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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.