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

Overview

The purpose of this study is to assess the safety of treatment with the investigational drug CC-92480 in combination with dexamethasone for patients with multiple myeloma that has come back or continued to grow despite standard therapy. CC-92480 is a type of drug called a "cereblon-modifying (CM) agent."

Other CM agents used to treat multiple myeloma include thalidomide, lenalidomide, and pomalidomide. CC-92480 is a new CM agent that is thought to be more effective for targeting and destroying proteins that help to produce myeloma cells. The effect of CC-92480 may be increased when it is used in combination with dexamethasone, a standard part of myeloma treatment. Both CC-92480 and dexamethasone are taken orally (by mouth).

SparkCures ID 935
Trial Phase Phase 1
Enrollment 120 Patients
Treatments
Tags
Trial Sponsors
  • Celgene Corporation
NCT Identifier

NCT03374085

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. Subject is ≥ 18 years of age and ECOG performance status score of 0, 1 or 2
  2. All subjects must have:
    1. received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen),
    2. documented disease progression on or within 60 days from the last dose of their last myeloma therapy,
    3. in addition to criteria above (a and b), subjects enrolled in Part 2 must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose.
  3. Subjects must have adequate bone marrow, renal, liver, and cardiac function.
  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 has non- or oligosecretory multiple myeloma.
  3. Subject is unable or unwilling to undergo protocol required venous thromboembolism (VTE) prophylaxis.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Winship Cancer Institute of Emory University

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Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

California
Colorado
Georgia
Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more

Massachusetts
Tennessee
Texas

Published Results

First-in-human phase I study of the novel CELMoD agent CC-92480 combined with dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM)

June 01, 2020

  • As of Dec 24, 2019, 66 pts had received CC-92480 + dexamethasone.
  • Most frequent grade 3–4 treatment-emergent adverse events included neutropenia (53%), infections (30%), anemia (29%), and thrombocytopenia (17%), with 9% grade 3 fatigue.
  • Overall response rate (ORR) was 21% (9 very good partial responses [VGPRs]; 5 PRs) for efficacy evaluable population (n = 66).

Resources

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