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Proteasome Inhibitor

Selinexor + Carfilzomib + Dexamethasone for Multiple Myeloma (SINE Trial)

Phase 1
Recruiting
Led By Andrzej Jakubowiak
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Measurable plasmacytoma; if plasmacytoma measurement is the only measurable disease, subject eligibility must be reviewed with lead principal investigator (PI) prior to signing consent
Diagnosis of multiple myeloma as per International Myeloma Working Group (IMWG) uniform criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

SINE Trial Summary

This trial is testing selinexor, carfilzomib, and dexamethasone to see if they're effective at treating multiple myeloma.

Who is the study for?
Adults with relapsed or refractory multiple myeloma, who have tried at least two prior therapies including a proteasome inhibitor and a cereblon-binding agent. They must have measurable disease, be able to follow the study schedule, and use effective contraception if of childbearing potential. Excluded are those with recent major surgery, known allergies to certain drug components, serious medical conditions that could interfere with treatment, previous Selinexor exposure, unstable heart conditions, active infections like HIV or hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing the combination of selinexor and carfilzomib with dexamethasone to find the best dose and side effects for treating multiple myeloma that has returned after treatment or is not responding. Selinexor and dexamethasone are chemotherapy drugs while carfilzomib blocks enzymes needed for cancer cell growth.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; liver enzyme alterations; possible allergic reactions; nerve damage causing pain or numbness; as well as other organ-specific inflammation.

SINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a measurable plasmacytoma that needs PI review before I join.
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I have been diagnosed with multiple myeloma according to IMWG standards.
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My platelet count is at least 50,000 without transfusions for 2 weeks.
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I am 18 years old or older.
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I have been treated with at least 2 prior therapies, including a proteasome inhibitor and a cereblon-binding agent.
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My hemoglobin level is at least 8 g/dL without transfusions for 3 days.
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My liver enzyme (ALT) levels are within acceptable limits.
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My cancer did not respond to carfilzomib or got worse within 60 days after treatment.
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My white blood cell count is healthy without medication for over a week.
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I am a woman who can have children and my pregnancy test was negative.
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I agree to use contraception or practice abstinence during and for 3 months after treatment.
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I agree to use two forms of birth control or abstain from sex during and for 3 months after treatment.
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I agree not to donate sperm during and for 3 months after my treatment.
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I can take care of myself and am up and about more than half of the day.
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My multiple myeloma has returned or didn't respond to treatment and is getting worse.

SINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Maximum Tolerated Dose (MTD) of selinexor, carfilzomib, and dexamethasone
Secondary outcome measures
Efficacy as measured by stable disease or better (including MR, partial response, very good partial response, complete response and stringent complete response) according to IMWG criteria
Incidence of toxicities assessed using NCI CTCAE version 4.0
Incidence of toxicities related to the combination of selinexor and carfilzomib assessed using NCI CTCAE version 4.0

SINE Trial Design

1Treatment groups
Experimental Treatment
Group I: Selinexor, carfilzomib, dexamethasoneExperimental Treatment3 Interventions
Patients receive selinexor PO, carfilzomib IV, and dexamethasone PO QD or IV. Courses 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
1995
Completed Phase 3
~9860
selinexor
2014
Completed Phase 1
~100
carfilzomib
2010
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,001 Previous Clinical Trials
817,630 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,869 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,025 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,630 Patients Enrolled for Multiple Myeloma
Andrzej JakubowiakPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
219 Total Patients Enrolled
3 Trials studying Multiple Myeloma
219 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02199665 — Phase 1
Multiple Myeloma Research Study Groups: Selinexor, carfilzomib, dexamethasone
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT02199665 — Phase 1
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02199665 — Phase 1

Frequently Asked Questions

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

Are people of all ages able to participate in this research?

"Yes, the trial is currently ongoing and actively recruiting patients. The listing was first posted on June 12th, 2014 with the most recent update taking place on April 1st, 2022. They are looking for a total of 100 individuals from 3 different hospitals or clinics."

Answered by AI

Does selinexor have a solid research backing?

"Selinexor was first studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, 1149 studies have been completed with 620 more ongoing. A large number these live studies are based in Chicago, Illinois."

Answered by AI

How many people can enroll in this clinical trial at most?

"This study requires 100 individuals that meet the given criteria. These patients can enroll at locations such as University of Chicago or Mount Sinai Medical Center."

Answered by AI

What is the current status of selinexor in terms of federal regulation?

"Selinexor is still in the early stages of testing, so it received a score of 1 for safety."

Answered by AI

What are some common applications for selinexor?

"Selinexor is most often used to treat ophthalmia and sympathetic, but it has also shown efficacy in treating communicable diseases, macular edema, and branch retinal vein occlusion."

Answered by AI
~2 spots leftby Jul 2024