CANOVA
Brief summary
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.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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.
