A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma
Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
CC-220-MM-001 (primary)
NCI-2016-01463
Summary
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).
Objectives
Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have
the option to receive 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 in Cohort B that has been determined to be safe.
Progressive disease must be confirmed in accordance with international myeloma working
group (IMWG) criteria.
For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose
level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21
days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of
CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been
determined to be safe by the dose escalation committee (DEC) at the start of enrollment
for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be
administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and
DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose.
All subjects who discontinue study treatment in Part 1 or Part 2 of the study for a
reason other than PD or withdrawal of consent from the study will be followed for
response assessment every 28 days (every 21 days for Cohort F) until PD.
The study will be conducted in compliance with the International Council for
Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for
Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
The initiation of Part 2 will begin when the recommended phase 2 dose (RP2D) is
established in Part 1 in either Cohort A, Cohort B, Cohort E or Cohort F. The cohorts may
begin once the RP2D is determined for each cohort independently during Part 1. All
expansion decisions will be determined by the DEC after review of all safety, PK,
biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent
Expert Reviewer will review safety data and any other data deemed relevant so that
subject safety is ensured.
Eligibility
- 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
Treatment Sites in Georgia
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