CANOVA - Abbvie, Protocol M13-494
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma Abbvie, Protocol M13-494
Phase III, , Peer Reviewed, Monozentrisch, National
>= 18 Jahre
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.