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. ( Anderson, KC; Baron, AD; Branagan, AR; Chu, L; Hunter, ZR; Hyman, PM; Ioakimidis, L; Kash, JJ; Munshi, NC; Musto, P; Nawfel, EL; Nunnink, JC; Patterson, CJ; Sharon, DJ; Soumerai, JD; Terjanian, TO; Treon, SP, 2009) |
"5 or 2 mg/d with or without an abbreviated course of prednisone is well tolerated in patients with myelofibrosis and active in the treatment of anemia." | 5.14 | Pomalidomide is active in the treatment of anemia associated with myelofibrosis. ( Barosi, G; Bekele, BN; Cervantes, F; Deeg, HJ; Gale, RP; Gisslinger, H; Kantarjian, HM; Kvasnicka, HM; Mesa, RA; Paquette, RL; Passamonti, F; Rivera, CE; Roboz, GJ; Tefferi, A; Thiele, J; Vardiman, JW; Verstovsek, S; Zhang, Y, 2009) |
"Lenalidomide is an immunomodulatory agent recently reported to be effective in the treatment of transfusion-dependent anemia due to low- or intermediate-1 risk myelodysplastic syndromes (MDS) associated with a deletion 5q (del 5q) cytogenetic abnormality." | 5.14 | Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality. ( Harada, H; Kimura, A; Matsuda, A; Ozawa, K; Suzuki, K; Suzuki, T; Takatoku, M; Takeshita, K; Taniwaki, M; Tohyama, K; Tsudo, M; Watanabe, M; Yanagita, S; Yoshida, Y, 2009) |
" These included Grade 3 neutropenia precluding planned paclitaxel therapy (n = 3), grade 3 gastrointestinal toxicity (n = 2), chest pain (n = 1) and pulmonary embolism (n = 1)." | 5.14 | A modular Phase I study of lenalidomide and paclitaxel in metastatic castration-resistant prostate cancer following prior taxane therapy. ( Bekele, NB; Carter, CM; Mathew, P; Pagliaro, L; Tannir, N; Tu, SM, 2010) |
"We investigated the therapeutic activity of recombinant erythropoietin (r-EPO) in association with thalidomide in 30 patients with myelodysplastic syndromes (MDS), previously treated with r-EPO (n." | 5.12 | Combination of erythropoietin and thalidomide for the treatment of anemia in patients with myelodysplastic syndromes. ( Bodenizza, C; Falcone, A; Musto, P; Sanpaolo, G, 2006) |
"We conducted a nonrandomized prospective phase II study of thalidomide in anemic patients with myelofibrosis with myeloid metaplasia (MMM), with or without preceding polycythemia vera or essential thrombocythemia, with a primary aim to improve anemia." | 5.10 | Negligible clinical effects of thalidomide in patients with myelofibrosis with myeloid metaplasia. ( Birgergård, G; Björkholm, M; Kutti, J; Maim, C; Markevärn, B; Mauritzson, N; Merup, M; Palmblad, J; Westin, J, 2002) |
"The introduction of new agents in the treatment of multiple myeloma, such as thalidomide, bortezomib, or lenalidomide, has represented an important step forward in the management of this disease, with improvement in both treatment response and patient survival." | 4.87 | Management of the adverse effects of lenalidomide in multiple myeloma. ( González Rodríguez, AP, 2011) |
"Lenalidomide, an IMiD drug (a novel type of immunomodulating drug) was recently approved by the US Food and Drug Administration for the treatment of transfusion-dependent anemia in patients with myelodysplastic syndromes (MDS) and interstitial deletions of chromosome 5q [del(5q)]." | 4.83 | Lenalidomide: targeted anemia therapy for myelodysplastic syndromes. ( Baker, AF; Bellamy, W; Green, S; List, AF, 2006) |
"Lenalidomide has emerged as an effective therapeutic alternative for the management of anemia in lower-risk myelodysplastic syndromes (MDS)." | 4.83 | Evolving applications of lenalidomide in the management of anemia in myelodysplastic syndromes. ( List, AF, 2006) |
"CsA combined with thalidomide regime could improve the anemia symptom in low/int-1 risk MDS patients without del(5q)." | 3.81 | [Long- term outcome of thalidomide and cyclosporine in patients with IPSS low/intermediate- 1 myelodysplastic syndromes]. ( Fang, L; Hu, N; Li, B; Pan, L; Qin, T; Qu, S; Wang, J; Xiao, Z; Xu, Z; Zhang, H; Zhang, Y, 2015) |
"Multiple laboratory tests and a rigorous review of the samples, time of collection, and laboratory results revealed that only samples collected shortly after lenalidomide administration showed hemolysis." | 3.81 | Transiently Pink-Tinged Serum in a Patient With Multiple Myeloma and Anemia Undergoing Lenalidomide Treatment. ( Sofronescu, AG; Wedel, W, 2015) |
"To observe the clinical effects of low-dose thalidomide (THAL) and prednisone (PRED) with or without danazol (DANA) in patients with primary myelofibrosis (PMF) associated anemia." | 3.80 | [Comparison of low-dose thalidomide and prednisone combined with or without danazol for the treatment of primary myelofibrosis-associated anemia]. ( Fang, L; Hu, N; Li, B; Pan, L; Qin, T; Qu, S; Xiao, Z; Xu, J; Xu, Z; Zhang, H; Zhang, Y, 2014) |
"The combination of lenalidomide, bortezomib and dexamethasone (RVD) has shown excellent efficacy in patients with relapsed or refractory multiple myeloma (RRMM)." | 3.79 | Lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone for heavily pretreated relapsed or refractory multiple myeloma. ( Chen, C; Jimenez-Zepeda, VH; Kukreti, V; Reece, DE; Tiedemann, R; Trudel, S, 2013) |
" Recombinant erythropoietin alfa and darbepoetin alfa have been the mainstay of therapy for treating anemia associated with MDS." | 3.74 | The costs of drugs used to treat myelodysplastic syndromes following National Comprehensive Cancer Network Guidelines. ( Cosler, LE; Ferro, SA; Greenberg, PL; Lyman, GH, 2008) |
"Lenalidomide has been approved by the US Food and Drug Administration for the treatment of patients with myelodysplastic syndromes (MDS) with an interstitial deletion of the long arm of chromosome 5 and, more recently, in combination with dexamethasone for multiple myeloma in patients who received at least one prior therapy." | 3.73 | Practical considerations in the use of lenalidomide therapy for myelodysplastic syndromes. ( Kurtin, S; Sokol, L, 2006) |
"Changes in hemoglobin (HGB) and serum albumin (SA) concentration associated with the onset of symptomatic erythema nodosum leprosum (ENL) were studied by comparing the values obtained on the day thalidomide or prednisone therapy commenced, with each patients' preceding values." | 3.71 | Decreases in mean hemoglobin and serum albumin values in erythema nodosum leprosum and lepromatous leprosy. ( Rea, TH, 2001) |
"Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib)." | 2.84 | Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. ( Casadebaig Bravo, ML; Drach, J; Fu, T; Goy, A; Habermann, TM; Kalayoglu Besisik, S; Luigi Zinzani, P; Ramchandren, R; Takeshita, K; Tuscano, JM; Witzig, TE; Zhang, L, 2017) |
" The most frequent adverse events ≥ grade 3 at 15 mg were 14% anemia and 43% neutropenia." | 2.80 | Lenalidomide is safe and active in Waldenström macroglobulinemia. ( Arnulf, B; Bakala, J; Banos, A; Bories, C; Brice, P; Choquet, S; Demarquette, H; Dib, M; Fouquet, G; Guidez, S; Herbaux, C; Karlin, L; Leblond, V; LeGouill, S; Leleu, X; Louni, C; Martin, A; Morel, P; Nudel, M; Ohyba, B; Petillon, MO; Poulain, S; Salles, G; Thielemans, B; Tournilhac, O, 2015) |
"The lenalidomide dose was adapted to the estimated glomerular filtration rate and dexamethasone was given at high dose in cycle one and at low dose thereafter." | 2.80 | Lenalidomide and dexamethasone for acute light chain-induced renal failure: a phase II study. ( Adam, Z; Autzinger, EM; Greil, R; Heintel, D; Kasparu, H; Kuehr, T; Ludwig, H; Müldür, E; Poenisch, W; Rauch, E; Weißmann, A; Zojer, N, 2015) |
"Lenalidomide was generally well tolerated and no grade 4 hematologic toxicities were noted." | 2.75 | Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis. ( Baz, R; Chanan-Khan, AA; Finley-Oliver, E; Hussein, MA; Lebovic, D; Lee, K; Miller, KC; Patel, M; Sher, T; Wood, M, 2010) |
"Lenalidomide therapy was continued indefinitely in patients exhibiting clinical benefit." | 2.74 | Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. ( Bueso-Ramos, C; Cortes, J; Ferrajoli, A; Garcia-Manero, G; Kantarjian, HM; Manshouri, T; Quintás-Cardama, A; Ravandi, F; Thomas, D; Verstovsek, S, 2009) |
"Thalidomide was administered together with current therapy to 63 patients, starting at 50 mg daily and increasing to 400 mg as tolerated." | 2.71 | Low-dose thalidomide ameliorates cytopenias and splenomegaly in myelofibrosis with myeloid metaplasia: a phase II trial. ( Balestri, F; Barosi, G; Barulli, S; Bauduer, F; Bendotti, C; Bordessoule, D; Broccia, G; Buccisano, F; Caenazzo, A; Demory, JL; Dupriez, B; Falcone, A; Gentili, S; Grossi, A; Ilariucci, F; Le Bousse-Kerdiles, MC; Marchetti, M; Pecci, A; Viarengo, G; Volpe, A, 2004) |
"Thalidomide was administered to 83 patients with myelodysplastic syndrome (MDS), starting at 100 mg by mouth daily and increasing to 400 mg as tolerated." | 2.70 | Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes. ( Dar, S; du Randt, M; Dutt, D; Gezer, S; Goldberg, C; Kaspar, C; Lisak, L; Loew, J; Meyer, P; Nascimben, F; Raza, A; Venugopal, P; Zeldis, J; Zorat, F, 2001) |
"Thalidomide was found to have immunosuppressive properties and it has been used in a limited number of children with cGVHD." | 2.69 | The role of thalidomide in the treatment of refractory chronic graft-versus-host disease following bone marrow transplantation in children. ( Arrigo, C; Balduzzi, A; Locasciulli, A; Miniero, R; Nesi, F; Nicolini, B; Rovelli, A; Uderzo, C; Vassallo, E, 1998) |
