Multiple Myeloma
Conditions
Brief summary
Establish the maximum tolerated doses and or Recommended Phase 2 doses of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab in combination with DEX and bortezomib, and in combination with DEX and carfilzomib., Overall response rate (ORR) in Cohort D -Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) in CC-220 in combination with DEX
Detailed description
Safety - Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product, Very good partial response or better rate (VGPR) - Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for subjects who achieved VGPR or better., Overall response rate (ORR) - Tumour response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for subjects who achieved partial response (PR) or better, Time to response (TTR) - Time from enrollment to the first documentation of response (PR or greater)., Duration of response (DOR)- Time from the first documentation of response (PR or greater) to the first documentation of PD., Progression free survival (PFS) - Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first., Overall Survival (OS) in Part 2 RRMM cohorts- Time from first dose of IP to death due to any cause., Pharmacokinetic (PK) parameters- PK of CC-220, and as appropriate, its R-enantiomer CC-17195 in plasma, eg, area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval (AUC(TAU)), maximum plasma concentration of drug (Cmax), time to Cmax (Tmax)
Interventions
DRUGIberdomide
DRUGDARZALEX 1800 mg solution for injection
Sponsors
Celgene Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the maximum tolerated doses and or Recommended Phase 2 doses of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab in combination with DEX and bortezomib, and in combination with DEX and carfilzomib., Overall response rate (ORR) in Cohort D -Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) in CC-220 in combination with DEX | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product, Very good partial response or better rate (VGPR) - Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for subjects who achieved VGPR or better., Overall response rate (ORR) - Tumour response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for subjects who achieved partial response (PR) or better, Time to response (TTR) - Time from enrollment to the first documentation of response (PR or greater)., Duration of response (DOR)- Time from the first documentation of response (PR or greater) to the first documentation of PD., Progression free survival (PFS) - Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whicheve | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed