Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04925193
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Multiple Myeloma in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
  • Pomalidomide — DRUG
    Oral Table
  • Daratumumab — DRUG
    Injection
  • Carfilzomib — DRUG
    Injection
  • Dexamethasone — DRUG
    Oral tablet or injection

Study Details

Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared prospectively to ex vivo drug sensitivity testing results. Participants will be enrolled and assigned into one of three treatment selection groups. The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. Selection groups are as follows: Group 1: Selinexor + pomalidomide + dexamethasone (SPd) Group 2: Selinexor + daratumumab + dexamethasone (SDd) Group 3: Selinexor + carfilzomib + dexamethasone (SKd)

Key Dates

Start date
Nov 18, 2021
Status verified
Mar 2026
Primary completion
Aug 6, 2024
Completion
Nov 30, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Treatment Options: 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 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 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

Primary Outcome Measure

Overall Response Rate [ Time Frame: End of Therapy, on average 10 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-

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By research site
University of Colorado Hospital· Aurora, CO

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