Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered intravenously (IV), to determine the MTD and NTD of both the first dose and subsequent doses of CC-93269. The expansion part (Part B) will further evaluate the safety and efficacy of CC-93269 administered IV at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the RP2D. CC-93269, administered IV followed by subcutaneously (SC), will also be evaluated (Part C). One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 2 years until confirmed disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Subjects must satisfy the following criteria to be enrolled in the study:
The presence of any of the following will exclude a subject from enrollment: