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Daratumumab Combo for Multiple Myeloma

Phase 2
Recruiting
Led By Cara Rosenbaum, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Relapsed and/or refractory myeloma meeting specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

Study Summary

This trial is testing whether a combination of drugs will work better than a historical treatment for relapsed or refractorymultiple myeloma patients.

Who is the study for?
This trial is for adults with Multiple Myeloma that has come back or hasn't responded to treatment. They must have measurable disease, be able to take aspirin, and not be pregnant or breastfeeding. Participants should be in decent physical shape (ECOG 0-2) and expected to live more than 3 months. They can't join if they've had certain treatments recently, other cancers, severe illnesses that could affect the study, allergies to the drugs used in this trial, or some heart/lung conditions.Check my eligibility
What is being tested?
The study tests a combination therapy called D-ClaPd on patients who've previously been treated with Daratumumab. It's a phase II trial where participants receive Daratumumab subcutaneously along with Clarithromycin/Pomalidomide/Dexamethasone until their disease progresses or side effects become too much.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for Daratumumab SC; nausea, taste changes from Clarithromycin; blood clots and fatigue from Pomalidomide; and weight gain, high blood sugar from Dexamethasone. There may also be an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My myeloma has returned or is not responding to treatment.
Select...
My condition is confirmed as Multiple Myeloma through tissue analysis.
Select...
I can take aspirin every day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Very Good Partial Response Rate or better within 8 cycles of induction therapy
Secondary outcome measures
Complete Response Rate or Better
Duration of Response
Overall Response Rate
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: daratumumab/clarithromycin/pomalidomide/dexamethasoneExperimental Treatment4 Interventions
Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clarithromycin
2017
Completed Phase 4
~3950
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,255 Total Patients Enrolled
18 Trials studying Multiple Myeloma
731 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,478 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,056 Patients Enrolled for Multiple Myeloma
Cara Rosenbaum, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Clarithromycin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04302324 — Phase 2
Multiple Myeloma Research Study Groups: daratumumab/clarithromycin/pomalidomide/dexamethasone
Multiple Myeloma Clinical Trial 2023: Clarithromycin Highlights & Side Effects. Trial Name: NCT04302324 — Phase 2
Clarithromycin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04302324 — Phase 2

Frequently Asked Questions

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

Is this trial actively seeking participants at the present time?

"Affirmative. Per the details on clinicaltrials.gov, this research endeavour is actively seeking participants as of June 8th 2022. It was initially posted October 28th 2021 and requires 40 patients from 1 medical centre to participate in it."

Answered by AI

What criteria must potential participants meet in order to be included in this experiment?

"This clinical trial seeks to enrol 40 myeloma patients aged between 18 and 75. To be considered, applicants must meet the following criteria: Relapsed or refractory status relative to prior daratumumab usage with 8 doses administered at least 3 months apart; a life expectancy of greater than three months; and an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2."

Answered by AI

To what capacity is the patient population being increased for this medical research?

"Affirmative. The clinical trial is still recruiting, as evidenced by the information on clinicaltrials.gov; it was initially advertised on October 28th 2021 and last amended on June 8th 2022. 40 individuals need to be recruited from one single location for this study."

Answered by AI

Is there any precedent for utilizing Daratumumab in medical investigations?

"Today, 646 investigations into the potential of Daratumumab are currently underway. Of those studies, 158 have advanced to Phase 3 trials - many based in Mishawaka, Indiana but with a total of 20303 sites across the globe recruiting participants."

Answered by AI

To what illnesses is Daratumumab regularly prescribed?

"Daratumumab is traditionally used to treat ophthalmia and sympathetic. Alternatively, this medication can be prescribed for branch retinal vein occlusion, macular edema, communicable diseases as well."

Answered by AI

Is this investigation recruiting elderly individuals?

"As stated in the eligibility requirements, any individual between 18 and 75 years of age may take part this trial."

Answered by AI

Has the US Food and Drug Administration sanctioned the use of Daratumumab?

"The safety profile of Daratumumab is evaluated as a 2 since this Phase 2 trial has data that demonstrates its security but no evidence to demonstrate efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
2021. "A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04302324.
~5 spots leftby Sep 2024
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