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

NOT ENROLLING
Protocol # :
19-054
Conditions
Multiple Myeloma
Phase
I/II
Disease Sites
Multiple Myeloma
Principal Investigator
Richardson, Paul, G
Site Investigator
BRANAGAN, ANDREW
Rosenblatt, Jacalyn
Site Research Nurses
Babcock, Elise
Bright, Susan
Furtado, Mollie, E.
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 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

19-054