A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Stopped early · Phase 2
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT03567616
- Run by
- AbbVie
- People needed
- 8
- Starts
- 2018-10-18
- Expected to finish
- 2020-06-18
- Last updated by the study team
- 2021-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- John B. Amos Cancer Center - C /ID# 202055 — Columbus, Georgia, United States
- University of Kansas Cancer Center /ID# 201292 — Fairway, Kansas, United States
- Washington University-School of Medicine /ID# 201287 — St Louis, Missouri, United States
- Duke University Hospital /ID# 200805 — Durham, North Carolina, United States
- Ohio State Cancer Center /ID# 202443 — Columbus, Ohio, United States
- Hospital Universitario Germans Trias i Pujol /ID# 200959 — Badalona, Barcelona, Spain
- Hospital Universitario Vall d'Hebron /ID# 200967 — Barcelona, Spain
- Hospital Clinico Universitario de Salamanca /ID# 200958 — Salamanca, Spain
- Leicester Royal Infirmary /ID# 202238 — Leicester, England, United Kingdom
- Norfolk and Norwich Univ Hosp /ID# 202240 — Norwich, Norfolk, United Kingdom
- Univ Hospitals Birmingham NHS Foundation trust /ID# 203188 — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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