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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
Relapse is defined as progression of disease after an initial response (minimal response (MR) or better) to previous treatment, more than 60 days after cessation of treatment
Prior exposure to daratumumab, with most recent dose being at least 6 months prior to trial enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your disease has worsened again after it had initially responded to previous treatment, and this happened more than 60 days after stopping the treatment.
Select...
You have taken daratumumab in the past 6 months.

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
Body Weight Changes
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
~2590
Azacitidine
2012
Completed Phase 3
~1440
Daratumumab
2014
Completed Phase 3
~1860

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
2,500 Previous Clinical Trials
15,236,466 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,195 Patients Enrolled for Multiple Myeloma
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,066 Total Patients Enrolled
11 Trials studying Multiple Myeloma
727 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Azacitidine most often employed therapeutically?

"ophthalmia, sympathetic is most commonly treated with Azacitidine. Azacitidine can also be useful for treating other conditions like complete blood count, induction chemotherapy, and branch retinal vein occlusion."

Answered by AI

Can patients sign up for this research project at this time?

"The latest information from clinicaltrials.gov suggests that this study is still looking for test subjects. The first posting was on November 30th, 2020 and the page was updated as recently as August 9th, 2022."

Answered by AI

Are there any dangers associated with taking Azacitidine?

"Azacitidine is a medication that, while having some evidence of safety from Phase 2 clinical trials, has not been proven effective."

Answered by AI

How many test subjects are participating in this experiment?

"That is correct, the clinicaltrials.gov website contains current information about this study's status. The trial was first posted on 11/30/2020 and updated as recently as 8/9/2022. They are enrolling 23 participants at 1 site."

Answered by AI
~1 spots leftby Apr 2025