Azacitidine for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, San Francisco, CAMultiple Myeloma+1 MoreAzacitidine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Next Generation Sequencing
1
FT576
1
Ascorbate

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 18 months

Day 28
Number of patients who achieve at least 1.5 fold increase in their CD38 expression
Day 34
Body Weight Changes
Up to 18 months
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
Correlation of change in CD38 expression after azacitidine with overall response
Duration of Response (DOR)
Incidence of treatment-related adverse events (AE)
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Next Generation Sequencing
1
FT576
1
Ascorbate

Trial Design

1 Treatment Group

Treatment (azacitidine, dexamethasone, daratumumab)
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Azacitidine · No Placebo Group · Phase 2

Treatment (azacitidine, dexamethasone, daratumumab)Experimental Group · 3 Interventions: Dexamethasone, Azacitidine, Daratumumab · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Azacitidine
FDA approved
Daratumumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 months

Who is running the clinical trial?

Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
7,467 Total Patients Enrolled
10 Trials studying Multiple Myeloma
7,467 Patients Enrolled for Multiple Myeloma
University of California, San FranciscoLead Sponsor
2,312 Previous Clinical Trials
11,758,333 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,133 Patients Enrolled for Multiple Myeloma
Janssen PharmaceuticalsIndustry Sponsor
72 Previous Clinical Trials
18,984 Total Patients Enrolled
8 Trials studying Multiple Myeloma
597 Patients Enrolled for Multiple Myeloma
Nina Shah, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
130 Total Patients Enrolled
2 Trials studying Multiple Myeloma
130 Patients Enrolled for Multiple Myeloma
Alfred Chung, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Multiple Myeloma
25 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years old or older.
Your platelet count is at least 75,000 per microliter of blood.
Your bilirubin levels are normal, unless you have Gilbert's syndrome. If you have Gilbert's syndrome, your direct bilirubin levels should be normal.
You have high levels of abnormal proteins in your blood or urine. If there are no measurable levels of abnormal proteins, you have an abnormal ratio of certain proteins in your blood.
Your disease has not responded well to previous treatments.
You have tried at least two different treatments for your condition, including drugs and therapies, but your condition has not improved.
You are able to perform daily activities and your overall health is good.
You have enough infection-fighting white blood cells in your body (neutrophils) with a count of at least 1,500 per microliter.
Your disease has worsened again after it had initially responded to previous treatment, and this happened more than 60 days after stopping the treatment.
You have taken daratumumab in the past 6 months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top