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.

Purpose

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.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 VenDex 		Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
  • Drug: Dexamethasone
    oral, locally available form
  • Drug: Venetoclax
    tablet; oral
    Other names:
    • ABT-199
    • GDC-0199
Active Comparator
Arm 2 PomDex 		Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
  • Drug: Pomalidomide
    capsule, oral
    Other names:
    • Pomalyst
  • Drug: Dexamethasone
    oral, locally available form

More Details

Status
Active, not recruiting
Sponsor
AbbVie

Study Contact