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Proteasome Inhibitor

Selinexor + Daratumumab + Carfilzomib + Dexamethasone for Multiple Myeloma

Phase 2
Recruiting
Led By Shebli Atrash
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented history of relapsed or relapsed/refractory MM as defined by International Myeloma Working Group (IMWG) criteria (Rajkumar et al., 2014)
Measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-treatment
Awards & highlights

Study Summary

This trial is testing the effect of adding selinexor to a regimen of carfilzomib, daratumumab, and dexamethasone for patients with high-risk multiple myeloma that has returned or stopped responding to treatment.

Who is the study for?
This trial is for adults with high-risk multiple myeloma that has returned or hasn't responded to treatment, having had 1-3 prior therapies. Participants must have adequate organ function and agree to use effective contraception. Those who've had certain toxic reactions to similar drugs, uncontrolled diseases, or specific infections can't join.Check my eligibility
What is being tested?
The study tests selinexor combined with carfilzomib, daratumumab, and dexamethasone in patients with recurrent or refractory multiple myeloma. It aims to see if this mix works better than the standard trio of drugs alone by blocking proteins that cancer cells need.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, nerve damage symptoms like numbness or tingling, allergic reactions during infusion of the drug into the vein (infusion reactions), and liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma has returned after treatment.
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My cancer can be measured by tests.
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I am not pregnant.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer returned quickly after my first treatment.
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My condition responds to Selinexor and Carfilzomib treatment.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of minimal residual disease (MRD) negative status
Secondary outcome measures
Duration of response
Incidence of adverse events
MRD negativity rate at 10^-6 of sensitivity
+4 more
Other outcome measures
Change in EORTC QLQ-C30 scores from baseline to end of treatment
Change in EORTC QLQ-MY20 scores from baseline to end of treatment
Effect of Immunomodulatory imide drug-14 scores gene expression profile (GEP) on Progression-Free Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (carfilzomib, daratumumab, dexamethasone, selinexor)Experimental Treatment5 Interventions
Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15 and daratumumab IV on days 1 and 2 of cycle 1 then days 8, 15, and 22 of cycle 1, then, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8 15, and 22, and selinexor PO on days 1, 8, and 15. 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
Selinexor
2020
Completed Phase 2
~1360
Carfilzomib
2017
Completed Phase 3
~1440
Daratumumab
2014
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,084 Total Patients Enrolled
1 Trials studying Multiple Myeloma
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,930,504 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,373 Patients Enrolled for Multiple Myeloma
Shebli AtrashPrincipal InvestigatorAcademic and Community Cancer Research United

Media Library

Multiple Myeloma Research Study Groups: Treatment (carfilzomib, daratumumab, dexamethasone, selinexor)
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT04756401 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04756401 — Phase 2

Frequently Asked Questions

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

Has Carfilzomib been cleared by the FDA?

"Carfilzomib's safety is based on early-stage clinical data, so it received a 2."

Answered by AI

What medical conditions is Carfilzomib regularly used to treat?

"Carfilzomib is a medication that ophthalmologists commonly prescribe to their patients suffering from sympathetic ophthalmia. Additionally, carfilzomib has shown efficacy in treating other medical conditions such as branch retinal vein occlusion and macular edema."

Answered by AI

At how many different medical facilities can patients enroll in this trial?

"Presently, patients are being accepted at the Iowa-Wide Oncology Research Coalition NCORP in Des Moines, Iowa, Carolinas Medical Center/Levine Cancer Institute in Charlotte, North carolina, and Aurora Cancer Care-Milwaukee West in Wauwatosa, Wisconsin. In addition to these 9 sites, there are other locations that are participating."

Answered by AI

How many individuals can join this trial at its present state?

"As of now, this study is no longer recruiting patients. The date the trial was first posted on the site was October 31st, 2022 and the last update to the listing was on September 23rd, 2022. There are 827 other trials for multiple myeloma and 676 studies involving Carfilzomib that are still looking for participants."

Answered by AI

Are there other examples of Carfilzomib being tested in a clinical setting?

"Carfilzomib was first studied 18 years ago. However, it is still being researched in many live clinical trials today, with 1298 completed studies to date. Out of the 676 ongoing trials, a significant number are based in Des Moines, Iowa."

Answered by AI

Can people sign up for this experiment right now?

"Although this specific study is not looking for patients at the moment, that information was last updated on September 23rd, 2022 and it is possible that has changed. According to clinicaltrials.gov, there are 1,503 other studies currently recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
2022. "Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04756401.
~10 spots leftby Sep 2024
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