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.
- 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.
- 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.
Banner University Medical Center - Tucson
VA Central California Fresno Medical Center
Contact: Laura B Peters
UCLA / Jonsson Comprehensive Cancer Center
Contact: Vlad Kustanovich
Mayo Clinic in Florida
University of Maryland / Greenebaum Cancer Center
Contact: Meghan Nichole Luhowy
Wayne State University / Karmanos Cancer Institute
Mayo Clinic in Rochester
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Case Comprehensive Cancer Center
University of Pittsburgh Cancer Institute (UPCI)
M D Anderson Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Trial Phase Phase III
Trial Type Treatment
- Primary ID M13-494
- Secondary IDs NCI-2018-01380, 2017-003838-88
- Clinicaltrials.gov ID NCT03539744