Sequential vs alternating administration of VMP and Rd in elderly patients with newly diagnosed MM.

Abstract

Bortezomib plus melphalan and prednisone (VMP) and lenalidomide plus low-dose dexamethasone (Rd) are 2 standards of care for elderly untreated multiple myeloma (MM) patients. We planned to use VMP and Rd for 18 cycles in a sequential or alternating scheme. Patients (233) with untreated MM, >65 years, were randomized to receive 9 cycles of VMP followed by 9 cycles of Rd (sequential scheme; n = 118) vs 1 cycle of VMP followed by 1 cycle of Rd, and so on, up to 18 cycles (alternating scheme; n = 115). VMP consisted of one 6-week cycle of bortezomib using a biweekly schedule, followed by eight 5-week cycles of once-weekly VMP. Rd included nine 4-week cycles of Rd. The primary end points were 18-month progression free survival (PFS) and safety profile of both schemes. The 18-month PFS was 74% and 80% in the sequential and alternating arms, respectively (P = .21). The sequential and alternating groups exhibited similar hematologic and nonhematologic toxicity. Both arms yielded similar complete response rate (42% and 40%), median PFS (32 months vs 34 months, P = .65), and 3-year overall survival (72% vs 74%, P = .63). The benefit of both schemes was remarkable in patients aged 65 to 75 years. In addition, achieving complete and immunophenotypic response was associated with better outcome. The present approach, based on VMP and Rd, is associated with high efficacy and acceptable toxicity profile with no differences between the sequential and alternating regimens. This trial was registered at www.clinicaltrials.gov as #NCT00443235.

DOI: 10.1182/blood-2015-08-666537

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@article{Mateos2016SequentialVA, title={Sequential vs alternating administration of VMP and Rd in elderly patients with newly diagnosed MM.}, author={Mar{\'i}a Victoria Mateos and Joaqu{\'i}n Mart{\'i}nez-L{\'o}pez and M . A . Hern{\'a}ndez and Enrique-M Ocio and Laura Rosi{\~n}ol and Rafael J. Mart{\'i}nez and A Teruel and Norma Carmen Guti{\'e}rrez and Mar{\'i}a-Luisa Mart{\'i}n Ramos and Albert Oriol and Joan Bargay and Enrique Bengoechea and Yolanda W. Gonz{\'a}lez and Jaime P{\'e}rez de Oteyza and Mercedes Gironella and Cristina Encinas and J. H. Martin and C. Dominguez Cabrera and Bruno Paiva and Mar{\'i}a-Teresa Cedena and Noem{\'i} Puig and Joan Blad{\'e} and Juan-Jos{\'e} Lahuerta and Jes{\'u}s F San-Miguel}, journal={Blood}, year={2016}, volume={127 4}, pages={420-5} }