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 Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

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Overview

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.

SparkCures ID 1079
Trial Phase Phase 1/2
Enrollment 424 Patients
Treatments
Tags
Trial Sponsors
  • Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb
NCT Identifier

NCT03989414

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

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

Exclusion Criteria:

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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Trial Links

Read the latest news and updates on this trial.

CELMoD CC-92480/Dexamethasone Combo Shows Early Activity in Relapsed/Refractory Myeloma

December 06, 2020

CC-92480, a novel oral cereblon E3 ligase modulator (CELMoD) agent, plus dexamethasone demonstrated immunomodulatory activity across all dose levels examined in patients with relapsed/refractory multiple myeloma, according to data from the first portion of the ongoing phase 1 CC-92480-MM-001 trial (NCT03374085) presented during the 2020 ASH Annual Meeting & Exposition.

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