Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma
Patients treated with an induction regimen of melphalan, prednisone, and lenalidomide followed by lenalidomide maintenance therapy had longer progression-free survival than those who did not receive maintenance therapy. Melphalan–prednisone (MP) has long been the treatment of choice for patients wit...
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| Published in | The New England journal of medicine Vol. 366; no. 19; pp. 1759 - 1769 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
10.05.2012
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| Online Access | Get full text |
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| Abstract | Patients treated with an induction regimen of melphalan, prednisone, and lenalidomide followed by lenalidomide maintenance therapy had longer progression-free survival than those who did not receive maintenance therapy.
Melphalan–prednisone (MP) has long been the treatment of choice for patients with multiple myeloma who are older than 65 years of age.
1
The introduction of new agents in the past few years has substantially changed the treatment of multiple myeloma. MP plus either thalidomide or bortezomib is reported to improve progression-free survival and overall survival, as compared with MP alone,
2
,
3
and these combinations are now considered the new standards of care for elderly patients with newly diagnosed multiple myeloma who are ineligible for stem-cell transplantation.
1
Lenalidomide in combination with dexamethasone is effective in relapsed or refractory multiple myeloma
4
– . . . |
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| AbstractList | Lenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This double-blind, multicenter, randomized study compared melphalan-prednisone-lenalidomide induction followed by lenalidomide maintenance (MPR-R) with melphalan-prednisone-lenalidomide (MPR) or melphalan-prednisone (MP) followed by placebo in patients 65 years of age or older with newly diagnosed multiple myeloma.
We randomly assigned patients who were ineligible for transplantation to receive MPR-R (nine 4-week cycles of MPR followed by lenalidomide maintenance therapy until a relapse or disease progression occurred [152 patients]) or to receive MPR (153 patients) or MP (154 patients) without maintenance therapy. The primary end point was progression-free survival.
The median follow-up period was 30 months. The median progression-free survival was significantly longer with MPR-R (31 months) than with MPR (14 months; hazard ratio, 0.49; P<0.001) or MP (13 months; hazard ratio, 0.40; P<0.001). Response rates were superior with MPR-R and MPR (77% and 68%, respectively, vs. 50% with MP; P<0.001 and P=0.002, respectively, for the comparison with MP). The progression-free survival benefit associated with MPR-R was noted in patients 65 to 75 years of age but not in those older than 75 years of age (P=0.001 for treatment-by-age interaction). After induction therapy, a landmark analysis showed a 66% reduction in the rate of progression with MPR-R (hazard ratio for the comparison with MPR, 0.34; P<0.001) that was age-independent. During induction therapy, the most frequent adverse events were hematologic; grade 4 neutropenia was reported in 35%, 32%, and 8% of the patients in the MPR-R, MPR, and MP groups, respectively. The 3-year rate of second primary tumors was 7% with MPR-R, 7% with MPR, and 3% with MP.
