Relapsed and refractory multiple myeloma (RRMM)
Conditions
Brief summary
Safety: Type, frequency, seriousness, severity and relationship of AEs to CC- 92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs and ECHO/MUGA scans., PK parameters: Area under the plasma concentration-time curve (AUC), maximal plasma concentration (Cmax), time to Cmax(Tmax), terminal-phase elimination half-life (t1/2),apparent total clearance of the drug from plasma after oral administration (CL/F) and apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) for CC- 92480 monotherapy and in combination with dexamethasone and the Renantiomer (CC0982796) of CC-92480 (if data allow)., Recommended Phase 2 Dose: Establish the MTD/RP2D for CC-92480 monotherapy and in combination with dexamethasone at each dosing schedule., Overall Response Rate (ORR) Best response ≥ partial response (PR), according to the IMWG Uniform Response Criteria.
Detailed description
Overall response rate (ORR): Best response ≥ PR, according to the IMWG Uniform Response Criteria., Safety: Type, frequency, seriousness, severity and relationship of AEs to CC- 92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs and ECHO/MUGA scans., Time to response (TTR): Time from 1st dose of CC-92480 to the first documentation of response ≥ PR., Duration of response (DOR): Time from the first documentation of response ( ≥ PR) to the first documentation of PD or death., Progression free survival: Time from 1st dose of CC-92480 to the first occurrence of disease progression or death from any cause., Overall survival (OS): Time from first dose of CC-92480 to death due to any cause
Interventions
Sponsors
Celgene Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Type, frequency, seriousness, severity and relationship of AEs to CC- 92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs and ECHO/MUGA scans., PK parameters: Area under the plasma concentration-time curve (AUC), maximal plasma concentration (Cmax), time to Cmax(Tmax), terminal-phase elimination half-life (t1/2),apparent total clearance of the drug from plasma after oral administration (CL/F) and apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) for CC- 92480 monotherapy and in combination with dexamethasone and the Renantiomer (CC0982796) of CC-92480 (if data allow)., Recommended Phase 2 Dose: Establish the MTD/RP2D for CC-92480 monotherapy and in combination with dexamethasone at each dosing schedule., Overall Response Rate (ORR) Best response ≥ partial response (PR), according to the IMWG Uniform Response Criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR): Best response ≥ PR, according to the IMWG Uniform Response Criteria., Safety: Type, frequency, seriousness, severity and relationship of AEs to CC- 92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs and ECHO/MUGA scans., Time to response (TTR): Time from 1st dose of CC-92480 to the first documentation of response ≥ PR., Duration of response (DOR): Time from the first documentation of response ( ≥ PR) to the first documentation of PD or death., Progression free survival: Time from 1st dose of CC-92480 to the first occurrence of disease progression or death from any cause., Overall survival (OS): Time from first dose of CC-92480 to death due to any cause | — |
Countries
Belgium, Spain
Outcome results
None listed