Multiple Myeloma
Conditions
Keywords
Relapsed or Refractory Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Multiple Myeloma, CC-92480
Brief summary
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Interventions
DRUGCC-92480
Specified dose on specified days
DRUGBortezomib
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
DRUGDaratumumab
Specified dose on specified days
DRUGCarfilzomib
Specified dose on specified days
DRUGElotuzumab
Specified dose on specified days
DRUGIsatuximab
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply: * Documented diagnosis of multiple myeloma (MM) and measurable disease * Documented disease progression during or after their last antimyeloma regimen * Achieved a response (minimal response \[MR\] or better) to at least 1 prior treatment regimen
Exclusion criteria
* Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis * Known central nervous system (CNS) involvement with myeloma * Received immunosuppressive medication within the last 14 days of initiating study treatment * Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | Up to approximately 5 years |
| Recommended Dose | Up to approximately 3 years |
| Recommended regimen as measured by dose-limiting toxicities | Up to approximately 3 years |
| Number of participants with Adverse Events (AEs) | From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-response (TTR) | Up to approximately 5 years |
| Duration of response (DOR) | Up to approximately 5 years |
| Complete Response (CR) rate | Up to approximately 5 years |
| Very good partial response (VGPR) rate - Cohorts D and E | Up to approximately 5 years |
Countries
Canada, Czechia, Denmark, France, Germany, Greece, Italy, Spain, United States
Outcome results
None listed