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.

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Pomalidomide; Drug: Venetoclax; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03539744

2023-506112-40 (Other Identifier)

M13-494

Details and patient eligibility

About

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.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Arm 1 VenDex

Experimental group

Description:

Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.

Treatment:

Drug: Dexamethasone

Drug: Venetoclax

Arm 2 PomDex

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Pomalidomide