A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Venetoclax; Pomalidomide; Dexamethasone
Intervention description: Tablet; oral; Capsule; oral; Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]
Intervention MeSH terms: Dexamethasone; Venetoclax; Pomalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Multiple Myeloma (MM); Relapsed or Refractory (R/R); Venetoclax; Pomalidomide; Dexamethasone

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.
    

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