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

Official Title

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

Summary:

This is an open-label, multi-centre, international, Phase 1 study to assess the safety, PK/PD and preliminary efficacy of CC-92480 in combination with dexamethasone in subjects with 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)
• Time to response (TTR)
• Duration of response (DOR)
• Progression free survival

View this trial on ClinicalTrials.gov