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Selinexor + Carfilzomib + Dexamethasone for Multiple Myeloma (SINE Trial)
SINE Trial Summary
This trial is testing selinexor, carfilzomib, and dexamethasone to see if they're effective at treating multiple myeloma.
SINE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSINE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SINE Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Selinexor, carfilzomib, dexamethasone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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