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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

Enrolling

Trial ID:NCT02773030

View complete trial on ClinicalTrials.gov

Protocol #:19-054

877-DF-TRIAL (877-338-7425)

Condition(s):Multiple Myeloma

Phase:I/II

Principal Investigator:Richardson, Paul, G

Site Investigator(s):BRANAGAN, ANDREW,
Rosenblatt, Jacalyn,

Site Research Nurse(s):Babcock, Elise,
Bright, Susan,
Knudsen, Elisabeth,
Marzullo, Tess, V.
Nutter, Meredith, Elise
Packer, Lisette, A.
Smith, Caitlin,

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 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

Eligibility Requirements:
- 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, unless the participant has been free of the disease for ≥ 5 years
Other protocol-defined inclusion/exclusion criteria apply

Protocol #: 19-054

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)