Multiple Myeloma Clinical Trial
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
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 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
Full Description
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.
The starting dose of DEX will be 40 mg for subjects who are ≤75 years of age and 20 mg for subjects who are >75 years of age, given once weekly. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.
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 with a minimal response (MR) or better 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 RP2D is established in Part 1 in either Cohort A or Cohort B. Either cohort 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 Criteria
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, unless the participant has been free of the disease for ≥ 5 years
Other protocol-defined inclusion/exclusion criteria apply
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There are 101 Locations for this study
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72205, United States
Maywood Illinois, 60153, United States
Baltimore Maryland, 21229, United States
Boston Massachusetts, 02215, United States More Info
Ann Arbor Michigan, 48109, United States More Info
Grand Island Nebraska, 68803, United States More Info
Grand Island Nebraska, 68803, United States More Info
Omaha Nebraska, 68114, United States More Info
Omaha Nebraska, 68124, United States More Info
Papillion Nebraska, 68046, United States More Info
Brooklyn New York, 11234, United States
New York New York, 10011, United States
New York New York, 10016, United States More Info
Contact
New York New York, 10029, United States More Info
New York New York, 10065, United States More Info
Charlotte North Carolina, 28204, United States More Info
Contact
Philadelphia Pennsylvania, 19104, United States
Greenville South Carolina, 29605, United States
Dallas Texas, 75390, United States
Salt Lake City Utah, 84112, United States More Info
Bonney Lake Washington, 98391, United States
Federal Way Washington, 98003, United States
Gig Harbor Washington, 98332, United States
Puyallup Washington, 98373, United States
Seattle Washington, 98109, United States More Info
Contact
Westmead New South Wales, 2145, Australia
Afula , 18341, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Napoli , 80131, Italy
Kyoto-city , 602-8, Japan
Sendai , 980-8, Japan
Rotterdam , 3075 , Netherlands
Birmingham , B15 2, United Kingdom
Sutton , SM2 5, United Kingdom
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