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

Study Identifier
M16-085
CT.gov Identifier
NCT03567616
EudraCT Identifier
2017-004232-11
EUCTIS ID
Not available
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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, Spanish
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
    • Study Drug
  • Venetoclax
  • Pomalidomide
  • Dexamethasone
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    John B. Amos Cancer Center - C /ID# 202055
    Columbus, Georgia, United States, 31904
    Status
    Not applicable
    Location
    University of Kansas Cancer Center /ID# 201292
    Fairway, Kansas, United States, 66205-2528
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 201287
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
    Location
    Duke University Hospital /ID# 200805
    Durham, North Carolina, United States, 27710
    Status
    Not applicable
    Location
    Ohio State Cancer Center /ID# 202443
    Columbus, Ohio, United States, 43210
    Status
    Not applicable
    Location
    Hospital Universitario Germans Trias i Pujol /ID# 200959
    Badalona, Barcelona, Spain, 08916
    Status
    Not applicable
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