A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT04414475
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Multiple Myeloma, Refractory

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Participants will receive Selinexor oral tablets.
  • Dexamethasone — DRUG
    Participants will receive Dexamethasone oral tablets.
  • Bortezomib — DRUG
    Participants will receive Bortezomib SC injection.

Study Details

The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.

Key Dates

Start date
Jul 1, 2020
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
127 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
    Participants will receive fixed dose of 40 milligram (mg) of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet twice weekly (BIW) on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle.
  • Experimental: Selinexor + Low-dose Dexamethasone (Sd-100 QW)
    Participants will receive fixed dose of 100 mg of Selinexor oral tablet followed by 40 mg of low-dose Dexamethasone oral tablet once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone may be given as 20 mg on days 1 and 2 of each week at the discretion of the treating physician).
  • Experimental: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
    Participants will receive fixed dose of 80 mg of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet BIW on Days 1, 3, 8, 10,15, 17, 22, and 24 of each 28-day cycle. Closed for recruitment.
  • Experimental: Selinexor + Bortezomib + Dexamethasone (SVd)
    Participants will receive fixed dose of 100 mg of Selinexor oral tablet on Days 1, 8, 15, 22, and 29 followed by 1.3 milligram per square-meter (mg/m\^2) of Bortezomib subcutaneous (SC) injection on Days 1, 8, 15, and 22 and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, 22, and 29 of each 35-day cycle (Dexamethasone dose may be split to 20 mg on days 1 and 2 of each week at the discretion of the treating physician). Closed for recruitment.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From the date of randomization up to death (approximately 60 months) ]

Central Contacts

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