"Waldenström macroglobulinemia is defined by the presence of monoclonal immunoglobulin IgM type (M-IgM) and evidence of lymphoplasmacytic bone marrow infiltration." | 2.53 | [Changes in the prognosis and treatment of Waldenström macroglobulinemia. Literature overview and own experience]. ( Adam, Z; Král, Z; Krejčí, M; Mayer, J; Pour, L; Pourová, E; Ševčíková, E; Ševčíková, S, 2016) |
"However, as myelofibrosis is not a disease with spontaneous remissions, even non-randomized trials carry weight." | 2.50 | Does anything work for anaemia in myelofibrosis? ( Birgegård, G, 2014) |
" The most common adverse events (incidence ≥20 %) occurring in lenalidomide recipients were thrombocytopenia and neutropenia, which were generally managed by dosage reductions and/or interruptions, and/or pharmacotherapy." | 2.49 | Lenalidomide: a review of its use in patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndrome associated with 5q chromosome deletion. ( Scott, LJ; Syed, YY, 2013) |
"Lenalidomide also has meaningful clinical activity in lower-risk patients without deletion 5q." | 2.46 | Lenalidomide in myelodysplastic syndromes: an erythropoiesis-stimulating agent or more? ( Komrokji, RS; Lancet, JE; List, AF, 2010) |
"Lenalidomide was approved by the US Food and Drug Administration (FDA) for treatment of transfusion-dependent lower-risk myelodysplastic syndrome patients with deletion (del) (5q) alone or with additional karyotype abnormalities." | 2.46 | Lenalidomide for treatment of myelodysplastic syndromes: current status and future directions. ( Komrokji, RS; List, AF, 2010) |
"Median survival of patients with myelofibrosis with myeloid metaplasia (MMM) ranges from 3." | 2.41 | Prognostic factors and current practice in treatment of myelofibrosis with myeloid metaplasia: an update anno 2000. ( Cervantes, F, 2001) |
"Anemia in myelofibrosis (MF) occurs frequently, is poorly addressed by US Food and Drug Administration-approved JAK inhibitors, and negatively impacts quality of life." | 1.56 | Retrospective Analysis of the Clinical Use and Benefit of Lenalidomide and Thalidomide in Myelofibrosis. ( Al Ali, N; Castillo-Tokumori, F; Komrokji, R; Kuykendall, AT; Lancet, J; Padron, E; Sallman, D; Sweet, K; Talati, C; Yun, S, 2020) |
"Angiodysplasias are one of the reasons of gastrointestinal bleeding, whose origin is usually due to vascular malformations." | 1.43 | Therapeutic failure with thalidomide in patients with recurrent intestinal bleeding due to angiodysplasias. ( Cardaba Garcia, E; Hernando Verdugo, M; Izquierdo Navarro, Mdel C; Sanchez Sanchez, MT, 2016) |
"Multicentric Castleman's disease (MCD) is a rare lymphoproliferative disorder of unknown etiology." | 1.32 | Alleviation of systemic manifestations of multicentric Castleman's disease by thalidomide. ( Lee, FC; Merchant, SH, 2003) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (2.25) | 18.7374 |
1990's | 1 (1.12) | 18.2507 |
2000's | 28 (31.46) | 29.6817 |
2010's | 54 (60.67) | 24.3611 |
2020's | 4 (4.49) | 2.80 |
Authors | Studies |
---|---|
Buesche, G | 1 |
Teoman, H | 1 |
Schneider, RK | 1 |
Ribezzo, F | 1 |
Ebert, BL | 1 |
Giagounidis, A | 1 |
Göhring, G | 1 |
Schlegelberger, B | 1 |
Bock, O | 1 |
Ganser, A | 1 |
Aul, C | 1 |
Germing, U | 3 |
Kreipe, H | 1 |
Qu, S | 4 |
Xu, Z | 4 |
Qin, T | 4 |
Li, B | 4 |
Pan, L | 4 |
Chen, J | 1 |
Yan, X | 1 |
Wu, J | 1 |
Zhang, Y | 5 |
Zhang, P | 2 |
Gale, RP | 3 |
Xiao, Z | 4 |
Zhou, X | 1 |
Steinhardt, MJ | 1 |
Grathwohl, D | 1 |
Meckel, K | 1 |
Nickel, K | 1 |
Leicht, HB | 1 |
Krummenast, F | 1 |
Einsele, H | 1 |
Rasche, L | 1 |
Kortüm, KM | 1 |
Castillo-Tokumori, F | 1 |
Talati, C | 1 |
Al Ali, N | 2 |
Sallman, D | 1 |
Yun, S | 1 |
Sweet, K | 1 |
Padron, E | 1 |
Lancet, J | 1 |
Komrokji, R | 3 |
Kuykendall, AT | 1 |
Park, S | 3 |
Hamel, JF | 1 |
Toma, A | 3 |
Kelaidi, C | 1 |
Thépot, S | 1 |
Campelo, MD | 1 |
Santini, V | 1 |
Sekeres, MA | 2 |
Balleari, E | 1 |
Kaivers, J | 2 |
Sapena, R | 1 |
Götze, K | 1 |
Müller-Thomas, C | 1 |
Beyne-Rauzy, O | 2 |
Stamatoullas, A | 2 |
Kotsianidis, I | 1 |
Steensma, DP | 3 |
Fensterl, J | 1 |
Roboz, GJ | 2 |
Bernal, T | 1 |
Ramos, F | 1 |
Calabuig, M | 2 |
Guerci-Bresler, A | 2 |
Bordessoule, D | 3 |
Cony-Makhoul, P | 2 |
Cheze, S | 2 |
Wattel, E | 2 |
Rose, C | 2 |
Vey, N | 2 |
Gioia, D | 1 |
Ferrero, D | 1 |
Gaidano, G | 1 |
Cametti, G | 1 |
Pane, F | 1 |
Sanna, A | 1 |
Sanz, GF | 1 |
Dreyfus, F | 3 |
Fenaux, P | 4 |
Witzig, TE | 1 |
Luigi Zinzani, P | 1 |
Habermann, TM | 1 |
Tuscano, JM | 1 |
Drach, J | 1 |
Ramchandren, R | 1 |
Kalayoglu Besisik, S | 1 |
Takeshita, K | 2 |
Casadebaig Bravo, ML | 1 |
Zhang, L | 1 |
Fu, T | 1 |
Goy, A | 1 |
Luo, X | 1 |
Zhang, H | 3 |
Fang, L | 3 |
Hu, N | 3 |
Huang, G | 1 |
Peter Gale, R | 1 |
Rao, K | 1 |
Murthy, H | 1 |
Muralidhar, NS | 1 |
Rani, PK | 1 |
Ma, X | 1 |
Scott, BL | 1 |
Kiselev, P | 1 |
Sugrue, MM | 2 |
Swern, AS | 1 |
Schroeder, T | 1 |
Kündgen, A | 1 |
Kobbe, G | 1 |
Gattermann, N | 1 |
Cervantes, F | 4 |
Martinez-Trillos, A | 1 |
Burgstaller, S | 1 |
Fridrik, M | 1 |
Hojas, S | 1 |
Kühr, T | 1 |
Ludwig, H | 2 |
Mayrbäurl, B | 1 |
Pöhnl, R | 1 |
Pötscher, M | 1 |
Schlögl, E | 1 |
Zauner, D | 1 |
Thaler, J | 1 |
Gisslinger, H | 2 |
Adès, L | 1 |
Syed, YY | 1 |
Scott, LJ | 1 |
Daver, N | 2 |
Shastri, A | 2 |
Kadia, T | 2 |
Quintas-Cardama, A | 2 |
Jabbour, E | 3 |
Konopleva, M | 1 |
O'Brien, S | 1 |
Pierce, S | 2 |
Zhou, L | 2 |
Cortes, J | 4 |
Kantarjian, H | 3 |
Verstovsek, S | 6 |
Guglielmelli, P | 1 |
Vannucchi, AM | 1 |
Martín-Gómez, MA | 1 |
García-Marcos, SA | 1 |
Caba-Molina, M | 1 |
Palacios-Gómez, ME | 1 |
Gómez-Morales, M | 1 |
Claver-Ferré, C | 1 |
Rojas, SM | 1 |
Díez-Campelo, M | 1 |
Luño, E | 1 |
Cabrero, M | 1 |
Pedro, C | 1 |
Nomdedeu, B | 1 |
Cedena, T | 1 |
Arrizabalaga, B | 1 |
García, M | 1 |
Cerveró, C | 1 |
Collado, R | 1 |
Azaceta, G | 1 |
Ardanaz, MT | 1 |
Muñoz, JA | 1 |
Xicoy, B | 1 |
Rodríguez, MJ | 1 |
Bargay, J | 1 |
Morell, MJ | 1 |
Simiele, A | 1 |
del Cañizo, C | 1 |
Tefferi, A | 8 |
Hudgens, S | 1 |
Mesa, R | 1 |
Passamonti, F | 2 |
Rivera, C | 1 |
Tencer, T | 1 |
Khan, ZM | 1 |
Gkotzamanidou, M | 1 |
Terpos, E | 1 |
Kastritis, E | 1 |
Dimopoulos, MA | 1 |
Cheng, J | 1 |
Talamo, G | 1 |
Malysz, J | 1 |
Ochmann, M | 1 |
Lamy, T | 1 |
Loughran, TP | 1 |
Newberry, K | 1 |
Pemmaraju, N | 1 |
Xu, J | 1 |
Birgegård, G | 1 |
Shibayama, H | 1 |
Rauch, E | 1 |
Kuehr, T | 1 |
Adam, Z | 2 |
Weißmann, A | 1 |
Kasparu, H | 1 |
Autzinger, EM | 1 |
Heintel, D | 1 |
Greil, R | 1 |
Poenisch, W | 1 |
Müldür, E | 1 |
Zojer, N | 1 |
Wedel, W | 1 |
Sofronescu, AG | 1 |
Fouquet, G | 1 |
Guidez, S | 1 |
Petillon, MO | 1 |
Louni, C | 1 |
Ohyba, B | 1 |
Dib, M | 2 |
Poulain, S | 1 |
Herbaux, C | 1 |
Martin, A | 1 |
Thielemans, B | 1 |
Brice, P | 1 |
Choquet, S | 1 |
Bakala, J | 1 |
Bories, C | 1 |
Demarquette, H | 1 |
Nudel, M | 1 |
Tournilhac, O | 1 |
Arnulf, B | 1 |
LeGouill, S | 1 |
Morel, P | 1 |
Banos, A | 2 |
Karlin, L | 1 |
Salles, G | 1 |
Leblond, V | 1 |
Leleu, X | 1 |
Kosmider, O | 1 |
Chevret, S | 1 |
Delaunay, J | 1 |
Wickenhauser, S | 1 |
Caillot, D | 2 |
Laribi, K | 2 |
De Renzis, B | 1 |
Gardin, C | 1 |
Slama, B | 2 |
Sanhes, L | 1 |
Gruson, B | 1 |
Chouffi, B | 1 |
Salanoubat, C | 1 |
Benramdane, R | 1 |
Legros, L | 1 |
Tertian, G | 1 |
Bouabdallah, K | 1 |
Guilhot, F | 1 |
Taksin, AL | 1 |
Maloum, K | 1 |
Nimuboma, S | 1 |
Soussain, C | 1 |
Isnard, F | 1 |
Gyan, E | 1 |
Petit, R | 1 |
Lejeune, J | 1 |
Sardnal, V | 1 |
Renneville, A | 1 |
Preudhomme, C | 1 |
Fontenay, M | 1 |
Wang, J | 1 |
Bouchnita, A | 1 |
Eymard, N | 1 |
Moyo, TK | 1 |
Koury, MJ | 1 |
Volpert, V | 1 |
Pour, L | 1 |
Krejčí, M | 1 |
Ševčíková, S | 1 |
Pourová, E | 1 |
Ševčíková, E | 1 |
Král, Z | 1 |
Mayer, J | 1 |
Moreau, P | 1 |
Hulin, C | 2 |
Macro, M | 1 |
Chaleteix, C | 1 |
Roussel, M | 1 |
Garderet, L | 1 |
Royer, B | 1 |
Brechignac, S | 1 |
Tiab, M | 1 |
Puyade, M | 1 |
Escoffre, M | 1 |
Stoppa, AM | 1 |
Facon, T | 2 |
Pegourie, B | 1 |
Chaoui, D | 1 |
Jaccard, A | 1 |
Marit, G | 1 |
Godmer, P | 1 |
Luycx, O | 1 |
Eisenmann, JC | 1 |
Allangba, O | 1 |
Araujo, C | 1 |
Fontan, J | 1 |
Belhadj, K | 1 |
Wetterwald, M | 1 |
Dorvaux, V | 1 |
Fermand, JP | 1 |
Rodon, P | 1 |
Kolb, B | 1 |
Glaisner, S | 1 |
Malfuson, JV | 1 |
Lenain, P | 1 |
Biron, L | 1 |
Planche, L | 1 |
Caillon, H | 1 |
Avet-Loiseau, H | 1 |
Dejoie, T | 1 |
Attal, M | 1 |
Izquierdo Navarro, Mdel C | 1 |
Hernando Verdugo, M | 1 |
Cardaba Garcia, E | 1 |
Sanchez Sanchez, MT | 1 |
Haroun, F | 1 |
Mener, A | 1 |
Elkon, J | 1 |
Tabbara, I | 1 |
Ross, DM | 1 |
Dulmovits, BM | 1 |
Hom, J | 1 |
Narla, A | 1 |
Mohandas, N | 1 |
Blanc, L | 1 |
Lu, J | 1 |
Lee, JH | 1 |
Huang, SY | 1 |
Qiu, L | 1 |
Lee, JJ | 1 |
Liu, T | 1 |
Yoon, SS | 1 |
Kim, K | 1 |
Shen, ZX | 1 |
Eom, HS | 1 |
Chen, WM | 1 |
Min, CK | 1 |
Kim, HJ | 1 |
Lee, JO | 1 |
Kwak, JY | 1 |
Yiu, W | 1 |
Chen, G | 1 |
Ervin-Haynes, A | 1 |
Prebet, T | 1 |
Cluzeau, T | 1 |
Gore, SD | 1 |
Stahl, M | 1 |
Zeidan, AM | 1 |
Greenberg, PL | 1 |
Cosler, LE | 1 |
Ferro, SA | 1 |
Lyman, GH | 1 |
Treon, SP | 1 |
Soumerai, JD | 1 |
Branagan, AR | 1 |
Hunter, ZR | 1 |
Patterson, CJ | 1 |
Ioakimidis, L | 1 |
Chu, L | 1 |
