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

• Status: Terminated
• Trial end date: 2020-06-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Celgene
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Pomalidomide; Thalidomide; Venetoclax

Criteria

Inclusion Criteria:

• Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen

• Measurable disease as described in the protocol

• Received at least 1 prior line of therapy as described in the protocol

• Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes:

• Received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen

• Refractory to lenalidomide

• Exposed to a proteasome inhibitor (PI) alone or in combination with another agent

• Had a response of partial response (PR) or better to prior therapy based on the investigator's determination of response as defined by International Myeloma Working Group (IMWG) criteria

• Has t(11;14) status as described in the protocol and meets the following criteria:

• For Part 1: MM participants independent of cytogenetic profile

• For Part 2, Arm A: participant must be t(11;14) positive

• For Part 2, Arm B: participant must be t(11;14) negative

• An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Adequate kidney, liver and hematologic laboratory values

Exclusion Criteria:

• Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide

• Known sensitivity to any IMiDs

• Allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease

• Autologous stem cell transplant within 12 weeks before the first dose of study drug

• Known meningeal involvement of MM