Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients
NCT04717700 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-03-18
Summary
An unrandomized phase 2 study of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group
Conditions
Interventions
- DRUG
-
Selinexor 20 MG Oral Tablet
Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
- DRUG
-
Bortezomib Injection
Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
- DRUG
-
Lenalidomide capsule
Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
- DRUG
-
Dexamethasone Oral
Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
Sponsors & Collaborators
-
Karyopharm Therapeutics Inc
collaborator INDUSTRY -
Odense Patient Data Explorative Network
collaborator OTHER -
Ida Bruun Kristensen
lead OTHER
Principal Investigators
-
Ida B Kristensen, MB · Odense University Hospital
-
Hanne Norseth, MD · Oslo University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-18
- Primary Completion
- 2025-08-01
- Completion
- 2029-06-01
- FDA Drug
- Yes
Countries
- Denmark
- Estonia
- Norway
Study Locations
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