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

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of adding azacitidine to daratumumab and dexamethasone, as measured by the overall response rate in patients with relapsed refractory multiple myeloma (RRMM) previously treated with daratumumab. SECONDARY OBJECTIVES: I. To evaluate the duration of respo...

PRIMARY OBJECTIVE: I. To evaluate the efficacy of adding azacitidine to daratumumab and dexamethasone, as measured by the overall response rate in patients with relapsed refractory multiple myeloma (RRMM) previously treated with daratumumab. SECONDARY OBJECTIVES: I. To evaluate the duration of response per International Myeloma Working Group (IMWG) criteria. II. To evaluate the safety and tolerability of azacitidine in combination with daratumumab and dexamethasone. III. To evaluate progression free and overall survival in patients treated with azacitidine in combination with daratumumab and dexamethasone. IV. To assess the changes in CD38 expression on plasma cells after treatment with azacitidine and correlate this change with the depth and duration of response of azacitidine in combination with daratumumab and dexamethasone. OUTLINE: PRE-INDUCTION (CYCLE 0): Patients receive azacitidine intravenously (IV) on days -7 to -3 in the absence of disease progression or unacceptable toxicity. INDUCTION PHASE (CYCLES 1-2): Patients receive azacitidine IV on days 22-26 and dexamethasone IV or orally (PO) and daratumumab subcutaneously (SC) over 3-5 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE (CYCLES 3-6): Patients receive azacitidine IV on days 22-26 of cycle 3 and on days 1-5 of cycles 5-6 and dexamethasone IV or PO and daratumumab SC over 3-5 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE (CYCLES 7+): Patients receive azacitidine IV on days 1-5 and dexamethasone IV or PO and daratumumab SC over 3-5 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks for up to 1 year.

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