A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Official Title

A Phase 3, Multicentre, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Summary:

A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS)
Secondary Outcome:
  • Very Good Partial Response or Better Response Rate (VGPR)
  • Overall Response Rate (ORR)
  • Overall survival (OS)
  • Duration of response (DOR)
  • Time to Disease Progression (TTP)
  • Time to Response (TTR)
  • Minimal Residual Disease (MRD) Negativity Rate
  • Cmax of Venetoclax
  • Trough Concentration (Ctrough) of Venetoclax
  • Change from Baseline in PROMIS Fatigue Score.
  • Change from Baseline in BPI-SF Worst Pain Score
  • Change from Baseline in EORTC QLQ-30 Physical Functioning Score
  • Change from Baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score

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