Musto, P | 2 |
Baron, AD | 1 |
Nunnink, JC | 1 |
Kash, JJ | 1 |
Terjanian, TO | 1 |
Hyman, PM | 1 |
Nawfel, EL | 1 |
Sharon, DJ | 1 |
Munshi, NC | 1 |
Anderson, KC | 1 |
Kay, NE | 1 |
Shanafelt, TD | 1 |
Call, TG | 1 |
Wu, W | 2 |
Laplant, BR | 1 |
Abdel-Karim, A | 1 |
Frezzini, C | 1 |
Viggor, S | 1 |
Davidson, LE | 1 |
Thornhill, MH | 1 |
Yeoman, CM | 1 |
Barosi, G | 3 |
Paquette, RL | 1 |
Rivera, CE | 1 |
Deeg, HJ | 1 |
Thiele, J | 1 |
Kvasnicka, HM | 1 |
Vardiman, JW | 1 |
Bekele, BN | 1 |
Mesa, RA | 5 |
Kantarjian, HM | 3 |
Harada, H | 1 |
Watanabe, M | 1 |
Suzuki, K | 1 |
Yanagita, S | 1 |
Suzuki, T | 1 |
Yoshida, Y | 1 |
Kimura, A | 1 |
Tsudo, M | 1 |
Matsuda, A | 1 |
Tohyama, K | 1 |
Taniwaki, M | 1 |
Takatoku, M | 1 |
Ozawa, K | 2 |
Manshouri, T | 1 |
Thomas, D | 2 |
Ravandi, F | 1 |
Garcia-Manero, G | 2 |
Ferrajoli, A | 1 |
Bueso-Ramos, C | 1 |
Mathew, P | 1 |
Tannir, N | 1 |
Tu, SM | 1 |
Carter, CM | 1 |
Bekele, NB | 1 |
Pagliaro, L | 1 |
Pardanani, AD | 1 |
Hussein, K | 1 |
Schwager, S | 1 |
Litzow, MR | 3 |
Hogan, WJ | 3 |
Komrokji, RS | 2 |
List, AF | 5 |
Baz, R | 1 |
Patel, M | 1 |
Finley-Oliver, E | 1 |
Lebovic, D | 2 |
Hussein, MA | 1 |
Miller, KC | 1 |
Wood, M | 1 |
Sher, T | 1 |
Lee, K | 1 |
Chanan-Khan, AA | 1 |
Lancet, JE | 1 |
Ritchie, EK | 1 |
Lachs, MS | 1 |
Bryan, J | 1 |
Prescott, H | 1 |
Issa, JP | 1 |
Vassilieff, D | 1 |
Bardet, V | 1 |
Viguié, F | 1 |
Biemond, BJ | 1 |
Begna, KH | 1 |
Pardanani, A | 3 |
McClure, RF | 2 |
Laubach, J | 1 |
Richardson, P | 1 |
Anderson, K | 1 |
González Rodríguez, AP | 1 |
Begna, K | 1 |
Finke, C | 1 |
Lasho, T | 1 |
Cannella, L | 1 |
Latagliata, R | 1 |
Breccia, M | 1 |
Carmosino, I | 1 |
Loglisci, G | 1 |
Volpicelli, P | 1 |
Ferretti, A | 1 |
Santopietro, M | 1 |
Vozella, F | 1 |
Girmenia, C | 1 |
Cuzzola, M | 1 |
Oliva, EN | 1 |
Alimena, G | 1 |
Alexander, MP | 1 |
Nasr, SH | 1 |
Watson, DC | 1 |
Méndez, GP | 1 |
Rennke, HG | 1 |
Garrido Serrano, A | 1 |
León, R | 1 |
Sayago, M | 1 |
Márquez, JL | 1 |
Jakubowiak, AJ | 1 |
Dytfeld, D | 1 |
Griffith, KA | 1 |
Vesole, DH | 1 |
Jagannath, S | 1 |
Al-Zoubi, A | 1 |
Anderson, T | 1 |
Nordgren, B | 1 |
Detweiler-Short, K | 1 |
Stockerl-Goldstein, K | 1 |
Ahmed, A | 1 |
Jobkar, T | 1 |
Durecki, DE | 1 |
McDonnell, K | 1 |
Mietzel, M | 1 |
Couriel, D | 1 |
Kaminski, M | 1 |
Vij, R | 1 |
Jimenez-Zepeda, VH | 1 |
Reece, DE | 1 |
Trudel, S | 1 |
Chen, C | 1 |
Tiedemann, R | 1 |
Kukreti, V | 1 |
Coleman, EA | 1 |
Goodwin, JA | 1 |
Kennedy, R | 1 |
Coon, SK | 1 |
Richards, K | 1 |
Enderlin, C | 1 |
Stewart, CB | 1 |
McNatt, P | 1 |
Lockhart, K | 1 |
Anaissie, EJ | 1 |
Merup, M | 1 |
Kutti, J | 1 |
Birgergård, G | 1 |
Mauritzson, N | 1 |
Björkholm, M | 1 |
Markevärn, B | 1 |
Maim, C | 1 |
Westin, J | 1 |
Palmblad, J | 1 |
Li, CY | 1 |
Elliott, M | 2 |
Kaufmann, SH | 1 |
Wiseman, G | 1 |
Gray, LA | 1 |
Schroeder, G | 1 |
Reeder, T | 1 |
Zeldis, JB | 2 |
Giovanni, B | 1 |
Michelle, E | 1 |
Canepa, L | 1 |
Letizia, C | 1 |
Ballerini, F | 1 |
Filippo, B | 1 |
Piccaluga, PP | 1 |
Pier Paolo, P | 1 |
Visani, G | 1 |
Giuseppe, V | 1 |
Marchetti, M | 2 |
Monia, M | 1 |
Pozzato, G | 1 |
Gabriele, P | 1 |
Zorat, F | 2 |
Francesca, Z | 1 |
Ayalew, T | 1 |
Haidar, JH | 1 |
Bazarbachi, A | 1 |
Nasr, MR | 1 |
El-Sabban, ME | 1 |
Daher, R | 1 |
Lee, FC | 1 |
Merchant, SH | 1 |
WALKER, J | 1 |
WEICKER, H | 1 |
Balestri, F | 1 |
Viarengo, G | 1 |
Gentili, S | 1 |
Barulli, S | 1 |
Demory, JL | 1 |
Ilariucci, F | 1 |
Volpe, A | 1 |
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Caenazzo, A | 1 |
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Falcone, A | 2 |
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Kurtin, S | 1 |
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Nesi, F | 1 |
Balduzzi, A | 1 |
Nicolini, B | 1 |
Locasciulli, A | 1 |
Vassallo, E | 1 |
Miniero, R | 1 |
Uderzo, C | 1 |
Raza, A | 1 |
Meyer, P | 1 |
Dutt, D | 1 |
Lisak, L | 1 |
Nascimben, F | 1 |
du Randt, M | 1 |
Kaspar, C | 1 |
Goldberg, C | 1 |
Loew, J | 1 |
Dar, S | 1 |
Gezer, S | 1 |
Venugopal, P | 1 |
Zeldis, J | 1 |
Rea, TH | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
An Integrated European Platform to Conduct Translational Studies in Myelodysplastic Syndromes Based on the EuroBloodNet Infrastructure[NCT04174547] | 8,670 participants (Anticipated) | Observational | 2019-09-30 | Recruiting | |||
A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortez[NCT00737529] | Phase 2 | 134 participants (Actual) | Interventional | 2008-12-22 | Completed | ||
AZA PH GL 2003 CL 001 - Extension A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic S[NCT01186939] | Phase 3 | 40 participants (Actual) | Interventional | 2007-04-01 | Completed | ||
A Phase II, Prospective, Open Label Study (PO-MMM-PI-0011) to Determine the Safety and Efficacy of Pomalidomide (CC-4047) in Subjects With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF; Post-PV MF, or Post-ET MF)[NCT00946270] | Phase 2 | 70 participants (Actual) | Interventional | 2009-07-22 | Completed | ||
The Benefit/Risk Profile of Pegylated Proline-Interferon Alpha-2b (AOP2014) Added to the Best Available Strategy Based on Phlebotomies in Low-risk Patients With Polycythemia Vera (PV). The Low-PV Randomized Trial[NCT03003325] | Phase 2 | 127 participants (Actual) | Interventional | 2017-02-02 | Completed | ||
A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia[NCT02302469] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma[NCT01564537] | Phase 3 | 722 participants (Actual) | Interventional | 2012-08-01 | Completed | ||
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, an[NCT00689936] | Phase 3 | 1,623 participants (Actual) | Interventional | 2008-08-21 | Completed | ||
A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma[NCT03710915] | Phase 1 | 3 participants (Actual) | Interventional | 2019-01-12 | Terminated (stopped due to Company decision) | ||
Phase II Clinical Study of Zanubrutinib Combined With Bendamustine and Rituximab (ZBR) for Time-limited Treatment of Waldenstrom Macroglobulinemia[NCT05914662] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-02-15 | Recruiting | ||
Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia[NCT00142168] | Phase 2 | 16 participants (Actual) | Interventional | 2004-09-30 | Terminated (stopped due to Toxicity) | ||
A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic A[NCT00812968] | Phase 2 | 11 participants (Actual) | Interventional | 2007-09-01 | Completed | ||
Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)[NCT00352794] | Phase 2 | 40 participants (Actual) | Interventional | 2006-07-07 | Completed | ||
A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow[NCT03992170] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-12-31 | Recruiting | ||
Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment w/ Carfilzomib, Lenalidomide (Revlimid®) and Dexamethasone (CRD) in Subjects w/ Newly Diagnosed, Previously Untreated Multiple Myeloma Requiring Syst[NCT01029054] | Phase 1/Phase 2 | 53 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
Early Initiated Individualized Physical Training in Newly Diagnosed Multiple Myeloma Patients; Effects on Physical Function, Physical Activity, Quality of Life, Pain, and Bone Disease.[NCT02439112] | 102 participants (Actual) | Interventional | 2015-05-31 | Completed | |||
The Effect of Treatment With the Oral Iron Chelator Deferiprone on the Oxidative Stress of Blood Cells and on Iron Overload Status in Transfusion Dependent, Iron-overloaded Patients With Low Risk Myelodysplastic Syndrome[NCT02477631] | Phase 2 | 19 participants (Actual) | Interventional | 2016-02-29 | Completed | ||
Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.[NCT01039350] | Phase 2 | 80 participants (Actual) | Interventional | 2006-02-28 | Terminated (stopped due to It was stopped due to a lack of recruitment after 48 patients included) | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment. (NCT00737529)
Timeframe: From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Intervention | months (Median) |
---|---|
Lenalidomide | 24.43 |
Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment. (NCT00737529)
Timeframe: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.
Intervention | months (Median) |
---|---|
Lenalidomide | 16.64 |
Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir (NCT00737529)
Timeframe: From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Intervention | months (Median) |
---|---|
Lenalidomide | 5.46 |
Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Intervention | months (Median) |
---|---|
Lenalidomide | 4.01 |
Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Intervention | months (Median) |
---|---|
Lenalidomide | 3.75 |
Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months
Intervention | months (Median) |
---|---|
Lenalidomide | 19.50 |
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00737529)
Timeframe: From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide | 29.9 |
The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow. (NCT00737529)
Timeframe: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide | 9.0 |
Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu. (NCT00737529)
Timeframe: From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Intervention | months (Median) |
