A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Required: CCND1 t(11;14)

Show the (11;14), as demonstrated by FISH or cytogenetic analysis at screening or at any point prior to screening

Must have received: proteasome inhibitor

Participant must have received at least 1 prior line of therapy for multiple myeloma, including a proteasome inhibitor, lenalidomide, and glucocorticosteroids but not necessarily in one treatment regimen

Must have received: immunomodulatory agent (lenalidomide)

Participant must have received at least 1 prior line of therapy for multiple myeloma, including a proteasome inhibitor, lenalidomide, and glucocorticosteroids but not necessarily in one treatment regimen

Must have received: glucocorticosteroid

Participant must have received at least 1 prior line of therapy for multiple myeloma, including a proteasome inhibitor, lenalidomide, and glucocorticosteroids but not necessarily in one treatment regimen

Cannot have received: anti-CD38 antibody (daratumumab, isatuximab)

Exception: allowed if last dose >3 weeks before enrollment and best response was at least MR

Treatment with an anti-CD38 antibody (daratumumab or isatuximab) within the last 3 weeks; For those patients treated with an anti-CD38 antibody (daratumumab or isatuximab), alone or in combination, without achieving a best response of at least MR

Cannot have received: BCL2 inhibitor (venetoclax)

Treatment with venetoclax

Cannot have received: chemotherapy

Exception: allowed if >3 weeks before starting study drugs

Chemotherapy within 3 weeks of starting study drugs

Cannot have received: corticosteroid

Exception: allowed if ≤20 mg/day prednisone or equivalent, or >3 weeks before starting study drugs

Corticosteroids (>20 mg per day prednisone or equivalent) within 3 weeks of starting study drugs

Cannot have received: immunotherapy

Exception: allowed if >3 weeks before starting study drugs

Immunotherapy, antibody therapy, immunomodulatory agents, or proteasome inhibitors within 3 weeks of starting study drugs

Cannot have received: antibody therapy

Exception: allowed if >3 weeks before starting study drugs

Immunotherapy, antibody therapy, immunomodulatory agents, or proteasome inhibitors within 3 weeks of starting study drugs

Cannot have received: immunomodulatory agent

Exception: allowed if >3 weeks before starting study drugs

Immunotherapy, antibody therapy, immunomodulatory agents, or proteasome inhibitors within 3 weeks of starting study drugs

Cannot have received: proteasome inhibitor

Exception: allowed if >3 weeks before starting study drugs

Immunotherapy, antibody therapy, immunomodulatory agents, or proteasome inhibitors within 3 weeks of starting study drugs

Cannot have received: radiation therapy

Exception: allowed if localized or >28 days before starting study drugs

Extensive radiation therapy within 28 days of starting study drugs. Receipt of localized radiation therapy does not preclude enrollment

Cannot have received: investigational therapy

Exception: allowed if >28 days before starting study drugs

Use of any other experimental drug or therapy within 28 days of starting study drugs

Cannot have received: anticancer therapy

Exception: allowed if >5 half-lives prior to first dose and throughout venetoclax administration

Anticancer therapies including chemotherapy, radiotherapy, or other investigational therapy, including targeted small molecule agents: Excluded 5 half-lives prior to first dose and throughout venetoclax administration

Cannot have received: biologic agent

Exception: allowed if >21 days prior to first dose and throughout venetoclax administration

Biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent: Excluded 21 days prior to first dose and throughout venetoclax administration