Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Long-term outcomes of modified-intensity lenalidomide, bortezomib and dexamethasone (RVD-lite) in transplant-ineligible multiple myeloma: final report of a phase II trial.
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Gustine Joshua N, O'Donnell Elizabeth K, Laubach Jacob P, Yee Andrew J, Huff Carol Ann, Ghobrial Irene M, Burke Jill N, Harrington Cynthia C, Munshi Nikhil C, Anderson Kenneth C, Richardson Paul G, Raje Noopur S
Аннотация
BACKGROUND: We report the long-term survival outcomes of modified-intensity lenalidomide, bortezomib, and dexamethasone (RVD-lite) as frontline treatment for transplant-ineligible multiple myeloma (MM).
METHODS: RVD-lite was evaluated in an investigator-initiated, multicenter phase II trial in transplant-ineligible MM patients. RVD-lite was administered over a 35-day cycle with lenalidomide 15 mg orally on days 1-21; bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, 15, 22; and dexamethasone 20 mg orally on days 1, 2, 8, 9, 15, 16, 22, and 23 in patients aged £75 years and days 1, 8, 15, and 22 in patients aged >75 years for 9 cycles of induction followed by 6 cycles of consolidation (lenalidomide + bortezomib). Lenalidomide maintenance was not mandated.
RESULTS: Fifty patients were enrolled. Median age was 73 years (range 65-91), and 14% of patients had an ECOG performance status of 2. At best response, the ORR and ³VGPR were 90% and 66%, respectively. After median follow-up of 72 months, the median PFS was 42 months (5-year PFS: 40%), and the median OS was 76 months (5-year OS: 63%). ECOG performance status of 2 was associated with inferior PFS and OS. Thirty-three patients (66%) received lenalidomide maintenance. Two patients (4%) discontinued treatment due to toxicity, and there was no treatment-related mortality.
CONCLUSION: RVD-lite is a well-tolerated and highly effective regimen in transplant-ineligible MM with prolonged PFS and OS. This study provides the framework for frailty-adapted triplet and quadruplet regimens in MM patients. This trial was registered at ClinicalTrials.gov (NCT01782963).
METHODS: RVD-lite was evaluated in an investigator-initiated, multicenter phase II trial in transplant-ineligible MM patients. RVD-lite was administered over a 35-day cycle with lenalidomide 15 mg orally on days 1-21; bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, 15, 22; and dexamethasone 20 mg orally on days 1, 2, 8, 9, 15, 16, 22, and 23 in patients aged £75 years and days 1, 8, 15, and 22 in patients aged >75 years for 9 cycles of induction followed by 6 cycles of consolidation (lenalidomide + bortezomib). Lenalidomide maintenance was not mandated.
RESULTS: Fifty patients were enrolled. Median age was 73 years (range 65-91), and 14% of patients had an ECOG performance status of 2. At best response, the ORR and ³VGPR were 90% and 66%, respectively. After median follow-up of 72 months, the median PFS was 42 months (5-year PFS: 40%), and the median OS was 76 months (5-year OS: 63%). ECOG performance status of 2 was associated with inferior PFS and OS. Thirty-three patients (66%) received lenalidomide maintenance. Two patients (4%) discontinued treatment due to toxicity, and there was no treatment-related mortality.
CONCLUSION: RVD-lite is a well-tolerated and highly effective regimen in transplant-ineligible MM with prolonged PFS and OS. This study provides the framework for frailty-adapted triplet and quadruplet regimens in MM patients. This trial was registered at ClinicalTrials.gov (NCT01782963).