---|---|
Lenalidomide | 3.9 |
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. (NCT00737529)
Timeframe: From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Intervention | months (Median) |
---|---|
Lenalidomide | 3.5 |
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. (NCT00737529)
Timeframe: From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)
Intervention | participants (Number) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any TEAE | Any TEAE Related to Investigational Product (IP) | Any TEAE Grade 3-5 AE | Any TEAE Grade 3 AE | Any TEAE Grade 4 AE | Any TEAE Grade 5 AE | Any Grade 3-5 AE Related to IP | Any Grade 3 AE Related to IP | Any Grade 4 AE Related to IP | Any Grade 5 AE Related to IP | Any TEAE Serious Adverse Event (SAE) | Any SAE Related to IP | Any TEAE Leading to Stopping of IP | Any Treatment Related AE Leading to Stopping IP | Any AE Leading to Dose Reduction | Any AE Leading to IP Interruption | Any Treatment Related AE Leading to Dose Reduction | Treatment Related AE Leading to IP Interruption | |
Lenalidomide | 132 | 118 | 106 | 101 | 57 | 18 | 90 | 88 | 41 | 2 | 70 | 30 | 28 | 16 | 55 | 81 | 52 | 66 |
Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption. (NCT01186939)
Timeframe: 43- 68 months
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Participants with >=1 treatment emergent AE (TEAE) | Participants with >=1 treatment related TEAE | Participants with >=1 serious TEAE | Participants with >=1 serious trtment related TEAE | Participants w TEAE leading to discontinued treat | Participants w TEAE leading to dose reduction | Participants w TEAE leading to dose interruption | |
Azacitidine | 39 | 27 | 20 | 5 | 15 | 4 | 15 |
Primary endpoint is best overall response. An evaluable subject classified as a treatment success for the primary endpoint if the subject's best overall response is clinical improvement (CI) as determined by International Working Group Criteria over the first 6 cycles of study treatment. International Working Group (IWG) consensus criteria for treatment response in myelofibrosis - Clinical improvement (CI) in anemia 1/ A minimum 20g/L increase in hemoglobin level or 2. becoming transfusion independent for at least 8 week duration. (NCT00946270)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|---|
Group 1 CC-4047 | 0 |
Group 2 | 3 |
Group 3 CC-4047 + Prednisone | 6 |
DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 38 months
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 26.0 |
Placebo + Lenalidomide + Dexamethasone | 21.7 |
Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported for high-risk participants. (NCT01564537)
Timeframe: From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 46.9 |
Placebo + Lenalidomide + Dexamethasone | 30.9 |
ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months(approximate median follow-up 15 months)
Intervention | percentage of participants (Number) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 78.3 |
Placebo + Lenalidomide + Dexamethasone | 71.5 |
Data is reported for percentage of participants defined by polymorphism defined by polymorphisms in proteasome genes, such as polymorphism P11A in PSMB1 gene. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
Intervention | percentage of participants (Number) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 80.3 |
Placebo + Lenalidomide + Dexamethasone | 75.7 |
Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. (NCT01564537)
Timeframe: From date of randomization until death (up to approximately 97 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 53.6 |
Placebo + Lenalidomide + Dexamethasone | 51.6 |
Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17). (NCT01564537)
Timeframe: From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 42.2 |
Placebo + Lenalidomide + Dexamethasone | 29.4 |
Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
Intervention | percentage of participants (Number) |
---|---|
Ixazomib + Lenalidomide + Dexamethasone | 48.1 |
Placebo + Lenalidomide + Dexamethasone | 39.0 |
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. (NCT01564537)
Timeframe: From date of randomization until disease progression or death up to approximately 38 months (approximate median follow-up 15 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 18.7 |
Placebo + Lenalidomide + Dexamethasone | 9.3 |
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed. (NCT01564537)
Timeframe: From date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 20.6 |
Placebo + Lenalidomide + Dexamethasone | 14.7 |
TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 22.4 |
Placebo + Lenalidomide + Dexamethasone | 17.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Global Health Index: Baseline | Global Health Index: End of Treatment | Physical Functioning: Baseline | Physical Functioning: EOT | Role Functioning: Baseline | Role Functioning: EOT | Emotional Functioning: Baseline | Emotional Functioning: EOT | Cognitive Functioning: Baseline | Cognitive Functioning: EOT | Social Functioning: Baseline | Social Functioning: EOT | Fatigue: Baseline | Fatigue: EOT | Pain: Baseline | Pain: EOT | Nausea and Vomiting: Baseline | Nausea and Vomiting: EOT | Dyspnea: Baseline | Dyspnea: EOT | Insomnia: Baseline | Insomnia: EOT | Appetite Loss: Baseline | Appetite Loss: EOT | Constipation: Baseline | Constipation: EOT | Diarrhea: Baseline | Diarrhea: EOT | Financial Difficulties: Baseline | Financial Difficulties: EOT | |
Ixazomib+ Lenalidomide + Dexamethasone | 58.4 | -6.0 | 70.0 | -4.7 | 68.4 | -8.6 | 75.1 | -2.1 | 81.9 | -7.6 | 77.9 | -6.9 | 38.4 | 6.0 | 38.0 | 2.7 | 5.0 | 3.4 | 21.2 | 5.7 | 27.4 | 0.9 | 16.9 | 4.7 | 12.2 | -1.3 | 6.3 | 17.2 | 16.7 | 0.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Global Health Index: Baseline | Global Health Index: End of Treatment | Global Health Index: Last Follow-up | Physical Functioning: Baseline | Physical Functioning: EOT | Physical Functioning: Last Follow-up | Role Functioning: Baseline | Role Functioning: EOT | Role Functioning: Last Follow-up | Emotional Functioning: Baseline | Emotional Functioning: EOT | Emotional Functioning: Last Follow-up | Cognitive Functioning: Baseline | Cognitive Functioning: EOT | Cognitive Functioning: Last Follow-up | Social Functioning: Baseline | Social Functioning: EOT | Social Functioning: Last Follow-up | Fatigue: Baseline | Fatigue: EOT | Fatigue: Last Follow-up | Pain: Baseline | Pain: EOT | Pain: Last Follow-up | Nausea and Vomiting: Baseline | Nausea and Vomiting: EOT | Nausea and Vomiting: Last Follow-up | Dyspnea: Baseline | Dyspnea: EOT | Dyspnea: Last Follow-up | Insomnia: Baseline | Insomnia: EOT | Insomnia: Last Follow-up | Appetite Loss: Baseline | Appetite Loss: EOT | Appetite Loss: Last Follow-up | Constipation: Baseline | Constipation: EOT | Constipation: Last Follow-up | Diarrhea: Baseline | Diarrhea: EOT | Diarrhea: Last Follow-up | Financial Difficulties: Baseline | Financial Difficulties: EOT | Financial Difficulties: Last Follow-up | |
Placebo + Lenalidomide + Dexamethasone | 56.4 | -6.0 | 16.7 | 67.3 | -6.2 | 0.0 | 64.4 | -8.6 | -16.7 | 75.3 | -6.1 | -25.0 | 81.6 | -5.8 | -50.0 | 75.3 | -7.9 | 0.0 | 39.5 | 6.7 | 22.2 | 38.5 | 3.8 | 0.0 | 6.0 | 0.6 | 33.3 | 23.7 | 2.3 | 0.0 | 30.5 | -0.5 | 33.3 | 15.3 | 6.5 | 0.0 | 13.5 | 2.2 | 33.3 | 8.1 | 10.8 | 0.0 | 18.6 | 1.3 | -33.3 |
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Disease Symptoms: Baseline | Disease Symptoms: EOT | Side Effects of Treatment: Baseline | Side Effects of Treatment: EOT | Side Effects of Treatment: Last Follow-up | Body Image: Baseline | Body Image: EOT | Body Image: Last Follow-up | Future Perspective: Baseline | Future Perspective: EOT | Future Perspective: Last Follow-up | |
Placebo + Lenalidomide + Dexamethasone | 30.41 | -2.58 | 17.97 | 4.43 | 37.04 | 79.48 | -5.38 | -33.3 | 60.26 | -2.75 | -11.11 |
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Disease Symptoms: Baseline | Disease Symptoms: EOT | Disease Symptoms: Last Follow-up | Side Effects of Treatment: Baseline | Side Effects of Treatment: EOT | Body Image: Baseline | Body Image: EOT | Future Perspective: Baseline | Future Perspective: EOT | |
Ixazomib+ Lenalidomide + Dexamethasone | 29.71 | -2.35 | 1.11 | 17.23 | 4.52 | 78.00 | -0.27 | 56.99 | 2.76 |
Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. (NCT01564537)
Timeframe: From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months
Intervention | Participants (Count of Participants) | |
---|---|---|
TEAEs | SAEs | |
Ixazomib+ Lenalidomide + Dexamethasone | 359 | 205 |
Placebo + Lenalidomide + Dexamethasone | 357 | 201 |
"Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (worst, least, average, and now [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst)." (NCT01564537)
Timeframe: Baseline and end of treatment (EOT) (up to approximately 38 months)
Intervention | Participants (Count of Participants) | |
---|---|---|
Baseline | EOT | |
Ixazomib+ Lenalidomide + Dexamethasone | 345 | 145 |
Placebo + Lenalidomide + Dexamethasone | 351 | 153 |
(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
