A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Trial Status: Complete
This study is 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 have received at least 1 prior line of therapy. The study will consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants will be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.
- 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.
- 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
University of Kansas Cancer Center
University of Kansas Cancer Center-Overland Park
University of Kansas Hospital-Westwood Cancer Center
Siteman Cancer Center at Washington University
Duke University Medical Center
Ohio State University Comprehensive Cancer Center
Trial Phase Phase II
Trial Type Treatment
- Primary ID M16-085
- Secondary IDs NCI-2018-01734, 2017-004232-11
- Clinicaltrials.gov ID NCT03567616