This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03374085 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Canada, Denmark, Finland, Greece, Japan, Korea, Republic of, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Study Website: | View Trial Website |
Experimental: Administration of CC-92480 in combination with dexamethasone
Part 1: Escalating doses of CC-92480 plus a fixed dose of dexamethasone Part 2: RP2D of CC-92480 in combination with dexamethasone
Experimental: Administration of CC-92480 monotherapy
Escalating doses of CC-92480 Monotherapy administered according to different dosing schedules
Drug: - CC-92480
CC-92480
Drug: - Dexamethasone
Dexamethasone
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Local Institution - 103
Duarte, California, 91010-300
Status
Withdrawn
Address
Berenson Oncology
West Hollywood, California, 90069
Status
Active, not recruiting
Address
Local Institution - 102
Atlanta, Georgia, 30322
Status
Active, not recruiting
Address
Local Institution - 105
Boston, Massachusetts, 02115
Status
Active, not recruiting
Address
Local Institution - 111
Buffalo, New York, 14263
Status
Active, not recruiting
Address
Local Institution - 104
New York, New York, 10065
Status
Withdrawn
Address
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Status
Active, not recruiting
Address
Local Institution - 108
Spartanburg, South Carolina, 29303
Status
Active, not recruiting
Address
Local Institution - 101
Nashville, Tennessee, 37203
Status
Active, not recruiting
Address
Local Institution - 106
Houston, Texas, 77030
Status
Active, not recruiting
Address
Local Institution - 112
Charlottesville, Virginia, 22908
Status
Active, not recruiting
Address
Local Institution - 109
Seattle, Washington, 98104
Status
Withdrawn
Address
West Virginia University - Berkeley Medical Center - Cancer and Infusion Center
Morgantown, West Virginia, 26506
Status
Recruiting
Address
Local Institution - 804
Camperdown, New South Wales, 2050
Status
Recruiting
Address
Local Institution - 802
Adelaide, South Australia, 5000
Status
Recruiting
Address
Local Institution - 805
Clayton, Victoria, 3168
Status
Recruiting
Address
Local Institution - 803
Melbourne, Victoria, 3004
Status
Recruiting
Address
Local Institution - 806
Fitzroy, , 3065
Status
Recruiting
Address
Local Institution - 904
Antwerpen, , 2060
Status
Not yet recruiting
Address
Local Institution - 903
Bruxelles, , 1200
Status
Recruiting
Address
Local Institution - 905
Gent, , 9000
Status
Recruiting
Address
Local Institution - 901
Leuven, , 3000
Status
Recruiting
Address
Local Institution - 902
Yvoir, , 5530
Status
Recruiting
Address
Local Institution - 201
Calgary, Alberta, T2N 4N2
Status
Recruiting
Address
Local Institution - 204
London, Ontario, N6C 6B5
Status
Recruiting
Address
Local Institution - 205
Ottawa, Ontario, K1H 8L6
Status
Recruiting
Address
Local Institution - 202
Toronto, Ontario, M5G 2M9
Status
Recruiting
Address
Local Institution - 206
Montreal, Quebec, H4A 3J1
Status
Recruiting
Address
Local Institution - 203
Quebec, , G1R 2J6
Status
Active, not recruiting
Address
Local Institution - 503
Aarhus N, , DK-8200
Status
Completed
Address
Local Institution - 501
Copenhagen, , 2100
Status
Completed
Address
Local Institution - 502
Odense, , 5000
Status
Active, not recruiting
Address
Local Institution - 601
Helsinki, , 00029
Status
Recruiting
Address
Local Institution - 001
Athens, , 11528
Status
Recruiting
Address
Local Institution - 705
Chuo-ku,chiba, , 260-8677
Status
Recruiting
Address
Local Institution - 703
Fukuoka, , 810-8563
Status
Recruiting
Address
Local Institution - 704
Kashiwa, , 277-8577
Status
Recruiting
Address
Local Institution - 702
Kobe-city, , 650-0047
Status
Recruiting
Address
Local Institution - 706
Kyoto-City, , 602-8566
Status
Recruiting
Address
Local Institution - 701
Okayama, , 701-1192
Status
Completed
Address
Local Institution - 152
Seoul, , 120-752
Status
Active, not recruiting
Address
Local Institution - 150
Seoul, , 135-710
Status
Active, not recruiting
Address
Local Institution - 151
Seoul, , 3080
Status
Active, not recruiting
Address
Local Institution - 403
Badalona (Barcelona), , 08916
Status
Active, not recruiting
Address
Local Institution - 407
Barcelona, , 08025
Status
Active, not recruiting
Address
Local Institution - 406
Caceres, , 10003
Status
Active, not recruiting
Address
Local Institution - 404
Madrid, , 28041
Status
Active, not recruiting
Address
Local Institution - 401
Pamplona, , 31008
Status
Active, not recruiting
Address
Local Institution - 409
Pozuelo de Alarcon, , 28223
Status
Active, not recruiting
Address
Local Institution - 402
Salamanca, , 37007
Status
Active, not recruiting
Address
Local Institution - 408
Santander, , 39008
Status
Active, not recruiting
Address
Local Institution - 405
Valencia, , 46026
Status
Active, not recruiting
Address
Local Institution - 304
Plymouth, Devon, PL6 8DH
Status
Active, not recruiting
Address
Local Institution - 306
Cardiff, , CF14 4XW
Status
Active, not recruiting
Address
Local Institution - 303
London, , NW1 2PG
Status
Active, not recruiting
Address
Local Institution - 305
Newcastle Upon Tyne, , NE7 7DN
Status
Active, not recruiting
Address
Local Institution - 302
Oxford, , OX3 7LE
Status
Active, not recruiting
Address
Local Institution - 301
Sutton, , SM2 5PT