A Phase 2 Study Comparing Daratumumab in Combination with Carfilzomib and Dexamethasone compared with Carfilzomib and Dexamethasone in Participants with Multiple Myeloma Who Have Been Previously Treated with Daratumumab LYNX
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What's the purpose of this trial?

The purpose of this clinical trial is to determine the safety and efficacy when an investigational medicine is given for a second time to participants with multiple myeloma. This study will also compare the safety and efficacy of the investigational medicine combined with carfilzomib and dexamethasone versus carfilzomib and dexamethasone alone.

This trial is currently open and accepting patients.


What's being studied?

  • Carfilzomib is a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
  • Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments.

What will happen during the trial?

This study will enroll approximately 230 participants, and last for up to five years. This trial is divided into two different treatment groups (arms). Patients will be separated into the different arms randomly. Both Arm A and Arm B will receive treatment in 28 day cycles.

ARM A

Patients participating in Arm A will receive:

  • Carfilzomib intravenously on days 1, 8, 15 of each 28 day cycle.
  • Dexamethasone either as a pill or intravenously on days 1, 8, 15, 22 of cycles 1-9, and days 1, 8, 15 of cycles 10+.

ARM B

Patients participating in Arm B will receive:

  • Carfilzomib intravenously on days 1, 8, 15 of each 28 day cycle.
  • Dexamethasone either as a pill or intravenously on days 1, 8, 15, 22 of cycles 1-9, and days 1, 8, 15 of cycles 10 onward.
  • Daratumumab by subcutaneous injection, on days 1, 8, 15, 22 of cycles 1-2, days 1, 15 of cycles 3-6, and day 1 for cycles 7 onward.

Additional Trial Information

Phase 2

Enrollment: 230 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

  • Patients must have a diagnosis of multiple myeloma.
  • Patients must have previously received no more than 2 lines of therapy.
  • Patients must have demonstrated a partial response or better for 4 months following daratumumab exposure.
  • Patients must not have previously been treated with carfilzomib.
  • Patients must not have been previously treated with daratumumab as an injection under the skin (subcutaneous).
  • Patients must not have previously had an allogeneic stem cell transplant.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

The Oncology Institute of Hope and Innovation

Tucson, AZ

Open and Accepting

California

American Institute of Research (AIR)

Whittier, CA

Open and Accepting

Indiana

Fort Wayne Medical Oncology and Hematology Fort Wayne North Office

Fort Wayne, IN

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting
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