Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma

What's the purpose of this trial?

Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world.

Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

This trial is currently open and accepting patients.

What will happen during the trial?

Additional Trial Information

Phase 1

Enrollment: 40 patients (estimated)

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Trial Locations

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Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Kentucky

Norton Cancer Institute St. Matthews Campus

Louisville, KY

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Not Yet Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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