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

Overview

This study is designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in subjects with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 1 prior line of therapy. The study will consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the subjects will be divided into 2 cohorts, subjects positive for t(11;14) translocation and subjects negative for t(11;14) translocation.

SparkCures ID 957
Trial Phase Phase 2
Enrollment 60 Patients
Treatments
Trial Sponsors
  • AbbVie
Trial Collaborators
  • Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb
NCT Identifier

NCT03567616

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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