A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Official Title

A Phase 1/2 Multicentre, Open-label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Summary:

This is an open-label, multi-centre, 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). RRMM patient previously treated with at least 3 prior regimens including lenalidomide or pomalidomide, a proteasome inhibitor and a CD38 antibody will be eligible.

Trial Description

Primary Outcome:

• Adverse Events (AEs)
• Pharmacokinetics- AUC
• Pharmacokinetics- Cmax
• Pharmacokinetics- Tmax
• Pharmacokinetics- t1/2
• Pharmacokinetics- CL/F
• Pharmacokinetics- Vz/F
• Maximum tolerated dose (MTD)
• Overall Response Rate (ORR)

• Overall response rate (ORR)
• Time to response (TTR)
• Duration of response (DOR)
• Progression free survival
• Overall survival (OS)
• Adverse Events (AEs)

View this trial on ClinicalTrials.gov