Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: a randomized controlled trial.

  title={Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: a randomized controlled trial.},
  author={Antonio Palumbo and Sara Bringhen and Davide Rossi and Maide Cavalli and Alessandra Larocca and Roberto Ria and Massimo Offidani and Francesca Patriarca and Chiara Nozzoli and Tommasina Guglielmelli and Giulia Benevolo and Vincenzo Callea and Luca Baldini and Fortunato Morabito and Mariella Grasso and Giovanna Leonardi and Manuela Rizzo and Antonietta Pia Falcone and Daniela Gottardi and Vittorio Montefusco and Pellegrino Musto and Maria Teresa Petrucci and Giovannino Ciccone and Mario Boccadoro},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  volume={28 34},
  • A. PalumboS. Bringhen M. Boccadoro
  • Published 1 December 2010
  • Medicine, Biology
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
PURPOSE The combination of bortezomib-melphalan-prednisone (VMP) is a new standard of care for newly diagnosed multiple myeloma. This phase III study examined the efficacy of the four-drug combination of bortezomib-melphalan-prednisone-thalidomide (VMPT) followed by maintenance with bortezomib-thalidomide (VMPT-VT) compared with VMP treatment alone in untreated multiple myeloma patients who are ineligible for autologous stem-cell transplantation. PATIENTS AND METHODS A total of 511 patients… 

Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib-melphalan-prednisone (VMP) in untreated multiple myeloma patients with renal impairment.

VMPT-VT was superior to VMP for cases with normal renal function and moderate RI, whereas VMPT -VT failed to outperform VMP in patients with severe RI, although the relatively low number of cases analyzed preclude drawing definitive conclusions.

First-line therapy with either bortezomib-melphalan-prednisone or lenalidomide-dexamethasone followed by lenalidomide for transplant-ineligible multiple myeloma patients: a pooled analysis of two randomized trials

In this non-randomized analysis, VMP and Rd-R were equally effective in younger (≤75 years), standard-risk patients, while older ones (>75 years) benefited more from Rd- R and in high- risk patients, V MP improved progression-free survival and overall survival irrespective of age.

Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial.

These maintenance regimens result in a significant increase in CR rate, remarkably long PFS, and acceptable toxicity profile, and this approach was not able to overcome the adverse prognosis of cytogenetic abnormalities.

Bortezomib, melphalan, prednisone (VMP) versus melphalan, prednisone, thalidomide (MPT) in elderly newly diagnosed multiple myeloma patients: A retrospective case‐matched study

Multivariate analysis confirmed that VMP was an independent predictor of longer PFS and OS in patients who received VMP in comparison with those treated with MPT.

Sequential therapy of four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma

Se sequential therapy with VMP followed by Rd is effective and mostly feasible for transplant-ineligible NDMM.

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

It is suggested that the less-intensive PETHEMA/GEM05 VMP regimen plus maintenance may improve PFS and TTP, but not OS, compared with the VISTA V MP regimen.

Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation: the MMVAR/IFM 2005-04 Randomized Phase III Trial from the Chronic Leukemia

VTD was more effective than TD in the treatment of patients with MM with progressive or relapsing disease post-ASCT but was associated with a higher incidence of grade 3 neurotoxicity.

Bortezomib in combination with thalidomide or lenalidomide or doxorubicin regimens for the treatment of multiple myeloma: a meta-analysis of 14 randomized controlled trials

The results indicated that the VT regimen had an improved benefit in complete remission (CR) and overall response rate (ORR), but not in progression-free survival (PFS), overall survival (OS) and major grade III/IV adverse events such as peripheral neuropathy, thrombotic events and infection.

Bortezomib, melphalan, and prednisone in elderly relapsed/refractory multiple myeloma patients: update of multicenter, open-label Phase 1/2 study

The ‘Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone’ (VISTA) trial identified VMP as one of the new standards of care for patients with newly diagnosed multiple myeloma (MM) not eligible for transplantation with lower toxicity and comparable efficacy.



A Prospective, Multicenter, Randomized, Trial of Bortezomib/Melphalan/Prednisone (VMP) Versus Bortezomib/Thalidomide/Prednisone (VTP) as Induction Therapy Followed by Maintenance Treatment with Bortezomib/Thalidomide (VT) Versus Bortezomib/Prednisone (VP) in Elderly Untreated Patients with Multiple

The intensity of both schedules of induction was reduced as compared with the VISTA regimen but supplemented with maintenance therapy, and maintenance therapy was able to increase the CR rate from 25% (mean obtained after induction therapy) up to 42%, with no significant differences between VT and VP arms.

Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma.

Initial results showed that VMPT is an effective salvage therapy with a very high proportion of responses and the incidence of neurotoxicities was unexpectedly low.

Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure.

  • A. SpencerH. Prince N. Kennedy
  • Medicine, Biology
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2009
Consolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high-dose therapy supported ASCT in patients with newly diagnosed multiple myeloma.

Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma.

Bortezomib plus melphalan-prednisone alone in patients with newly diagnosed myeloma who were ineligible for high-dose therapy was superior to melphAlan-predisonsone alone.

Melphalan + Prednisone Versus Melphalan + Prednisone + Thalidomide in Induction Therapy for Multiple Myeloma in Elderly Patients: Final Analysis of the Dutch Cooperative Group HOVON 49 Study

In this randomised phase III study in elderly patients with multiple myeloma the addition of Thalidomide to MP resulted in a significant better RR and the quality of the responses (number of VGPR and PFS after CR/PR) and time to response were in favour of MPT.

Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial.

  • C. HulinT. Facon P. Moreau
  • Medicine
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2009
This trial confirms the superiority of the combination melphalan and prednisone plus thalidomide over melphAlan andprednisone alone for prolonging survival in very elderly patients with newly diagnosed myeloma.

A Phase III Study to Determine the Efficacy and Safety of Lenalidomide in Combination with Melphalan and Prednisone (MPR) in Elderly Patients with Newly Diagnosed Multiple Myeloma

PFS was significantly improved in patients who received MPR followed by lenalidomide maintenance compared with those who received MP followed by placebo maintenance, demonstrating a highly statistically significant improvement in PFS for patients treated with MPR compared with MP as first-line treatment for MM patients.

Thalidomide and hematopoietic-cell transplantation for multiple myeloma.

When incorporated into high-dose therapy for myeloma, thalidomide increased the frequency of complete responses and extended event-free survival at the expense of added adverse effects without improving overall survival.