Intervention | μg/mL (Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 Day 1, 1 Hour Post-Dose | Cycle 1 Day 1, 4 Hours Post-Dose | Cycle 1 Day 14, Pre-Dose | Cycle 2 Day 1, Pre-Dose | Cycle 2 Day 14, Pre-Dose | Cycle 3 Day 1, Pre-Dose | Cycle 4 Day 1, Pre-Dose | Cycle 5 Day 1, Pre-Dose | Cycle 6 Day 1, Pre-Dose | Cycle 7 Day 1, Pre-Dose | Cycle 8 Day 1, Pre-Dose | Cycle 9 Day 1, Pre-Dose | Cycle 10 Day 1, Pre-Dose | |
Placebo + Lenalidomide + Dexamethasone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
Intervention | μg/mL (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 Day 1 | Cycle 1 Day 1, 1 Hour Post-Dose | Cycle 1 Day 1, 4 Hours Post-Dose | Cycle 1 Day 14, Pre-Dose | Cycle 2 Day 1, Pre-Dose | Cycle 2 Day 14, Pre-Dose | Cycle 3 Day 1, Pre-Dose | Cycle 4 Day 1, Pre-Dose | Cycle 5 Day 1, Pre-Dose | Cycle 6 Day 1, Pre-Dose | Cycle 7 Day 1, Pre-Dose | Cycle 8 Day 1, Pre-Dose | Cycle 9 Day 1, Pre-Dose | Cycle 10 Day 1, Pre-Dose | |
Ixazomib+ Lenalidomide + Dexamethasone | 4.79 | 36.3 | 15.6 | 6.83 | 2.4 | 7.12 | 2.48 | 2.41 | 2.42 | 2.57 | 2.71 | 2.37 | 2.51 | 2.82 |
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 39.1 |
Lenalidomide and Dexamethasone Rd18 | 28.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 31.5 |
Lenalidomide and Dexamethasone Rd18 | 21.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 22.1 |
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 35.0 |
Lenalidomide and Dexamethasone Rd18 | 22.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 22.3 |
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 59.1 |
Lenalidomide and Dexamethasone Rd18 | 62.3 |
Melphalan + Prednisone + Thalidomide (MPT) | 49.1 |
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 36.7 |
Lenalidomide and Dexamethasone Rd18 | 28.5 |
Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
Lenalidomide and Dexamethasone Rd18 | 17.2 |
Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
Lenalidomide and Dexamethasone Rd18 | 17.2 |
Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 26.0 |
Lenalidomide and Dexamethasone Rd18 | 21.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 21.9 |
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 25.5 |
Lenalidomide and Dexamethasone Rd18 | 20.7 |
Melphalan + Prednisone + Thalidomide (MPT) | 21.2 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | Percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 70.0 |
Lenalidomide and Dexamethasone Rd18 | 69.7 |
Melphalan + Prednisone + Thalidomide (MPT) | 58.2 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
Lenalidomide and Dexamethasone Rd18 | 81.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 70.6 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of particpants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
Lenalidomide and Dexamethasone Rd18 | 74.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 61.0 |
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 60.5 |
Lenalidomide and Dexamethasone Rd18 | 76.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 57.5 |
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 46.2 |
Lenalidomide and Dexamethasone Rd18 | 53.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 45.7 |
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.7 |
Lenalidomide and Dexamethasone Rd18 | 78.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 67.5 |
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | percentage of participants (Number) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 75.1 |
Lenalidomide and Dexamethasone Rd18 | 73.4 |
Melphalan + Prednisone + Thalidomide (MPT) | 62.3 |
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
Lenalidomide and Dexamethasone Rd18 | 1.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | months (Median) |
---|---|
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
Lenalidomide and Dexamethasone Rd18 | 1.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 2.9 | -3.3 | -8.6 | -6.4 | -5.1 | -7.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.3 | -5.9 | -9.8 | -7.3 | -8.1 | -1.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | -6.2 | -13.5 | -10.5 | -12.2 | -2.6 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -1.7 | 1.8 | 0.9 | -1.2 | -2.8 | -2.6 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.2 | -0.7 | -0.9 | -1.6 | -2.2 | -4.9 |
Melphalan + Prednisone + Thalidomide (MPT) | -1.8 | -1.5 | -0.3 | -0.6 | -0.7 | -7.1 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 6.3 | 0.0 | -5.1 | -5.2 | -5.9 | -7.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 8.3 | 1.8 | -2.4 | -2.4 | -4.5 | -7.9 |
Melphalan + Prednisone + Thalidomide (MPT) | 18.4 | 13.9 | 6.8 | 3.7 | 0.0 | -2.2 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 2.3 | 3.4 | 6.0 | 9.1 | 10.9 | 6.4 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 3.8 | 3.7 | 8.2 | 11.8 | 14.8 | 10.8 |
Melphalan + Prednisone + Thalidomide (MPT) | -0.6 | -2.4 | -2.2 | -2.5 | -1.7 | -0.5 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 3.6 | -1.9 | -2.9 | -1.6 | 2.9 | 0.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.9 | -0.8 | -2.3 | -3.5 | -1.8 | -1.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 4.2 | 2.0 | 0.1 | -1.6 | 0.4 | 7.8 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 0.1 | 3.9 | 5.8 | 4.9 | 3.1 | 3.7 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.6 | 3.8 | 4.6 | 4.6 | 5.8 | 2.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 2.1 | 5.5 | 5.1 | 5.1 | -0.0 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 4.4 | -3.4 | -5.9 | -2.3 | 0.1 | -1.6 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.6 | -2.5 | -3.7 | -4.3 | -3.1 | 0.3 |
Melphalan + Prednisone + Thalidomide (MPT) | 2.8 | -1.8 | -4.5 | -3.9 | -4.3 | 2.7 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -0.3 | -0.4 | -0.3 | 1.6 | 1.8 | 0.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 1.9 | 1.4 | 0.4 | 2.0 | 1.9 |
Melphalan + Prednisone + Thalidomide (MPT) | 0.5 | 1.9 | 0.7 | 1.1 | 0.4 | 5.0 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 3.2 | -1.3 | -1.9 | 1.1 | 1.4 | -1.6 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 0.2 | -1.2 | -1.0 | -0.5 | -5.2 |
Melphalan + Prednisone + Thalidomide (MPT) | -10.5 | -8.9 | -11.6 | -9.6 | -6.0 | -4.5 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -0.5 | -2.5 | -4.0 | -3.6 | -2.7 | -4.2 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 | -1.1 | -1.3 | -2.2 | -2.3 | 0.4 |
Melphalan + Prednisone + Thalidomide (MPT) | 4.0 | -1.2 | -3.9 | -3.9 | -3.9 | 1.0 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -4.4 | -13.1 | -16.1 | -14.7 | -12.4 | -7.9 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -5.4 | -13.4 | -14.4 | -14.0 | -14.4 | -8.0 |
Melphalan + Prednisone + Thalidomide (MPT) | -7.8 | -12.1 | -13.4 | -14.3 | -14.7 | -6.0 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -1.4 | 4.7 | 7.6 | 7.4 | 6.8 | 3.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.7 | 3.4 | 4.7 | 5.0 | 6.9 | -0.1 |
Melphalan + Prednisone + Thalidomide (MPT) | -0.9 | 2.2 | 5.3 | 6.9 | 8.3 | -0.1 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -4.6 | 6.3 | 8.6 | 9.4 | 9.1 | 3.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -2.7 | 2.4 | 6.3 | 7.8 | 8.0 | -0.3 |
Melphalan + Prednisone + Thalidomide (MPT) | -2.4 | 4.1 | 8.2 | 11.8 | 14.5 | -1.0 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -2.2 | 2.0 | 5.2 | 3.8 | 3.2 | 2.7 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.3 | 0.7 | 4.0 | 2.9 | 4.2 | -1.2 |
Melphalan + Prednisone + Thalidomide (MPT) | -1.4 | 2.4 | 3.4 | 5.8 | 6.0 | -3.5 |
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Study discontinuation | |
Lenalidomide and Dexamethasone Rd18 | -1.3 | 4.7 | 5.4 | 3.2 | 5.7 | 5.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.4 | 4.8 | 5.9 | 4.8 | 6.4 | -0.1 |
Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 4.3 | 6.1 | 6.5 | 4.8 | 0.3 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -1.5 | 0.8 | 1.5 | -0.4 | -0.3 | 1.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.5 | -1.7 | -1.4 | -1.4 | -2.3 | -5.6 |
Melphalan + Prednisone + Thalidomide (MPT) | -1.6 | -3.0 | -2.8 | -2.6 | -1.1 | -5.6 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -4.1 | -10.0 | -9.9 | -8.7 | -6.2 | -4.5 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.0 | -9.1 | -8.8 | -7.8 | -8.7 | -3.5 |
Melphalan + Prednisone + Thalidomide (MPT) | -4.4 | -7.0 | -7.9 | -6.5 | -7.9 | -3.7 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 3.9 | 9.2 | 12.3 | 12.1 | 11.7 | 8.8 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 4.7 | 8.5 | 9.8 | 10.8 | 12.7 | 5.8 |
Melphalan + Prednisone + Thalidomide (MPT) | 3.3 | 6.3 | 8.0 | 10.0 | 9.5 | 3.2 |
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | 4.0 | 1.2 | -0.4 | 1.2 | 2.3 | -1.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.5 | 1.0 | 1.7 | 1.9 | 2.2 | 0.6 |
Melphalan + Prednisone + Thalidomide (MPT) | 5.6 | 3.5 | 2.9 | 4.7 | 4.3 | 3.8 |
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit | |
Lenalidomide and Dexamethasone Rd18 | -0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
Melphalan + Prednisone + Thalidomide (MPT) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. (NCT00689936)
Timeframe: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | Participants (Number) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
