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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

Diagnosis of multiple myeloma as per International Myeloma Working Group (IMWG) uniform criteria

Aged 18 years or older

Must not have

Known to be human immunodeficiency virus (HIV) seropositive

Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma according to IMWG standards.

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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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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I am allergic or cannot tolerate certain medications, including blood thinners, antiviral drugs, or fluids due to heart or lung problems.

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I haven't had any bleeding issues or coagulation problems in the last month.

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I am not on any cancer treatment except for steroids.

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I have been diagnosed with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis.

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I do not have an active hepatitis A, B, or C infection.

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I have severe nerve pain or damage.

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I have been treated with Selinexor before.

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I do not have a condition that affects how my body absorbs pills.

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I have not had major surgery in the last four weeks.

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I am allergic to Captisol, a substance used in some cancer drugs.

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I haven't had cancer treatment in the last 2 weeks.

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I do not have any severe mental or physical health issues that could affect my treatment.

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I do not have recent severe heart problems or uncontrolled heart rhythm issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of selinexor, carfilzomib, and dexamethasone

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

selinexor

2014

Completed Phase 1

~100

carfilzomib

2010

Completed Phase 2

~710