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Proteasome Inhibitor
Selinexor Combination Therapy for Multiple Myeloma
Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the outcomes of patients with RRMM who are treated with selinexor-based combination therapy to those who are treated with ex vivo drug sensitivity testing results.
Who is the study for?
This trial is for adults over 18 with relapsed or refractory multiple myeloma, who have measurable disease and whose cancer has progressed after treatment. They must be able to consent, have an ECOG Performance Status of ≤2, adequate organ function, and agree to use effective contraception. Excluded are those with certain heart conditions, uncontrolled medical issues, previous selinexor therapy, major surgery within the last month or active infections.Check my eligibility
What is being tested?
The trial tests Selinexor combined with other drugs in three different mixes (SPd: Selinexor + pomalidomide + dexamethasone; SDd: Selinexor + daratumumab + dexamethasone; SKd: Selinexor + carfilzomib + dexamethasone) against multiple myeloma. Participants will be assigned to one of these treatment arms based on physician's choice compared to drug sensitivity testing results.See study design
What are the potential side effects?
Selinexor and its combinations may cause side effects like nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems. Other possible side effects include liver enzyme changes indicating potential liver damage and gastrointestinal symptoms such as loss of appetite or difficulty swallowing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 multiple myeloma worsened after initially responding to treatment.
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My blood counts meet the required levels for the trial.
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My kidney function is good based on my creatinine levels or clearance.
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I am using effective birth control and have a negative pregnancy test if I'm of childbearing age.
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My multiple myeloma has worsened after at least one treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response rate
Secondary outcome measures
Duration of Response
MRD negative response rate
Overall Survival
+3 moreOther outcome measures
Evaluation of My-DST related predictors of response
Feasibility of My-DST testing to inform treatment choice
Reliability of My-DST testing to inform treatment choice
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3 SKdExperimental Treatment3 Interventions
Selinexor 80 mg PO days 1, 8, 15
Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
28 day treatment cycle
Group II: Arm 2 SDdExperimental Treatment3 Interventions
Selinexor 80 mg PO days 1, 8, 15
Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles >6
Dexamethasone 40 mg PO or IV days 1, 8, 15, 22
28 day treatment cycle
Group III: Arm 1 SPdExperimental Treatment3 Interventions
Selinexor 60 mg PO days 1, 8, 15
Pomalidomide 4 mg PO on days 1-21
Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
28 day treatment cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Carfilzomib
2017
Completed Phase 3
~1440
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,501 Total Patients Enrolled
3 Trials studying Multiple Myeloma
41 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,554 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,195 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,926,004 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,106 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack in the last 3 months.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My liver is working well.Patients must have a disease that can be measured.My multiple myeloma worsened after initially responding to treatment.I am willing and able to take medications for nausea and appetite loss as recommended.I am allergic or cannot take certain medications required for the trial.Your total bilirubin levels should be within a certain range, unless you have Gilbert's syndrome, in which case there's a different range for you.I experience chest pain due to poor blood flow to my heart.My most recent treatment for multiple myeloma did not work well.Your blood test shows high levels of free light chains, and the ratio of these chains is abnormal.I have a tumor larger than 2cm that can be tracked with imaging.I have controlled Hep B, untreated Hep C, or stable HIV with no recent severe infections.My heart condition is stable.My heart's pumping ability is significantly reduced.I do not have serious heart rhythm problems that are not under control.I have no stomach or bowel problems that affect my ability to swallow pills or absorb medication.I am allowed to use medications to support my blood cell levels.I am allergic or cannot tolerate the study drugs.My blood counts meet the required levels for the trial.You are excreting at least 200 mg of protein in your urine every 24 hours.You have a high level of M-protein in your blood.I have not had major surgery in the last 4 weeks.My kidney function is good based on my creatinine levels or clearance.I do not have an active infection needing IV drugs within the last week.I do not have any uncontrolled conditions like high blood pressure or diabetes that could affect the study.I have previously been treated with selinexor or a similar drug.I can have blood or platelet transfusions if needed during the study.I am using effective birth control and have a negative pregnancy test if I'm of childbearing age.Your liver enzymes (AST and ALT) are within the normal range or not more than 2.5 times the upper limit of normal.My multiple myeloma has worsened after at least one treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 SPd
- Group 2: Arm 2 SDd
- Group 3: Arm 3 SKd
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are able to join this clinical research project?
"Yes, according to the most recent information available on clinicaltrials.gov, this trial is still looking for patients. This particular study was posted on November 18th 2021 and was last updated December 30th 2021. They are hoping to find 25 participants at 1 site."
Answered by AI
What therapeutic benefits has Selinexor been shown to provide?
"Selinexor is most often used to treat ophthalmia, sympathetic. It can also be administered to treat a variety of other conditions including branch retinal vein occlusion, macular edema, communicable diseases."
Answered by AI
Are there any available openings for people who want to participate in this clinical trial?
"By reviewing the information on clinicaltrials.gov, it appears that this study is currently recruiting patients. The trial was originally posted on November 18th 2021 and was edited December 30th 2021. Up to 25 people are needed for the research taking place at a single location."
Answered by AI
What are some of the most severe reactions people have had to Selinexor?
"Selinexor is currently in Phase 2 of clinical trials. While there is evidence that suggests it may be safe, more research needs to be done to confirm its efficacy."
Answered by AI
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