A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants 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)

• Overall Response Rate (ORR)
• Very Good Partial Response or Better Response Rate (VGPR)
• Overall survival (OS)
• Minimal Residual Disease (MRD) Negativity Rate
• Time to Deterioration in Disease Symptoms
• Time to Deterioration in Physical Functioning
• Change from Baseline in PROMIS Fatigue Score
• Change from Baseline in BPI-SF Worst Pain Score
• Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)
• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)
• Duration of response (DOR)
• Time to Disease Progression (TTP)
• Time to Response (TTR)
• Cmax of Venetoclax
• Trough Concentration (Ctrough) of Venetoclax
• Number of Participants With Adverse Events (AEs)

View this trial on ClinicalTrials.gov