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Anti-metabolites

Azacitidine for Multiple Myeloma

Phase 2
Waitlist Available
Led By Nina Shah, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Summary

This trial is studying how well daratumumab, azacitidine, and dexamethasone work in treating patients with multiple myeloma that has come back or has not responded to treatment.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Change in CD38 Surface Expression of Plasma Cells
Correlation of Change in CD38 Expression After Azacitidine Treatment With Depth of Response
Correlation of Change in CD38 Expression After Azacitidine With Duration of Response
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, dexamethasone, daratumumab)Experimental Treatment3 Interventions
PRE-INDUCTION (CYCLE 0): Patients receive azacitidine IV on days -7 to -3 in absence of disease progression or unacceptable toxicity. INDUCTION (CYCLES 1-2): Patients receive azacitidine IV on days 22-26, 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 (CYCLES 3-6): Patients receive azacitidine IV on days 22-26 of cycle 3 and on days 1-5 of cycles 5-6, 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 (CYCLES 7+): Patients receive azacitidine IV on days 1-5, 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2640
Azacitidine
2012
Completed Phase 3
~1440
Daratumumab
2014
Completed Phase 3
~2000

Find a Location

Who is running the clinical trial?

Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,572 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,572 Patients Enrolled for Multiple Myeloma
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,627 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,127 Patients Enrolled for Multiple Myeloma
Janssen PharmaceuticalsIndustry Sponsor
81 Previous Clinical Trials
205,158 Total Patients Enrolled
11 Trials studying Multiple Myeloma
727 Patients Enrolled for Multiple Myeloma
~1 spots leftby Jul 2025
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