NCT04407442: Phase 2: Dara, Azacitidine & Dex for RRMM Myeloma Previously Treated With Daratumumab

NCT04407442: Phase 2: Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab

Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab

This phase II trial studies how well daratumumab, azacitidine, and dexamethasone work in treating patients with multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory) and was previously treated with daratumumab. Daratumumab is an antibody made up of immune cells that attaches to a protein on myeloma cells, called cluster of differentiation 38 (CD38). CD38 is found in higher levels on tumor cells than on normal cells. Daratumumab prevents the growth of tumors who have high levels of CD38 by causing those cells to die. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is a steroid that helps decrease inflammation and lowers the body's normal immune response to help reduce the effect of any infusion-related reactions. Giving azacitidine may help increase the levels of CD38 on the tumor cells to increase the function of daratumumab to attach to those tumor cells to help destroy them.

Sponsor

University of California, San Francisco

Collaborators

Janssen Pharmaceuticals

Multiple Myeloma Research Foundation

Locations

United States, California

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ClinicalTrials.gov Identifier: NCT04407442

Official Title: Phase II Study of Daratumumab in Combination With Azacitidine and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated With Daratumumab

First Posted : May 29, 2020