≥ 1 adverse event (AE) | ≥ 1 grade (Gr) 3 or 4 AE | ≥ 1 grade (Gr) 5 AE | ≥ 1 serious adverse event (SAE) | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | ≥ 1 AE related to Lenalidomide | ≥ 1 AE related to dexamethasone | ≥ 1 AE related to melphalan | ≥ 1 AE related to prednisone | ≥ 1 AE related to thalidomide | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 grade 3 or 4 AE related to Lenalidomide | ≥ 1 grade 3 or 4 AE related to dexamethasone | ≥ 1 grade 3 or 4 AE related to melphalan | ≥ 1 grade 3 or 4 AE related to prednisone | ≥ 1 grade 3 or 4 AE related to Thalidomide | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Lenalidomide | ≥ 1 Grade 5 AE related to Dexamethasone | ≥ 1 Grade 5 AE related to melphalan | ≥ 1 Grade 5 AE related to prednisone | ≥ 1 Grade 5 AE related to Thalidomide | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | ≥1 SAE related to Lenalidomide | ≥1 SAE related to dexamethasone | ≥1 SAE related to melphalan | ≥1 SAE related to prednisone | ≥1 SAE related to thalidomide | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | ≥1 AE leading to Lenalidomide withdrawal | ≥1 AE leading to dexamethasone withdrawal | ≥1 AE leading to melphalan withdrawal | ≥1 AE leading to prednisone withdrawal | ≥1 AE leading to Thalidomide withdrawal | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | ≥1 AE leading to Lenalidomide reduction | ≥1 AE leading to dexamethasone reduction | ≥1 AE leading to melphalan reduction | ≥1 AE leading to prednisone reduction | ≥1 AE leading to thalidomide reduction | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | ≥1 AE leading to Rd or MPT interruption | ≥1 AE leading to Lenalidomide interruption | ≥1 AE leading to dexamethasone interruption | ≥1 AE leading to melphalan interruption | ≥1 AE leading to prednisone interruption | ≥1 AE leading to Thalidomide interruption | ≥1 AE leading to Len and Dex or MPT interruption | |
Lenalidomide and Dexamethasone Rd18 | 536 | 433 | 36 | 308 | 501 | 481 | 410 | 0 | 0 | 0 | 269 | 326 | 290 | 177 | 0 | 0 | 0 | 104 | 11 | 9 | 7 | 0 | 0 | 0 | 5 | 158 | 130 | 97 | 0 | 0 | 0 | 64 | 109 | 93 | 104 | 0 | 0 | 0 | 84 | 214 | 155 | 118 | 0 | 0 | 0 | 20 | 321 | 301 | 280 | 0 | 0 | 0 | 241 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 529 | 453 | 50 | 359 | 506 | 482 | 429 | 0 | 0 | 0 | 269 | 373 | 342 | 229 | 0 | 0 | 0 | 131 | 17 | 12 | 16 | 0 | 0 | 0 | 11 | 195 | 165 | 130 | 0 | 0 | 0 | 95 | 157 | 109 | 152 | 0 | 0 | 0 | 96 | 279 | 203 | 170 | 0 | 0 | 0 | 30 | 368 | 353 | 319 | 0 | 0 | 0 | 290 |
Melphalan + Prednisone + Thalidomide (MPT) | 539 | 480 | 38 | 270 | 527 | 0 | 0 | 441 | 326 | 493 | 145 | 423 | 0 | 0 | 307 | 118 | 316 | 49 | 10 | 0 | 0 | 6 | 5 | 5 | 2 | 142 | 0 | 0 | 75 | 62 | 94 | 27 | 153 | 0 | 0 | 83 | 78 | 146 | 71 | 348 | 0 | 0 | 199 | 47 | 254 | 2 | 419 | 0 | 0 | 328 | 324 | 388 | 249 |
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline Grade | Grade 4 Baseline to Grade 1 postbaseline Grade | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline Grade to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline | |
Lenalidomide and Dexamethasone Rd18 | 133 | 85 | 109 | 71 | 30 | 6 | 11 | 15 | 30 | 4 | 0 | 1 | 11 | 18 | 5 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 103 | 96 | 121 | 70 | 21 | 7 | 8 | 17 | 25 | 9 | 1 | 1 | 14 | 18 | 9 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
Melphalan + Prednisone + Thalidomide (MPT) | 37 | 79 | 128 | 141 | 45 | 2 | 2 | 11 | 20 | 21 | 0 | 1 | 7 | 21 | 10 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CrCl< 30 mL/min to CrCl< 30 mL/min | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl< 30 mL/min to ≥ 80 mL/min | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min | |
Lenalidomide and Dexamethasone Rd18 | 17 | 14 | 8 | 2 | 2 | 41 | 55 | 12 | 0 | 1 | 130 | 99 | 1 | 0 | 10 | 114 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 15 | 18 | 7 | 2 | 1 | 37 | 67 | 9 | 0 | 4 | 112 | 107 | 0 | 0 | 6 | 109 |
Melphalan + Prednisone + Thalidomide (MPT) | 19 | 19 | 5 | 0 | 0 | 41 | 65 | 2 | 0 | 4 | 102 | 97 | 0 | 0 | 9 | 121 |
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade 1 Baseline to Grade 1 postbaseline | Grade1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline | Grade 4 Baseline to Grade 1 postbaseline | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline | |
Lenalidomide and Dexamethasone Rd18 | 10 | 30 | 8 | 1 | 0 | 0 | 126 | 123 | 17 | 5 | 0 | 12 | 135 | 41 | 9 | 0 | 1 | 4 | 8 | 3 | 0 | 0 | 0 | 1 | 1 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 6 | 39 | 8 | 0 | 0 | 0 | 106 | 128 | 25 | 2 | 0 | 8 | 125 | 48 | 4 | 0 | 0 | 12 | 10 | 5 | 0 | 0 | 0 | 0 | 1 |
Melphalan + Prednisone + Thalidomide (MPT) | 9 | 25 | 4 | 1 | 0 | 0 | 110 | 123 | 20 | 4 | 0 | 14 | 133 | 47 | 11 | 0 | 0 | 10 | 10 | 2 | 0 | 0 | 1 | 0 | 2 |
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Intervention | participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade1 Baseline to Normal postbaseline Grade | Grade 1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline Grade | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline Grade | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline | |
Lenalidomide and Dexamethasone Rd18 | 197 | 211 | 30 | 12 | 5 | 3 | 38 | 19 | 12 | 1 | 0 | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 1 |
Lenalidomide and Low-Dose Dexamethasone (Rd) | 197 | 216 | 24 | 15 | 4 | 1 | 34 | 15 | 10 | 2 | 0 | 0 | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 2 |
Melphalan + Prednisone + Thalidomide (MPT) | 165 | 208 | 27 | 31 | 11 | 6 | 51 | 7 | 10 | 1 | 0 | 2 | 1 | 2 | 2 | 0 | 0 | 1 | 1 | 0 |
Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels. (NCT00142168)
Timeframe: 34.3 months
Intervention | participants (Number) |
---|---|
Lenalidomide and Rituximab | 4 |
A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels. (NCT00142168)
Timeframe: 34.3 months
Intervention | participants (Number) |
---|---|
Lenalidomide and Rituximab | 4 |
Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study. (NCT00142168)
Timeframe: 34.3 months
Intervention | participants (Number) |
---|---|
Lenalidomide and Rituximab | 8 |
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir. (NCT00142168)
Timeframe: 34.3 months
Intervention | months (Median) |
---|---|
Lenalidomide and Rituximab | 17.1 |
Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | 1/h (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 0.213 |
Lenalidomide: Day 4 | 0.194 |
Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | mL/minute (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 189.8 |
Lenalidomide: Day 4 | 189.9 |
Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | liters (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 53.6 |
Lenalidomide: Day 4 | 58.6 |
Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1. (NCT00812968)
Timeframe: Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.
Intervention | ng*h/mL (Geometric Mean) |
---|---|
Lenalidomide | 878.0 |
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | ng*h/mL (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 718.4 |
Lenalidomide: Day 4 | 803.5 |
Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.
Intervention | ng*h/mL (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 866.5 |
Lenalidomide: Day 4 | 877.9 |
Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | ng/mL (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 136 |
Lenalidomide: Day 4 | 149 |
The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | hours (Geometric Mean) |
---|---|
Lenalidomide: Day 1 | 3.26 |
Lenalidomide: Day 4 | 3.57 |
Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.
Intervention | hours (Median) |
---|---|
Lenalidomide: Day 1 | 2.52 |
Lenalidomide: Day 4 | 2.93 |
Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders. (NCT00812968)
Timeframe: Baseline and from Day1 until the maximum observed value (up to 155 weeks)
Intervention | g/dL (Median) | ||
---|---|---|---|
Baseline concentration | Maximum concentration during study | Change from Baseline to maximum value | |
Lenalidomide | 7.0 | 13.1 | 6.0 |
Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).
Intervention | Percentage of Bone Marrow Erythroblasts (Median) | |
---|---|---|
Change from Baseline at the end of Cycle 3 | Change from Baseline at the end of Cycle 6 | |
Lenalidomide | 36.5 | 21.5 |
Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response. (NCT00812968)
Timeframe: From the first dose of study drug through Week 156
Intervention | weeks (Median) | |
---|---|---|
Duration of erythroid response (major or minor) | Duration of major erythroid response | |
Lenalidomide | 76.6 | 72.1 |
"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.~A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period." (NCT00812968)
Timeframe: Response was assessed every 12 weeks through Week 156
Intervention | participants (Number) | |
---|---|---|
Major response | Minor response | |
Lenalidomide | 1 | 5 |
"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.~A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.~Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days." (NCT00812968)
Timeframe: Response was assessed every 28 days through Week 156.
