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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
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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:Select...
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
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
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
~9520
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
1,018 Previous Clinical Trials
734,515 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,869 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,301 Total Patients Enrolled
589 Trials studying Multiple Myeloma
189,372 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin level is not too high, unless you have Gilbert's syndrome, in which case it can be a little higher.I am HIV positive.I am allergic or cannot tolerate certain medications, including blood thinners, antiviral drugs, or fluids due to heart or lung problems.I haven't had any bleeding issues or coagulation problems in the last month.I have a measurable plasmacytoma that needs PI review before I join.I have been diagnosed with multiple myeloma according to IMWG standards.My platelet count is at least 50,000 without transfusions for 2 weeks.I am not on any cancer treatment except for steroids.I have been diagnosed with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis.My blood pressure and diabetes are not under control.I am 18 years old or older.I have been treated with at least 2 prior therapies, including a proteasome inhibitor and a cereblon-binding agent.My hemoglobin level is at least 8 g/dL without transfusions for 3 days.My liver enzyme (ALT) levels are within acceptable limits.My cancer did not respond to carfilzomib or got worse within 60 days after treatment.My white blood cell count is healthy without medication for over a week.I am a woman who can have children and my pregnancy test was negative.I have been treated with Selinexor before.I haven't needed strong infection treatment in the last 14 days.I do not have an active hepatitis A, B, or C infection.I haven't had cancer in the last 3 years, except for certain skin, thyroid, cervix, breast, or low-grade prostate cancers.I have severe nerve pain or damage.I do not have recent severe heart problems or uncontrolled heart rhythm issues.I agree to use contraception or practice abstinence during and for 3 months after treatment.I do not have a condition that affects how my body absorbs pills.You have too much M-protein in your urine over a 24-hour period.I agree to use two forms of birth control or abstain from sex during and for 3 months after treatment.You have a disease that can be measured using specific guidelines.You have a high level of M-protein in your blood.I have had fluid removed from my chest or abdomen in the last 14 days.I agree not to donate sperm during and for 3 months after my treatment.I have not had major surgery in the last four weeks.I am allergic to Captisol, a substance used in some cancer drugs.I haven't had cancer treatment in the last 2 weeks.I do not have any severe mental or physical health issues that could affect my treatment.You have very poor eyesight, according to the doctor who is treating you.I can take care of myself and am up and about more than half of the day.Your kidneys are working well enough, with a creatinine clearance of 30 mL/min or more, calculated using a special formula.Your blood test shows high levels of free light chains with an abnormal ratio.My multiple myeloma has returned or didn't respond to treatment and is getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Selinexor, carfilzomib, dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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