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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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

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

Do I qualify?Apply below to find out

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

Recent research and studies

clinicaltrials.govStudy

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

2020. "Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04407442.