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
  • CC-92480
  • Dexamethasone
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.

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma that continued to grow or came back despite prior treatment that included a proteasome inhibitor (bortezomib or carfilzomib) and a CM agent.
  • At least 4 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

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. Subjects must have measurable disease and documented disease progression on or within 60 days from the last dose of their last myeloma therapy and have failed treatment with, are intolerant to or are not otherwise candidates for available therapies.
  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<br />

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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<br />

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

Massachusetts
New York
Tennessee
Texas

Resources

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