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. All eligible subjects must be refractory to their last line of therapy and have failed, be intolerant to or are not otherwise candidates for available therapies demonstrated to confer clinical benefit to subjects with relapsed and refractory multiple myeloma including (at a minimum), thalidomide, lenalidomide or pomalidomide and a proteasome inhibitor.

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