Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
History of multiple myeloma with relapsed and refractory disease Eastern Cooperative Oncology Group Performance Status of 0 or 1 Must have measurable disease as determined by the central laboratory
Exclusion Criteria:
Symptomatic central nervous system involvement of multiple myeloma Prior autologous stem cell transplant ≤ 3 months prior Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior History of concurrent second cancers requiring active, ongoing systemic treatment
Other protocol-defined inclusion/exclusion criteria apply
