Relapsed/refractory patients

ASH 2017 | Phase III study of bortezomib (VCD) versus lenalidomide (RCD) combos in first relapse

The MM Hub is pleased to share research findings from the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.  On Monday 11 December, the evening oral abstract session took place for Session 653. Myeloma: Therapy, excluding Transplantation Studies in Relapsed and Refractory Multiple Myeloma.  In this session, Dr. Vittorio Montefusco of Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy presented data based on Abstract 836: Bortezomib, Cyclophosphamide and Dexamethasone Versus Lenalidomide, Cyclophosphamide and Dexamethasone in Multiple Myeloma Patients at First Relapse: Final Results of a Phase III Study. The MM summary is based on updated data presented at the ASH session and therefore may supersede the data in the pre-published abstract.

The goal of the study was to compare bortezomib and lenalidomide in a three-drug regimen with dexamethasone and cyclophosphamide at first relapse in Multiple Myeloma (MM) patients. The study design was a phase III, prospective, multicenter, open-label trial.  The primary endpoint was very good partial response (VGPR) at 6 weeks after the 9th cycle of therapy. 

Key Findings:
  • Total patients (pts) (n = 155)
    • Bortezomib, cyclophosphamide, dexamethasone (VCD) = 76 pts 
      • Lenalidomide, cyclophosphamide, dexamethasone (RCD) = 79 pts 
  • Median age = 65 years for both groups
  • Median creatine clearance (Clcr): VCD = 72.4 mL/min; RCD = 84.8 mL/min
  • Median PFS after 1st line therapy: VCD = 3 years vs RCD = 2.9 years
  • ≥ VGPR at 6 weeks after 9th cycle: VCD = 12 pts vs RCD = 14 pts (p = NS)
  • PFS at 24 months: VCD 34% vs RCD 40% (p = NS)
  • Overall response rate (ORR): VCD = 65% vs RCD = 82%
  • In subgroup analyses, PFS and OS not influenced by:
    • First-line bortezomib therapy
    • ISS at diagnosis
    • PFS after first-line therapy
  • Adverse events
    • Grade 3 neutropenia RCD = 14pts vs VCD = 1 pt
    • Grade 2 neuropathy RCD = 0 pts vs VCD = 4 pts
    • Grade 3 thrombosis RCD = 3 pts vs VCD = 0 pts

In this first head-to-head study comparing lenalidomide and bortezomib combination therapies in first relapse MM patients, both regimens had comparable efficacy results. Toxicity profiles for the regimens are varied, such that therapy selection should be guided by patient co-morbidities and avoidance of major toxicities.

References
  1. Montefusco V. et al. Bortezomib/Cyclophosphamide/Dexamethasone Versus Lenalidomide/Cyclophosphamide/Dexamethasone in Multiple Myeloma Patients at First Relapse: Final Results of a Phase III Study. Abstract #836. 59th ASH Annual Meeting and Exposition 2017, Atlanta, GA.
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