A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
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.
- Multiple Myeloma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Arm 1 VenDex
|Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.||
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.||
Study ContactABBVIE CALL CENTER