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Immunomodulatory Agent

Selinexor + Lenalidomide for Multiple Myeloma

Phase 2
Recruiting
Led By Mark Schroeder, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥18 years of age at time of enrollment
MRD-positive (per 10^-5 threshold) using clonoSEQ MRD® assay on bone marrow biopsy prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months from study treatment initiation
Awards & highlights

Study Summary

This trial tests a combo of 2 drugs to treat multiple myeloma after transplant, to see if it's more effective than just one.

Who is the study for?
Adults diagnosed with multiple myeloma who've had a stem cell transplant and are MRD-positive can join. They must have responded well to prior treatments, be in good physical condition, and have their major organs functioning properly. Pregnant or breastfeeding women, those with uncontrolled infections or heart issues, recent surgery patients, and individuals on other clinical trials cannot participate.Check my eligibility
What is being tested?
This phase II trial is testing the effectiveness of adding Selinexor to Lenalidomide for patients with multiple myeloma post-transplant. The study compares the combination treatment's efficacy against using Lenalidomide alone to see if it improves outcomes.See study design
What are the potential side effects?
Selinexor may cause nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Lenalidomide can also lead to blood clots, rash or itching skin reactions. Dexamethasone might result in mood swings, increased appetite and weight gain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My bone marrow test shows minimal residual disease.
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I have been diagnosed with multiple myeloma and have amyloid deposits in my bone marrow.
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I can take care of myself and perform daily activities.
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I am registered in the Revlimid REMS program and agree to follow its rules.
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I have been treated with a lenalidomide-based regimen.
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I had a stem cell transplant for my multiple myeloma between 80 and 140 days ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months from study treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months from study treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Minimal Residual Disease (MRD) negativity
Secondary outcome measures
Progression-free survival (PFS)
Rate of partial response or better

Trial Design

2Treatment groups
Experimental Treatment
Group I: Maintenance: Selinexor and LenalidomideExperimental Treatment2 Interventions
Maintenance will consist of selinexor and lenalidomide for a maximum of 8 28-day cycles.
Group II: Consolidation: Selinexor, Lenalidomide, and DexamethasoneExperimental Treatment3 Interventions
Consolidation will begin between Days 80 and 140 following standard of care autologous hematopoietic stem cell transplant and the treatment will consist of selinexor, lenalidomide, and dexamethasone for 4 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Lenalidomide
2005
Completed Phase 2
~1070
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,781 Total Patients Enrolled
31 Trials studying Multiple Myeloma
2,182 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
88 Previous Clinical Trials
7,604 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,185 Patients Enrolled for Multiple Myeloma
Mark Schroeder, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Multiple Myeloma
48 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05820763 — Phase 2
Multiple Myeloma Research Study Groups: Consolidation: Selinexor, Lenalidomide, and Dexamethasone, Maintenance: Selinexor and Lenalidomide
Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT05820763 — Phase 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05820763 — Phase 2
~23 spots leftby Jan 2027
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