A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Roche-Genentech
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Pomalidomide; Thalidomide; Venetoclax

Criteria

Inclusion Criteria:

• 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 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.