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, Therapeutisch, Peer Reviewed, Multizentrisch, International
>= 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.
Studienaktive Standorte
Rekrutierung läuft
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie
Herr Prof. Dr. Martin Kortüm
Frau Efstathia Dölken