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A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Trial Status: administratively complete
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03567616.
Locations matching your search criteria
United States
Kansas
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Temporarily closed to accrual
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Temporarily closed to accrual
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
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
