Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial.

Also, the route of administration (intravenous vs. subcutaneous) and the side effects resulting from induction therapy, pre-transplant high-dose chemotherapy, ASCT, and other medications (i.e., thalidomide) in the control arm during consolidation/maintenance might have confounded the results. — all in France; Centre Hospitalier Universitaire, Lausanne, Switzerland (S.L. In January 2011, an increased incidence of second primary cancers was observed in the lenalidomide group. The keywords used for the literature search were “myeloma,” “bortezomib,” and “consolidation OR maintenance OR continuous therapy.” We also searched for abstracts presented at the Efficacy outcomes included PFS and/or OS. and Institut Curie (C.M. Stadtmauer, E. A. et al. All authors had full access to the primary data and results of the final analysis, made the decision to submit the manuscript for publication, and vouch for the accuracy and completeness of the data and analyses. The primary end point was progression-free survival.Lenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001).

As of October 2011, an increased incidence of second primary cancers was observed in the lenalidomide group (This phase 3 study documents that maintenance therapy with lenalidomide after transplantation is associated with significant improvement in outcomes for patients with newly diagnosed myeloma. You can also search for this author in Higgins, J. P. & Thompson, S. G. Quantifying heterogeneity in a meta-analysis. Introduction After autologous stem cell transplantation (ASCT), patients with multiple myeloma (MM) have their tumor burden reassessed approximately 100 days later, 1,2 the results of which classify their clinical response based on the International Myeloma Working Group (IMWG) criteria.

Bortezomib induction and maintenance treatment improves survival in patients with newly diagnosed multiple myeloma: extended follow-up of the HOVON-65/GMMG-HD4 Trial. ), Centre Hospitalier Brabois, Nancy (C.H. Attal, M. et al. Response, progression-free survival, overall survival, and safety data were analyzed with a data cutoff date of July 7, 2010 (date of study unblinding).

Despite the limitations of this analysis, we have some suggestion of the benefit of bortezomib-based maintenance therapy, particularly in high-risk patients.

Sonneveld, P. et al. The independent data and safety monitoring committee recommended stopping lenalidomide maintenance therapy and continuing follow-up each month to determine survival and detect second primary cancers. ), Hôpital St.-Antoine (L.G.)

J Clin … Most myeloma patients will receive maintenance therapy as part of their treatment plan. Patients were recruited from July 2006 through August 2008. Sep 1, 2020 Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study.

Secondary end points included the response rate, event-free survival, and overall survival.Toxic effects were graded according to the World Health Organization toxicity criteria, version 3.0.

), Centre Hospitalier Le Bocage, Dijon (D.C.), Hôtel Dieu, Nantes (P.M., H.A.-L., J.-L.H. We performed a meta-analysis to evaluate the impact of bortezomib-based consolidation and maintenance therapy on survival outcomes and adverse events. Lenalidomide maintenance therapy improved the rate of a complete or very good partial response, as compared with placebo (P=0.009) (Panel A shows progression-free survival, with median rates of 41 months in the lenalidomide group as compared with 23 months in the placebo group (hazard ratio, 0.50; P<0.001).

At 3 years after randomization, overall survival was similar in the two groups (hazard ratio, 1.25; P=0.29).Tap into groundbreaking research and clinically relevant insights ), Hôpital Haut-Lévêque, Bordeaux Pessac (G.M.

Our meta-analysis showed a trend of increased risk of grade ≥ 3 neurologic adverse events with bortezomib-based consolidation/maintenance. The study was approved by the institutional ethics committee of the coordinating center (Centre Hospitalier Universitaire Purpan, Toulouse, France). Given that different patient groups may respond differently to a specific regimen, we believe a risk-adapted approach should be used in future studies to tailor consolidation and maintenance therapy based on disease risks, regimens used in induction therapy, and minimal residual disease status.Kazandjian, D. Multiple myeloma epidemiology and survival: a unique malignancy. For many years, interferon with or without glucocorticoids was used,Lenalidomide (Revlimid, Celgene), a derivative of thalidomide, is less toxic and more potent than the parent drug.Patients were eligible if they were less than 65 years of age and presented with multiple myeloma that had not progressed in the interval between first-line autologous stem-cell transplantation (either one or two procedures), performed within the previous 6 months, and randomization. & Mazumdar, M. Operating characteristics of a rank correlation test for publication bias. We identified seven RCTs (published in six articles)Maintenance therapy refers to a course of low-dose chemotherapy over a long period of time for patients with MM after induction therapy ± ASCT.

The pooled HRs ranged from 0.75 to 0.80 for PFS and from 0.90 to 1.02 for OS in the consolidation setting.