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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03486067.
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.
Lead OrganizationCelgene Corporation
