A Study to Determine the Recommended Dose and Regimen and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

This is an open-label, multicenter, Phase 1 / 2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Inclusion Criteria

• Subjects is ≥ 18 years of age and has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
• Relapsed or refractory subjects must have measurable disease and have documented disease progression during or after their last anti-myeloma regimen.
• Newly diagnosed subjects must have documented diagnosis with previously untreated symptomatic multiple myeloma.
• Females of childbearing potential (FCBP) and male subjects must agree with the pregnancy prevention plan.

Exclusion Criteria

• Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Celgene Corporation

• Primary ID CC-92480-MM-002
• Secondary IDs NCI-2019-04130, 2018-004767-31, U1111-1233-5619
• Clinicaltrials.gov ID NCT03989414