This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to
determine the maximum tolerated dose of CC-220 when administered as monotherapy and in
combination with dexamethasone. The study will consist of an escalating dose-escalation
portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT)
and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose
(RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
Subjects assigned to CC-220 monotherapy who develop PD will have the option to receive
Dexamethasone (DEX) in addition to CC-220 after consultation with the Medical Monitor. The
dose of CC-220 will not be higher than the dose of CC-220 used in combination with
dexamethasone that has been tested and is considered safe. Progressive disease must be
confirmed in accordance with International Myeloma Working Group ( IMWG) criteria.
The starting dose of DEX will be 40 mg Once daily (QD) on Days 1, 8, 15 and 22 of each
28-day cycle for subjects who are =75 years of age. For subjects who are >75 years of age,
the starting dose of DEX is 20 mg QD on Days 1, 8, 15 and 22 of each 28 day cycle. This
treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.
The study will be conducted in compliance with the International Conference on Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.