Relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM (NDMM)
Conditions
Brief summary
Recommend Dose and Regimen: Review of dose-limiting toxicities (DLTs), safety, and if applicable, pharmacokinetics (PK), pharmacodynamics (Pd), and/or preliminary efficacy data by the Safety Review Committee (SRC)., Safety: Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment., Overall response rate (ORR): Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria.
Detailed description
Time-to-response (TTR) Time from first dose 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 progressive disease (PD) or death, Complete Response (CR) rate Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria, Very good partial response (VGPR) rate (Cohorts D and E) Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria.
Interventions
DRUGCC-92480
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGDexamethason 4 mg JENAPHARM®
DRUGKyprolis 60 mg powder for solution for infusion
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 |
|---|---|
| Recommend Dose and Regimen: Review of dose-limiting toxicities (DLTs), safety, and if applicable, pharmacokinetics (PK), pharmacodynamics (Pd), and/or preliminary efficacy data by the Safety Review Committee (SRC)., Safety: Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment., Overall response rate (ORR): Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-response (TTR) Time from first dose 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 progressive disease (PD) or death, Complete Response (CR) rate Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria, Very good partial response (VGPR) rate (Cohorts D and E) Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria. | — |
Countries
Denmark, France, Germany, Greece, Italy, Spain
Outcome results
None listed