Multiple Myeloma Clinical Trial
A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
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.
Full Description
Following communication of the results of the primary progression-free survival (PFS) analysis from the Phase 3 BELLINI study (Study M14-031; NCT02755597), the company-sponsored MM studies were placed on partial clinical hold (PCH) in March 2019 by the United States (US) Food and Drug Administration and enrollment was halted. The sponsor did not pursue release of the PCH for this study; therefore, enrollment was not re-opened. In accordance with the terms of the PCH, participants who were deriving clinical benefit were allowed to continue to receive treatment. One participant was still active in Part 1 of the study when the sponsor decided not to pursue release of the PCH (in January 2020) and, therefore, continued to receive treatment and have regular assessments until disease progression. The study was discontinued when the last participant completed study treatment. No participants were enrolled in Part 2 of the study.
Eligibility 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
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There are 11 Locations for this study
Columbus Georgia, 31904, United States
Fairway Kansas, 66205, United States
Saint Louis Missouri, 63110, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Badalona Barcelona, 08916, Spain
Barcelona , 08035, Spain
Salamanca , 37007, Spain
Leicester England, LE1 5, United Kingdom
Norwich Norfolk, NR4 7, United Kingdom
Birmingham , B15 2, United Kingdom
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