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Ann Hematol. 2016 Dec;95(12):2033-2041. Epub 2016 Oct 14.

Outcomes with two different schedules of bortezomib, melphalan, and prednisone (VMP) for previously untreated multiple myeloma: matched pair analysis using long-term follow-up data from the phase 3 VISTA and PETHEMA/GEM05 trials.

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Servicio de Hematología, Hospital Universitario de Salamanca, Instituto Biosanitario de Salamanca (IBSAL), Paseo San Vicente 58-182, Salamanca, 37007, Spain.
Clinical Hematology Service and Oncohematological Clinical Trial Unit of the Institut Català d'Oncologia (ICO), Hospital Germans Trias i Pujol, Institut de Recerca contra la Leucèmia Josep Carreras (IJC), Barcelona, Spain.
Hospital Universitario 12 de Octubre, S de Hematología HUNET-CRIS Unidad Ensayos Tempranos, Madrid, Spain.
Hospital Clínico Universitario de Valencia, Servicio de Hematología, Valencia, Spain.
Hospital de Donostia, Servicio de Hematología, Paseo Dr. Beguiristain 115, 20014, Donostia - San Sebastian (Guipúzcoa), Spain.
Servicio de Hematología, Hospital Clínico Universitario "Lozano Blesa" Zaragoza, Instituto de Investigación Sanitaria (ISS) de Aragón, Zaragoza, Spain.
Servicio de Hematología y Hemoterapia, Hospital General Universitario Morales Meseguer, Murcia, Spain.
Oncology Clinical Research, Millennium Pharmaceuticals, Inc, Cambridge, MA, USA.
Janssen Research & Development, High Wycombe, United Kingdom.
Janssen Research & Development, LLC, Raritan, NJ, USA.
Department of Hematology, Clinica Universidad de Navarra-CIMA-IDSINA, Pamplona, Spain.


Bortezomib-melphalan-prednisone (VMP) is a standard-of-care for previously untreated, transplant-ineligible multiple myeloma (MM). Here, we compared outcomes between VMP regimens in the VISTA trial (9-cycle VMP schedule, including 4 cycles of twice weekly bortezomib) and the PETHEMA/GEM05 trial (less intensive 6-cycle VMP schedule with 1 cycle of twice weekly and 5 cycles of weekly bortezomib, then bortezomib-based maintenance). A total of 113 patient pairs matched by propensity score (estimated using logistic regression and incorporating eight exposure/outcome-related parameters) were included in this retrospective analysis. Median cumulative bortezomib dose was higher in PETHEMA/GEM05 than VISTA (49.6 vs 37.0 mg/m2); median dose intensity was lower (2.0 vs 5.1 mg/m2/month). Median progression-free survival (PFS) and time-to-progression (TTP) were significantly longer in PETHEMA/GEM05 than VISTA (PFS, 30.5 vs 20.0 months, p = 0.0265; TTP, 33.8 vs 24.2 months, p = 0.0049) after a median follow-up of 77.2 and 26.0 months, respectively. Median overall survival (OS) was similar (61.3 vs 61.0 months, p = 0.6528; median follow-up, 77.6 vs 60.1 months). Post-induction complete response rate was lower in PETHEMA/GEM05 than VISTA (19 vs 31 %; p = 0.03318); on-study (including maintenance) rate was similar (30 vs 31 %; p = 0.89437). This analysis suggests that the less-intensive PETHEMA/GEM05 VMP regimen plus maintenance may improve PFS and TTP, but not OS, compared with the VISTA VMP regimen.


NCT00111319, NCT00443235.


Bortezomib; Melphalan; Multiple myeloma; PETHEMA/GEM05; Prednisone; VISTA

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