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.
Phase 3 – large-scale trial before approval
Conditions:
Multiple Myeloma
Sponsor: AbbVie
trial.available_in:
БГ
Overview
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
Who can participate
Inclusion Criteria:
* Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (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 t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
* An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* 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.
Locations
19
Australia (1)
Liverpool Hospital /ID# 202431
Liverpool , New South Wales
Canada (1)
Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846
Calgary , Alberta
China (1)
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014