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Monoclonal Antibodies
Combination Therapies with Selinexor for Multiple Myeloma (STOMP Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to (≥) 18 years at the time of informed consent
Any non-hematological toxicities (except for peripheral neuropathy as described in exclusion criterion #22) that patients had from treatments in previous clinical studies must have resolved to less than or equal (≤) Grade 2 by C1D1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
STOMP Trial Summary
This trial will assess the efficacy and safety of 10 different combination therapies in 11 arms for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM).
Who is the study for?
Adults over 18 with symptomatic multiple myeloma, either newly diagnosed or relapsed/refractory, can join. They must have measurable disease and be in good enough health to swallow pills and handle treatment side effects. Pregnant women, those with severe liver/kidney issues, recent major surgery patients, or individuals with certain infections or heart problems cannot participate.Check my eligibility
What is being tested?
The trial is testing Selinexor combined with other drugs like dexamethasone and chemotherapy agents in different mixtures across 11 groups for treating multiple myeloma. Some groups are closed to new participants. The study includes initial phases to determine safe dosages followed by expansions to assess effectiveness.See study design
What are the potential side effects?
Potential side effects include digestive issues that could affect tablet absorption, blood disorders requiring transfusions or growth factors, nerve pain if previously experienced at a high level (for specific arms), eye conditions from certain drug combinations (Arm 10), and possible allergic reactions.
STOMP Trial 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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Any side effects from past treatments have mostly gone away.
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I have symptoms from my multiple myeloma.
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I can take care of myself but might not be able to do heavy physical work.
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I am a woman who can have children and my pregnancy test was negative.
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My myeloma has returned or didn't respond to treatment and can be measured.
STOMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf)
Phase 1 (Dose-escalation): Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor
Phase 1 (Dose-escalation): Maximum Plasma Concentration (Cmax) of Selinexor
+5 moreSTOMP Trial Design
12Treatment groups
Experimental Treatment
Group I: 9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)Experimental Treatment4 Interventions
PK Run-in Period: Selinexor and Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-Escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days
Cohort 9.1:
SEL 20/40/60 mg PO once weekly; DEX 28/20 mg PO twice weekly; POM 4 mg PO QD Days 1-21; Elotuzumab (ELO) 10/20 mg/kg IV will be given once weekly on Days 1,8, 15 and 22 of Cycles 1-2. Starting on Cycle 3 and continuing for future cycles, elotuzumab will be dosed at 20 mg/kg on Day 1 of each cycle only.
Cohort 9.3: Selinexor, Dexamethasone, Pomalidomide and Elotuzumab will be dosed at RP2D-9.
Group II: 8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd)Experimental Treatment4 Interventions
PK Run-in Period: Selinexor & Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-Escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days
Cohort 8.1:
SEL 40/60/80/100 mg PO once weekly; DEX 20 mg PO twice weekly; IXA 3/4 mg PO once weekly.
Cohort 8.3: Selinexor, Dexamethasone and Ixazomib will be dosed at RP2D-8.
Group III: 7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMMExperimental Treatment3 Interventions
Each cycle is of 28 days
Cohort 7.1:
SEL 40/60/80 mg PO once weekly; DEX 40 mg PO once weekly; LEN 25 mg PO Days 1-21.
Cohort 7.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-7.
Group IV: 6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd)Experimental Treatment4 Interventions
PK Run-in Period: Selinexor and Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-Escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days
Cohort 6.1:
SEL 40/60/80/100 mg PO once weekly on days 1, 8, 15, and 22; DEX 40 mg IV or PO once weekly; Carfilzomib (CAR) 56 or 70 mg/m^2 IV infusion once weekly on days 1, 8, and 15.
Cohort 6.2:
SEL 60/80/100 mg PO once weekly on days 1, 8, and 15; DEX 40 mg IV or PO once weekly; CAR 56 or 70 mg/m^2 IV infusion once weekly on days 1, 8, and 15.
Cohort 6.3: Selinexor, Dexamethasone and Carfilzomib will be dosed at RP2D-6.
Group V: 5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd)Experimental Treatment3 Interventions
Each cycle is of 28 days
Cohort 5.1:
SEL 80/100 mg PO once weekly; DEX 40 mg once weekly (IV or PO); DARA: 16 mg/kg IV infusion Cycle 1-2: Once weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month.
