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.
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 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 and select non-invasive malignancies, 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 87 Locations for this study
Scottsdale Arizona, 85259, United States
Little Rock Arkansas, 72205, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Fairway Kansas, 66205, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02117, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Grand Island Nebraska, 68803, United States
Grand Island Nebraska, 68803, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68130, United States
Papillion Nebraska, 68046, United States
Cherry Hill New Jersey, 08003, United States
Hackensack New Jersey, 07601, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Greenville South Carolina, 29605, United States
Memphis Tennessee, 38120, United States
Dallas Texas, 75390, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Tacoma Washington, 98405, United States
Adelaide South Australia, 5000, Australia
Box Hill Victoria, 3128, Australia
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 1, Canada
Montreal Quebec, H4A 3, Canada
Lile Cedax , 59037, France
Pessac , 33604, France
Pierre Benite cedex , 69495, France
Poitiers Cedex , 86021, France
Dresden , 01307, Germany
Dusseldorf , 40225, Germany
Hamburg , 20246, Germany
Heidelberg , 69120, Germany
Tuebingen , 72076, Germany
Wuerzburg , 97080, Germany
Jerusalem Yerushalayim, 91031, Israel
Tel Hashomer , 52620, Israel
Tel-Aviv , 64239, Israel
Meldola , 47014, Italy
Pavia , 27100, Italy
Reggio Emilia , 42100, Italy
Rome , 00161, Italy
Torino , 10126, Italy
Matsuyama Ehime, 790-8, Japan
Aomori , 030-8, Japan
Hiroshima City , 730-8, Japan
Isehara City, Kanagawa , 259-1, Japan
Kamogawa , 296-8, Japan
Kyoto-city , 602-8, Japan
Nagasaki-shi , 85285, Japan
Nagoya , 464-8, Japan
Nagoya , 467-8, Japan
Ogaki , 503-8, Japan
Osaka , 545-8, Japan
Sendai , 980-8, Japan
Shinagawa-ku, Tokyo , 141-8, Japan
Sunto-gun , 411-8, Japan
Toyohashi , 441-8, Japan
Amsterdam , 1081 , Netherlands
Maastrich , 6202 , Netherlands
Rotterdam , 3075 , Netherlands
Utrecht , 3584 , Netherlands
Badalona (Barcelona) , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Pamplona , 31008, Spain
Valencia , 46017, Spain
Birmingham , B15 2, United Kingdom
Leeds , LS9 7, United Kingdom
Oxford , OX4 6, United Kingdom
Sutton , SM2 5, United Kingdom
Sutton , SM2 5, United Kingdom
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