Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Natalie Callander
Study ID
NCT07479979
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Refractory Multiple Myeloma
  • Relapse Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Phase I: Selinexor at assigned dose by mouth begin Day 1, 8, 15, and 22 until study treatment stop. - Dose Levels: -1: 20mg weekly 0 (Starting Dose): 40mg weekly 1: 60mg weekly Phase II: Selinexor at assigned dose by mouth based on the phase 1 findings. Selinexor will be taken weekly (Days 1, 8, 15, and 22).
  • Carfilzomib — DRUG
    Phase I and Phase II: Carfilzomib IV will be administered on Day 1, 8, and 15. The first dose of carfilzomib will be carfilzomib 20mg/m2 IV. Every dose after will be carfilzomib 56mg/m2.
  • Isatuximab — DRUG
    Phase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15.
  • Isatuximab SC Wearable Injection System — DEVICE
    Phase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15.
  • Dexamethasone — DRUG
    Phase I and Phase II: Dexamethasone 40mg will be administered either by IV or orally on Days 1, 8, 15, and 22.

Study Details

The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
62 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone
    Participants will receive selinexor at their assigned dose taken orally on a 28-day cycle combined with carfilzomib, isatuximab, and dexamethasone IV administered on a 28-day cycle until disease progression or for an unacceptable toxicity.
  • Experimental: Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone
    Participants will receive selinexor at their assigned dose taken orally on a 28-day cycle combined with carfilzomib, isatuximab, and dexamethasone IV administered on a 28-day cycle until disease progression or for an unacceptable toxicity.

Primary Outcome Measure

Adverse Events [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Beth Moore
[email protected]
608-262-5189

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By research site
University of Wisconsin· Madison, WI

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