Intervention | participants (Number) | |
---|---|---|
Erythroid responders (major or minor) | Major erythroid responders | |
Lenalidomide | 11 | 11 |
"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.~A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period." (NCT00812968)
Timeframe: Response was assessed every 28 days through Week 156
Intervention | participants (Number) | |
---|---|---|
Major response | Minor response | |
Lenalidomide | 1 | 0 |
"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~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 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death." (NCT00812968)
Timeframe: After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).
Intervention | participants (Number) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Any adverse event (AE) | AE related to study drug | Grade 3 or 4 AE | Grade 3 or 4 AE related to study drug | Serious AE (SAE) | SAE related to study drug | AE leading to discontinuation of study drug | Related AE leading to discontinuation | AE leading to a dose reduction or interruption | Related AE leading to dose reduction/interruption | Deaths | |
Lenalidomide | 11 | 11 | 11 | 11 | 3 | 1 | 0 | 0 | 10 | 9 | 0 |
Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).
Intervention | Percentage of myeloblasts (Median) | ||
---|---|---|---|
Baseline (N=11) | End of Cycle 3 (N=10) | End of Cycle 6 (N=10) | |
Lenalidomide | 3.77 | 1.47 | 1.79 |
Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).
Intervention | Percentage of promyelocytes (Median) | ||
---|---|---|---|
Baseline (N=11) | End of Cycle 3 (N=10) | End of Cycle 6 (N=10) | |
Lenalidomide | 5 | 5 | 5 |
Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response. (NCT00812968)
Timeframe: From the first dose of study drug through Week 156
Intervention | weeks (Median) | |
---|---|---|
Time to erythroid response (major or minor) | Time to major erythroid response | |
Lenalidomide | 2.1 | 6.3 |
Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death. (NCT00352794)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|---|
Lenalidomide + Prednisone | 14 |
Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months. (NCT01029054)
Timeframe: 6 Months
Intervention | mg/m^2 (Number) |
---|---|
Carfilzomib, Lenalidomide w/Dexamethasone | 36 |
"The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.~Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia." (NCT01029054)
Timeframe: 12 Months and 24 Months Post Treatment
Intervention | percentage of patients (Number) | |
---|---|---|
Percentage of Patients Without Progression at 12 m | Percentage of Patients Without Progression at 24 m | |
Carfilzomib, Lenalidomide w/Dexamethasone | 97 | 92 |
"The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.~sCR is defined as:~Negative immunofixation on the serum and urine and~Disappearance of any soft tissue plasmacytomas and~< 5% plasma cells in bone marrow and~Normal SFLC ratio and~Absence of clonal cells in bone marrow~VGPR is defined as:~Serum and urine M-protein detectable by immunofixation but not on electrophoresis or~≥ 90% reduction in serum M-component with urine M-component < 100 mg per 24 hours~PR is defined as:~≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours~If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required" (NCT01029054)
Timeframe: 4 Months After Treatment Start
Intervention | percentage of patients (Number) | ||
---|---|---|---|
% of patients that achieve at least a sCR | % of patients that achieve at least a VGPR | % of patients that achieve at least a PR | |
Carfilzomib, Lenalidomide w/Dexamethasone | 42 | 81 | 98 |
23 reviews available for thalidomide and Anemia
Article | Year |
---|---|
Novel therapies in low- and high-risk myelodysplastic syndrome.
Topics: Activin Receptors, Type II; Anemia; Antineoplastic Agents; Azacitidine; Bridged Bicyclo Compounds, H | 2019 |
Myelofibrosis: an update on current pharmacotherapy and future directions.
Topics: Age Factors; Androgens; Anemia; Humans; Immunologic Factors; Janus Kinase 2; Mutation; Nitriles; Pri | 2013 |
How we treat lower-risk myelodysplastic syndromes.
Topics: Anemia; Angiogenesis Inhibitors; Antineoplastic Agents; Humans; Lenalidomide; Myelodysplastic Syndro | 2013 |
Lenalidomide: a review of its use in patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndrome associated with 5q chromosome deletion.
Topics: Anemia; Anemia, Macrocytic; Angiogenesis Inhibitors; Chromosome Deletion; Chromosomes, Human, Pair 5 | 2013 |
Does anything work for anaemia in myelofibrosis?
Topics: Androgens; Anemia; Blood Transfusion; Erythropoietin; Hematinics; Humans; Immunosuppressive Agents; | 2014 |
[Supportive care in multiple myeloma for continuing anti-myeloma therapies].
Topics: Anemia; Bone Density Conservation Agents; Bone Diseases, Metabolic; Boronic Acids; Bortezomib; Dipho | 2014 |
[Changes in the prognosis and treatment of Waldenström macroglobulinemia. Literature overview and own experience].
Topics: Adenine; Anemia; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protoc | 2016 |
Characterization, regulation, and targeting of erythroid progenitors in normal and disordered human erythropoiesis.
Topics: Anemia; Animals; Biomarkers; Cell Differentiation; Cell Proliferation; Cell Self Renewal; Erythroid | 2017 |
Lenalidomide use in myelodysplastic syndromes: Insights into the biologic mechanisms and clinical applications.
Topics: Anemia; Antimetabolites, Antineoplastic; Azacitidine; Chromosomes, Human, Pair 5; Disease Progressio | 2017 |
Lenalidomide for treatment of myelodysplastic syndromes: current status and future directions.
Topics: Aged; Anemia; Animals; Apoptosis; Blood Transfusion; Bone Marrow; cdc25 Phosphatases; Cell Nucleus; | 2010 |
Lenalidomide in myelodysplastic syndromes: an erythropoiesis-stimulating agent or more?
Topics: Anemia; Blood Transfusion; Chromosome Deletion; Chromosomes, Human, Pair 5; Clinical Trials as Topic | 2010 |
Current and future management options for myelodysplastic syndromes.
Topics: Adenine Nucleotides; Anemia; Arabinonucleosides; Benzamides; Bone Marrow; Clofarabine; DNA Methylati | 2010 |
Multiple myeloma.
Topics: Anemia; Bone Diseases; Boronic Acids; Bortezomib; Clinical Trials as Topic; Cysteine Proteinase Inhi | 2011 |
Management of the adverse effects of lenalidomide in multiple myeloma.
Topics: Anemia; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillation; | 2011 |
Renal crescentic alpha heavy chain deposition disease: a report of 3 cases and review of the literature.
Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Cuti | 2011 |
ADVANCES IN OBSTETRICS AND GYNAECOLOGY.
Topics: Anemia; Endocrinology; Erythroblastosis, Fetal; Female; Genital Neoplasms, Female; Gynecology; Hormo | 1963 |
Management of anemia associated with myelodysplastic syndrome.
Topics: Anemia; Antilymphocyte Serum; Erythrocyte Transfusion; Hematopoietic Cell Growth Factors; Humans; Im | 2005 |
Strategies for achieving transfusion independence in myelodysplastic syndromes.
Topics: Anemia; Antilymphocyte Serum; Antimetabolites, Antineoplastic; Azacitidine; Decitabine; Drug Costs; | 2007 |
Lenalidomide: targeted anemia therapy for myelodysplastic syndromes.
Topics: Anemia; Antineoplastic Agents; Chromosome Deletion; Chromosomes, Human, Pair 5; Drug Delivery System | 2006 |
Evolving applications of lenalidomide in the management of anemia in myelodysplastic syndromes.
Topics: Algorithms; Anemia; Antineoplastic Agents; Blood Transfusion; Chromosome Deletion; Chromosomes, Huma | 2006 |
[Pathophysiology, diagnosis and treatment of anemia].
Topics: Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Azacitidin | 2008 |
[Development trend in new therapeutic approaches for anemia].
Topics: Anemia; Benzoates; Clinical Trials as Topic; Darbepoetin alfa; Deferasirox; Erythropoietin; Hematini | 2008 |
Prognostic factors and current practice in treatment of myelofibrosis with myeloid metaplasia: an update anno 2000.
Topics: Aged; Anemia; Aneuploidy; Angiogenesis Inhibitors; Bone Marrow Transplantation; Case Management; Com | 2001 |
29 trials available for thalidomide and Anemia
Article | Year |
---|---|
Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Disease-Free Su | 2017 |
Thalidomide plus prednisone with or without danazol therapy in myelofibrosis: a retrospective analysis of incidence and durability of anemia response.
Topics: Adult; Aged; Anemia; Danazol; Female; Humans; Male; Middle Aged; Prednisolone; Primary Myelofibrosis | 2018 |
Modest activity of pomalidomide in patients with myelofibrosis and significant anemia.
Topics: Aged; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Female; Follo | 2013 |
Use of the Functional Assessment of Cancer Therapy--anemia in persons with myeloproliferative neoplasm-associated myelofibrosis and anemia.
Topics: Anemia; Bayes Theorem; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Myeloproliferativ | 2014 |
Phase II study of pomalidomide in combination with prednisone in patients with myelofibrosis and significant anemia.
Topics: Aged; Aged, 80 and over; Anemia; Drug Administration Schedule; Drug Therapy, Combination; Female; Hu | 2014 |
Lenalidomide and dexamethasone for acute light chain-induced renal failure: a phase II study.
Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Anemia; Dexamethasone; Female; Glomerular Filtration R | 2015 |
Lenalidomide is safe and active in Waldenström macroglobulinemia.
Topics: Administration, Oral; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Drug Administration Sc | 2015 |
Lenalidomide with or without erythropoietin in transfusion-dependent erythropoiesis-stimulating agent-refractory lower-risk MDS without 5q deletion.
Topics: Aged; Anemia; Angiogenesis Inhibitors; Blood Transfusion; Chromosome Deletion; Chromosomes, Human, P | 2016 |
VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial.
Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Cyclophosphamide; D | 2016 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherap | 2017 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
Lenalidomide and rituximab in Waldenstrom's macroglobulinemia.
Topics: Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Ant | 2009 |
N9986: a phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia.
Topics: Aged; Aged, 80 and over; Anemia; Dose-Response Relationship, Drug; Fatigue; Female; Humans; Immunosu | 2009 |
Pomalidomide is active in the treatment of anemia associated with myelofibrosis.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Double-Blind Method; Female; Glucocorticoids; Hematinics; Hu | 2009 |
Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality.
Topics: Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Asian People; Chromosome Deletion; Chromosom | 2009 |
Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Drug Therapy, Combination; Enzyme-Lin | 2009 |
A modular Phase I study of lenalidomide and paclitaxel in metastatic castration-resistant prostate cancer following prior taxane therapy.
Topics: Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bridged-Ring Compounds; Combined Modal | 2010 |
Phase1/-2 study of Pomalidomide in myelofibrosis.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Anti-Inflammatory Agents; Female; Humans; Immunosuppressive | 2010 |
Single agent lenalidomide in newly diagnosed multiple myeloma: a retrospective analysis.
Topics: Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Disease-Free Survival; Female; Humans; Lenal | 2010 |
A phase-2 trial of low-dose pomalidomide in myelofibrosis.