Cohort 5.2:
SEL: 60 mg PO twice weekly; DEX: 40 mg weekly (IV or PO); DARA: 16 milligram per kilogram (mg/kg) IV infusion Cycle 1-2: Once. weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month.
Cohort 5.3: Selinexor, Dexamethasone and Daratumumab will be dosed at RP2D-5.
Group VI: 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd)Experimental Treatment5 Interventions
PK Run-in Period: Selinexor and Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patients will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days.
Cohort 4.1:
SEL 40/60 mg PO once weekly; DEX 40 mg PO once weekly; POM 4 mg PO Days 1-21; BOR 1.3 mg/m^2 subcutaneous (SC) once weekly.
Cohort 4.3: Selinexor, Dexamethasone, Pomalidomide, Velcade (Bortezomib) will be dosed at RP2D-4.
Group VII: 3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMMExperimental Treatment3 Interventions
Each cycle is of 28 days
Cohort 3.1: SEL 40/60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Lenalidomide (LEN) 15/25 mg PO Days 1-21.
Cohort 3.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; LEN 15/25 mg PO Days 1-21.
Cohort 3.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-3.
Group VIII: 2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd)Experimental Treatment3 Interventions
Each cycle is of 35 days
Cohort 2.1: SEL 60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Bortezomib (BOR) 1.3 milligram per meter square (mg/m^2) subcutaneous (SC) once weekly.
Cohort 2.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; BOR 1.3 mg/m^2 subcutaneous (SC) once weekly.
Cohort 2.3: Selinexor, Dexamethasone and Bortezomib will be dosed at RP2D-2.
Group IX: 1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd)Experimental Treatment3 Interventions
Each cycle is of 28 days
Cohort 1.1: Selinexor (SEL) 60/80/100 mg orally (PO) once weekly (QW); Dexamethasone (DEX) 40 mg PO once weekly; Pomalidomide (POM) 2/3/4 mg PO Days 1-21.
Cohort 1.2: SEL 40/60/80 mg PO twice weekly (BIW); DEX 20 mg PO twice weekly; POM 3/4 mg PO Days 1-21.
Cohort 1.3: Selinexor, Dexamethasone and Pomalidomide will be dosed at RP2D-1.
Cohort 1.4: SEL 40 mg PO QW; DEX 40 mg PO QW; POM 4mg PO once daily (QD) Days 1-21.
Group X: 12. Selinexor + dexamethasone + mezigdomide (SMd)Experimental Treatment3 Interventions
The dose of selinexor will be formally escalated from 40 mg QW to 60 mg QW in combination with mezigdomide 0.6 mg daily. Mezigdomide dosing may be de-escalated as per 3+3 criteria to 0.3 mg or escalated to 1.0 mg. The dose level that passes DLT evaluation will be considered the MTD for the cohort.
Group XI: 11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd)Experimental Treatment4 Interventions
Each Cycle is of 28 days
Cohort 11.1 SEL 40/60 mg PO once weekly on Days 1, 8, and 15; DEX total 40 mg weekly (IV or PO) single or divided doses on Days 1, 8, 15, and 22; POM 4 mg PO QW Days 1-21; DARA 16 mg/kg IV or SC QW on Days 1, 8, 15 and 22 of Cycles 1-2 and on Days 1 and 15 of Cycles 3-6, Day 1 of every Cycle greater than (>6).
Cohort 11.3 Selinexor, Dexamethasone, Pomalidomide, and Daratumumab will be dosed at RP2D-11.
Group XII: 10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd)Experimental Treatment3 Interventions
Each cycle is of 21 days
Cohort 10.1:
SEL 40/60/80 mg PO once weekly on Days 1, 8, and 15; DEX 40 mg PO QW on Days 1, 8, and 15; Belantamab Mafodotin (BEL) 2.5 mg/kg IV infusion every 3 weeks (Q3W) Day 1 of each cycle.
