A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

Official Title

A Phase 3, Multicentre, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors

Summary:

This is a Phase 3, multicentre, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS).
Secondary Outcome:
  • Very Good Partial Response (VGPR) or better response rate.
  • Progression-Free Survival (PFS) in subjects with high B-cell lymphoma 2 (BCL-2) expression.
  • Duration of Response (DOR).
  • Overall survival (OS).
  • Time to disease progression (TTP).
  • Objective Response Rate (ORR).
  • Minimal Residual Disease (MRD) status.
  • Brief Pain Inventory - Short Form [BPI-SF] - Worst Pain
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) - Physical Functioning
  • Patient Reported Outcomes Measurement Information System - (PROMIS)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) - Global Health Status

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society