Topics: Aged; Aged, 80 and over; Anemia; Basophils; Erythrocyte Transfusion; Female; Humans; Janus Kinase 2; | 2011 |
Circulating levels of MCP-1, sIL-2R, IL-15, and IL-8 predict anemia response to pomalidomide therapy in myelofibrosis.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Chemokine CCL2; Cytokines; Female; Humans; Interleukin-15; I | 2011 |
A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Mod | 2012 |
A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Mod | 2012 |
A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Mod | 2012 |
A phase 1/2 study of carfilzomib in combination with lenalidomide and low-dose dexamethasone as a frontline treatment for multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Mod | 2012 |
Effects of exercise on fatigue, sleep, and performance: a randomized trial.
Topics: Adult; Affect; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Thera | 2012 |
Negligible clinical effects of thalidomide in patients with myelofibrosis with myeloid metaplasia.
Topics: Adult; Aged; Anemia; Blood Transfusion; Bone Marrow; Female; Humans; Leprostatic Agents; Male; Middl | 2002 |
A phase 2 trial of combination low-dose thalidomide and prednisone for the treatment of myelofibrosis with myeloid metaplasia.
Topics: Adrenal Cortex Hormones; Aged; Anemia; Angiogenesis Inhibitors; Antineoplastic Agents, Hormonal; Ant | 2003 |
Low-dose thalidomide ameliorates cytopenias and splenomegaly in myelofibrosis with myeloid metaplasia: a phase II trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Female; Humans; Immunosuppressive Agents; Leukop | 2004 |
Combination of erythropoietin and thalidomide for the treatment of anemia in patients with myelodysplastic syndromes.
Topics: Adult; Aged; Anemia; Drug Therapy, Combination; Erythropoietin; Female; Humans; Male; Middle Aged; M | 2006 |
Lenalidomide therapy in myelofibrosis with myeloid metaplasia.
Topics: Administration, Oral; Adult; Aged; Anemia; Anemia, Myelophthisic; Female; Hemoglobins; Humans; Janus | 2006 |
The role of thalidomide in the treatment of refractory chronic graft-versus-host disease following bone marrow transplantation in children.
Topics: Adolescent; Adult; Anemia; Bone Marrow Transplantation; Child; Child, Preschool; Female; Graft vs Ho | 1998 |
Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes.
Topics: Aged; Anemia; Blood Cell Count; Blood Transfusion; Bone Marrow; Female; Hematopoiesis; Hemoglobins; | 2001 |
37 other studies available for thalidomide and Anemia
Article | Year |
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Evolution of severe (transfusion-dependent) anaemia in myelodysplastic syndromes with 5q deletion is characterized by a macrophage-associated failure of the eythropoietic niche.
Topics: Anemia; Animals; Chromosome Aberrations; Chromosome Deletion; Chromosomes, Human, Pair 5; Humans; Le | 2022 |
Ruxolitinib combined with prednisone, thalidomide and danazol in patients with myelofibrosis: Results of a pilot study.
Topics: Anemia; Danazol; Hemoglobins; Humans; Myeloproliferative Disorders; Nitriles; Pilot Projects; Predni | 2022 |
Multiagent therapy with pomalidomide, bortezomib, doxorubicin, dexamethasone, and daratumumab ("Pom-PAD-Dara") in relapsed/refractory multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy | 2020 |
Retrospective Analysis of the Clinical Use and Benefit of Lenalidomide and Thalidomide in Myelofibrosis.
Topics: Aged; Anemia; Drug Therapy, Combination; Female; Humans; Lenalidomide; Male; Primary Myelofibrosis; | 2020 |
Outcome of Lower-Risk Patients With Myelodysplastic Syndromes Without 5q Deletion After Failure of Erythropoiesis-Stimulating Agents.
Topics: Aged; Aged, 80 and over; Anemia; Antilymphocyte Serum; Antineoplastic Agents; Arsenic; Azacitidine; | 2017 |
Multiple myeloma masquerading as diabetic macular oedema.
Topics: Anemia; Antineoplastic Combined Chemotherapy Protocols; Biopsy, Large-Core Needle; Bone Marrow; Cycl | 2018 |
Selection of patients with myelodysplastic syndromes from a large electronic medical records database and a study of the use of disease-modifying therapy in the United States.
Topics: Aged; Aged, 80 and over; Anemia; Azacitidine; Databases, Factual; Decitabine; Electronic Health Reco | 2018 |
Experience with lenalidomide in an Austrian non-study population with advanced myelofibrosis.
Topics: Aged; Aged, 80 and over; Anemia; Austria; Dose-Response Relationship, Drug; Female; Humans; Immunolo | 2013 |
Struggling with myelofibrosis-associated anemia.
Topics: Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Mal | 2013 |
Myeloma kidney: the importance of assessing the response by monitoring free light chains in serum.
Topics: Acute Kidney Injury; Anemia; Biopsy; Boronic Acids; Bortezomib; Dexamethasone; Drug Monitoring; Drug | 2013 |
Transfusion dependence development and disease evolution in patients with MDS and del(5q) and without transfusion needs at diagnosis.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Biomarkers, Tumor; Blood Transfusion; | 2014 |
Hematologic response and stabilization of renal function in a patient with light chain deposition disease after lenalidomide treatment: a novel therapeutic approach?
Topics: Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Dexamethasone; Fatig | 2014 |
Report of 6 cases of large granular lymphocytic leukemia and plasma cell dyscrasia.
Topics: Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Proto | 2014 |
[Comparison of low-dose thalidomide and prednisone combined with or without danazol for the treatment of primary myelofibrosis-associated anemia].
Topics: Adult; Aged; Anemia; Danazol; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Mi | 2014 |
Transiently Pink-Tinged Serum in a Patient With Multiple Myeloma and Anemia Undergoing Lenalidomide Treatment.
Topics: Anemia; Antineoplastic Agents; Female; Hemolysis; Humans; Lenalidomide; Middle Aged; Multiple Myelom | 2015 |
[Long- term outcome of thalidomide and cyclosporine in patients with IPSS low/intermediate- 1 myelodysplastic syndromes].
Topics: Adaptor Proteins, Signal Transducing; Anemia; Blood Platelets; Blood Transfusion; Bone Marrow; China | 2015 |
Bone marrow infiltration by multiple myeloma causes anemia by reversible disruption of erythropoiesis.
Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Biomarkers; Bone Marrow; Bortez | 2016 |
Therapeutic failure with thalidomide in patients with recurrent intestinal bleeding due to angiodysplasias.
Topics: Aged; Anemia; Angiodysplasia; Gastrointestinal Hemorrhage; Humans; Immunosuppressive Agents; Male; M | 2016 |
Anaemia with inflammation responding to lenalidomide.
Topics: Aged; Anemia; Female; Humans; Immunologic Factors; Inflammation; Lenalidomide; Thalidomide; Treatmen | 2016 |
Responses to pomalidomide and placebo in myelofibrosis-related anaemia.
Topics: Anemia; Humans; Immunologic Factors; Primary Myelofibrosis; Thalidomide | 2017 |
Outcome of patients treated for myelodysplastic syndromes without deletion 5q after failure of lenalidomide therapy.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Angiogenesis Inhibitors; Chromosome Deletion; Chromosomes, H | 2017 |
The costs of drugs used to treat myelodysplastic syndromes following National Comprehensive Cancer Network Guidelines.
Topics: Anemia; Antineoplastic Agents; Azacitidine; Cost of Illness; Costs and Cost Analysis; Darbepoetin al | 2008 |
Dyskeratosis congenita: a case report.
Topics: Anemia; Child; Diagnosis, Differential; Dyskeratosis Congenita; Humans; Immunologic Factors; Lichen | 2009 |
Management of myelodysplastic syndromes in the geriatric patient.
Topics: Aged; Anemia; Antineoplastic Agents; Azacitidine; Decitabine; Erythrocyte Transfusion; Erythropoieti | 2009 |
Efficacy of the association of lenalidomide to erythropoiesis-stimulating agents in del (5q) MDS patients refractory to single-agent lenalidomide.
Topics: Aged; Anemia; Antineoplastic Agents; Cell Survival; Drug Therapy, Combination; Female; Hematinics; H | 2010 |
Treatment considerations for primary myelofibrosis.
Topics: Anemia; Angiogenesis Inhibitors; Antineoplastic Agents; Humans; Lenalidomide; Leukemia, Myeloid, Chr | 2010 |
Very short-term lenalidomide treatment associated with durable resolution of anemia in a patient with myelodysplastic syndrome with chromosome 5q deletion.
Topics: Aged; Anemia; Chromosome Deletion; Chromosomes, Human, Pair 5; Female; Humans; Lenalidomide; Myelody | 2012 |
Thalidomide treatment in cirrhotic patients with severe anemia secondary to vascular malformations.
Topics: Aged; Anemia; Angiogenesis Inhibitors; Female; Gastrointestinal Hemorrhage; Hepatic Encephalopathy; | 2012 |
Lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone for heavily pretreated relapsed or refractory multiple myeloma.
Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Dexa | 2013 |
Thalidomide in myelofibrosis with myeloid metaplasia: a pooled-analysis of individual patient data from five studies.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Clinical Trials, Phase II as Topic; Female; Hemoglobins; Hum | 2002 |
Signet ring-like light chain myeloma with systemic spread.
Topics: Anemia; Antineoplastic Agents; Bone Marrow Examination; Combined Modality Therapy; Diagnostic Errors | 2003 |
Alleviation of systemic manifestations of multicentric Castleman's disease by thalidomide.
Topics: Adult; Anemia; Antibodies, Viral; Axilla; Biopsy; Castleman Disease; Cytokines; Female; Herpesvirus | 2003 |
[SIMILARITIES AND PECULIARITIES OF FANCONI'S ANEMIA AND THALIDOMIDE EMBRYOPATHY].
Topics: Abnormalities, Multiple; Anemia; Anemia, Aplastic; Diagnosis, Differential; Ectromelia; Fanconi Anem | 1964 |
Lenalidomide (Revlimid) for anemia of myelodysplastic syndrome.
Topics: Anemia; Chromosome Deletion; Chromosomes, Human, Pair 5; Contraindications; Female; Humans; Lenalido | 2006 |
Lenalidomide: from bench to bedside (part 1).
Topics: Anemia; Antineoplastic Agents; Humans; Lenalidomide; Myelodysplastic Syndromes; Thalidomide | 2006 |
Practical considerations in the use of lenalidomide therapy for myelodysplastic syndromes.
Topics: Anemia; Antineoplastic Agents; Chromosome Deletion; Chromosomes, Human, Pair 5; Dexamethasone; Drug | 2006 |
Decreases in mean hemoglobin and serum albumin values in erythema nodosum leprosum and lepromatous leprosy.
Topics: Anemia; Dapsone; Erythema Nodosum; Hemoglobins; Humans; Leprostatic Agents; Leprosy, Lepromatous; Pr | 2001 |