Cohort 10.3:
Selinexor, Dexamethasone, and Belantamab Mafodotin will be dosed at RP2D-10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
2017
Completed Phase 4
~3370
Mezigdomide
2023
Completed Phase 1
~40
Elotuzumab
2016
Completed Phase 3
~800
Belantamab Mafodotin
2021
Completed Phase 2
~10
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Bortezomib
2005
Completed Phase 2
~1140
Carfilzomib
2017
Completed Phase 3
~1440
Selinexor
2020
Completed Phase 2
~1360
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Clarithromycin
2017
Completed Phase 4
~3950
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,214 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,620 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,279 Total Patients Enrolled
22 Trials studying Multiple Myeloma
1,920 Patients Enrolled for Multiple Myeloma
Michael Kauffman, MD, Ph.DStudy DirectorKaryopharm Therapeutics Inc
4 Previous Clinical Trials
874 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with active systemic light chain amyloidosis.I haven't had blood transfusions or growth factors in the last 14 days.My multiple myeloma does not produce M-protein or light chains.I can swallow tablets and don't have issues absorbing medication.I cannot take strong CYP3A4 inhibitors due to my current medications.I have had severe nerve pain or damage in the past.I am 18 years old or older.I am experiencing complications from a stem cell transplant.My liver is functioning well, as tested within the last 28 days.I have markers for hepatitis B but no active infection.Any side effects from past treatments have mostly gone away.You are not expected to live for more than 3 months.I have symptoms from my multiple myeloma.I do not have any serious mental or physical health issues that could affect my treatment.I am eligible for treatment in Arm 6.My condition is smoldering multiple myeloma.My blood counts are within normal ranges as of the last 28 days.I am HIV positive.I am eligible for Arm 5 of the study.This criterion applies only to participants in Arm 8.Your disease can be measured using specific criteria.I have active plasma cell leukemia.I have not had major surgery in the last 4 weeks.I do not have an active infection needing IV drugs within the last week.I have previously been treated with a SINE compound like selinexor.I am eligible for Arm 10 of the study.I haven't taken strong or moderate CYP3A inhibitors/inducers in the last 7 days.I am eligible for treatment in Arm 2.I had my own stem cell transplant less than a month ago, or a donor's less than 3 months ago.I am eligible for Arm 4 of the study.My kidney function is good as tested within the last 28 days.My heart condition is currently unstable.I haven't had cancer treatment in the last 2 weeks.I am eligible for treatment in Arm 1.I have an active hepatitis A, B, or C infection.I can take care of myself but might not be able to do heavy physical work.I have a corneal condition, but it's only mild punctate keratopathy.I am a woman who can have children and my pregnancy test was negative.I am eligible for the SRd treatment in the RRMM study.I am eligible for the SRd treatment in the NDMM study.You are allergic to any of the treatments being used in the clinical trial.My myeloma has returned or didn't respond to treatment and can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: 9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd)
- Group 2: 10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd)
- Group 3: 12. Selinexor + dexamethasone + mezigdomide (SMd)
- Group 4: 1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd)
- Group 5: 5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd)
- Group 6: 8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd)
- Group 7: 4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd)
- Group 8: 2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd)
- Group 9: 6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd)
- Group 10: 7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM
- Group 11: 11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd)
- Group 12: 3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM
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 venues are conducting this experiment?
"At present, 17 clinical trial sites are recruiting patients for this medical study. These include the Jonnsson Comprehensive Cancer Center / University of Los Angeles in Los Angeles, Cross Cancer Institute / University of Alberta in Edmonton and Sarah Cannon- Tennessee Oncology Nashville in Nashville. Additionally, there are 14 other locations that have opened their doors to enrollees."
Answered by AI
How many participants are joining this clinical trial?
"To complete this trial, 518 participants that meet the qualifications need to be recruited. Locations offering enrollment include Jonnsson Comprehensive Cancer Center / University of Los Angeles in LA and Cross Cancer Institute/University of Alberta based out of Edmonton."
Answered by AI
What therapeutic benefits does Selinexor offer?
"Selinexor is typically utilized to address ophthalmic and sympathetic conditions; however, it can also be prescribed as a remedy in certain cases of branch retinal vein occlusion, macular edema, or after two prior systemic chemotherapy regimens."
Answered by AI
Are there vacant spots available in this clinical experiment for prospective participants?
"As per the details available on clinicaltrials.gov, this experiment is currently in need of volunteers. The trial was initially listed October 1st 2015 and has been most recently updated June 30th 2022."
Answered by AI
What other research endeavors have been conducted in relation to Selinexor?
"The Manitoba Blood & Marrow Transplant Program CancerCare Manitoba conducted the first study of selinexor in 2002. Since then, 1916 trials have been completed and 887 are recruiting participants with a sizeable concentration located in Los Angeles, California."
Answered by AI
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