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

Status: Active

Description

A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma. Subjects randomized to Arm 2 (PomDex) may elect, if eligible, to receive VenDex therapy after documented disease progression per International Myeloma Working Group (IMWG) criteria.

Eligibility Criteria

Inclusion Criteria

  • Documented diagnosis of multiple myeloma (MM) based on standard IMWG criteria.
  • Measurable disease at screening as defined per protocol.
  • Has received at least 2 prior lines of therapy as described in the protocol.
  • Has had documented disease progression on or within 60 days after completion of the last therapy.
  • Has received at least 2 consecutive cycles of lenalidomide and be refractory to lenalidomide, as defined per protocol.
  • Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
  • Has MM positive for t(11;14).
  • An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
  • - Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.

Exclusion Criteria

  • History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
  • History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
  • Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
  • Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
  • Known meningeal involvement of MM.
  • Concurrent conditions as listed in the protocol.

Locations & Contacts

California

Fresno
VA Central California Fresno Medical Center
Status: Approved
Contact: Margaret Lynne Chase
Phone: 559-225-6100ext4154
Email: Margaret.Chase2@va.gov
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: Vlad Kustanovich
Phone: 310-206-5755
Email: VKustanovich@mednet.ucla.edu

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: In review
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M13-494
Secondary IDs NCI-2018-01380
Clinicaltrials.gov ID NCT03539744