A PHASE 1B/2A MULTICENTER, OPEN-LABEL, DOSEESCALATION STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE, ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF CC-220 AS MONOTHERAPY AND IN COMBINATION WITH OTHER TREATMENTS IN SUBJECTS WITH MULTIPLE MYELOMA
Trial Description
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study
consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in
combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX
and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2)
for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple
Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX
and DARA for Newly Diagnosed Multiple Myeloma (NDMM).
Eligibility Requirements
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Relapsed and refractory multiple myeloma (RRMM) participants must have documented
disease progression on or within 60 days from the last dose of their last myeloma
therapy
- Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis
with previously untreated symptomatic multiple myeloma (MM)
- Participants in Cohorts J1 and K are those for whom autologous stem cell
transplantation is not planned for initial therapy or are not considered by the
investigator as eligible for high-dose chemotherapy and autologous stem cell
transplantation
Exclusion Criteria:
- Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the participant from participating in the study
- Nonsecretory multiple myeloma
- Prior history of malignancies, other than MM and select non-invasive malignancies,
unless the participant has been free of the disease for ≥ 5 years
Other protocol-defined inclusion/exclusion criteria apply