drugset / Trial / NCT03567616

A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

NCT03567616

Phase 2 Terminated 8 enrolled AbbVie Celgene Corporation · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.

Timeline

Start
2018-10-18
Primary completion
2020-06-18
Completion
2020-06-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 400 mg Oral
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral
Background Pomalidomide Other / unclassified 4 mg Oral

Indications