MPR-R significantly prolonged progression-free survival in patients with newly diagnosed multiple myeloma who were ineligible for transplantation, with the greatest benefit observed in patients 65 to 75 years of age. (Funded by Celgene; MM-015 ClinicalTrials.gov number, NCT00405756.). BackgroundLenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This double-blind, multicenter, randomized study compared melphalan–prednisone–lenalidomide induction followed by lenalidomide maintenance (MPR-R) with melphalan–prednisone–lenalidomide (MPR) or melphalan–prednisone (MP) followed by placebo in patients 65 years of age or older with newly diagnosed multiple myeloma.MethodsWe randomly assigned patients who were ineligible for transplantation to receive MPR-R (nine 4-week cycles of MPR followed by lenalidomide maintenance therapy until a relapse or disease progression occurred [152 patients]) or to receive MPR (153 patients) or MP (154 patients) without maintenance therapy. The primary end point was progression-free survival.ResultsThe median follow-up period was 30 months. The median progression-free survival was significantly longer with MPR-R (31 months) than with MPR (14 months; hazard ratio, 0.49; P<0.001) or MP (13 months; hazard ratio, 0.40; P<0.001). Response rates were superior with MPR-R and MPR (77% and 68%, respectively, vs. 50% with MP; P<0.001 and P=0.002, respectively, for the comparison with MP). The progression-free survival benefit associated with MPR-R was noted in patients 65 to 75 years of age but not in those older than 75 years of age (P=0.001 for treatment-by-age interaction). After induction therapy, a landmark analysis showed a 66% reduction in the rate of progression with MPR-R (hazard ratio for the comparison with MPR, 0.34; P<0.001) that was age-independent. During induction therapy, the most frequent adverse events were hematologic; grade 4 neutropenia was reported in 35%, 32%, and 8% of the patients in the MPR-R, MPR, and MP groups, respectively. The 3-year rate of second primary tumors was 7% with MPR-R, 7% with MPR, and 3% with MP.ConclusionsMPR-R significantly prolonged progression-free survival in patients with newly diagnosed multiple myeloma who were ineligible for transplantation, with the greatest benefit observed in patients 65 to 75 years of age. (Funded by Celgene; MM-015 ClinicalTrials.gov number, NCT00405756.) Patients treated with an induction regimen of melphalan, prednisone, and lenalidomide followed by lenalidomide maintenance therapy had longer progression-free survival than those who did not receive maintenance therapy. Melphalan–prednisone (MP) has long been the treatment of choice for patients with multiple myeloma who are older than 65 years of age. 1 The introduction of new agents in the past few years has substantially changed the treatment of multiple myeloma. MP plus either thalidomide or bortezomib is reported to improve progression-free survival and overall survival, as compared with MP alone, 2 , 3 and these combinations are now considered the new standards of care for elderly patients with newly diagnosed multiple myeloma who are ineligible for stem-cell transplantation. 1 Lenalidomide in combination with dexamethasone is effective in relapsed or refractory multiple myeloma 4 – . . . |
| Author | Yu, Zhinuan Weisel, Katja Cavo, Michele Plesner, Torben Mei, Jay Spicka, Ivan Delforge, Michel Catalano, John Radke, Joergen Iosava, Genadi Wiktor-Jędrzejczak, Wiesław Yehuda, Dina Ben Bladé, Joan Dimopoulos, Meletios A Kloczko, Janusz Jacques, Christian Palumbo, Antonio Herbein, Lindsay Langer, Christian Beksac, Meral Kropff, Martin Cascavilla, Nicola Gisslinger, Heinz Zodelava, Mamia Corso, Alessandro Petrucci, Maria Teresa Hajek, Roman |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22571200$$D View this record in MEDLINE/PubMed |
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| Copyright | Copyright © 2012 Massachusetts Medical Society. All rights reserved. |
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| Snippet | Patients treated with an induction regimen of melphalan, prednisone, and lenalidomide followed by lenalidomide maintenance therapy had longer progression-free... Lenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This double-blind, multicenter, randomized study compared... BackgroundLenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This double-blind, multicenter, randomized study compared... BACKGROUNDLenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This double-blind, multicenter, randomized study compared... |
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| SubjectTerms | Administration, Oral Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Clinical trials Disease-Free Survival Double-Blind Method Female Follow-Up Studies Humans Immunomodulation Immunotherapy Induction Chemotherapy Induction therapy Kaplan-Meier Estimate Maintenance Chemotherapy Male Melphalan Melphalan - administration & dosage Melphalan - adverse effects Multiple myeloma Multiple Myeloma - drug therapy Multiple Myeloma - mortality Neoplasms, Second Primary - epidemiology Neutropenia Neutropenia - chemically induced Patients Prednisone Prednisone - administration & dosage Prednisone - adverse effects Survival Targeted cancer therapy Thalidomide - administration & dosage Thalidomide - adverse effects Thalidomide - analogs & derivatives Transplantation Transplants & implants Tumors |
| Title | Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma |
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