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
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 subject'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 subjects independent of cytogenetic profile.
  • For Part 2, Arm A: subject must be t(11;14) positive.
  • For Part 2, Arm B: subject 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

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

John B. Amos Cancer Center

Columbus, GA

Aurora Cancer Care (Milwaukee West)

Wauwatosa, WI

Georgia
John B. Amos Cancer Center

Columbus, GA

Kansas
Massachusetts
Missouri
North Carolina
Ohio
Oregon
Wisconsin
Aurora Cancer Care (Milwaukee West)

Wauwatosa, WI

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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