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

Trial Status: Active

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.

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 relapsed/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 central nervous system involvement of MM.
  • Concurrent conditions as listed in the protocol.

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

California

Fresno
VA Central California Fresno Medical Center
Status: ACTIVE
Contact: Laura B Peters
Phone: 559-225-6100ext5610
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Vlad Kustanovich
Phone: 310-206-5755

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Meghan Nichole Luhowy
Phone: 410-328-2243

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: IN_REVIEW

Texas

Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Abbvie

  • Primary ID M13-494
  • Secondary IDs NCI-2018-01380, 2017-003838-88
  • Clinicaltrials.gov ID NCT03539744