Phase 1B / 2 Study of Selinexor in Combination With Other Treatments for Relapsed/Refractory and Newly Diagnosed Multiple Myeloma. STOMP
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What's the purpose of this trial?

The goal of this clinical trial is to determine which dose and treatment schedule of Selinexor combined with other treatments works best in the treatment of relapsed/refractory and newly diagnosed multiple myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

This is a multi-center, phase 1B (dose escalation)/phase 2 (dose expansion) study assessing how safe and effective Selinexor is in seven different combination therapies when treating relapsed/refractory and newly diagnosed multiple myeloma. Selinexor prevents your tumor suppressor proteins (TSPs), which are your cells’ natural cancer fighting proteins, from leaving the nucleus where they cannot fight a cancer cell. By Selinexor keeping your TSPs in the nucleus, it allows them to fight your cancer cells in the right place, leading to cancer cell death.

The goal of the dose escalation phase (phase 1) is to find the best dose and treatment schedule for each combination therapy. The goal of the dose expansion phase (phase 2) is to explore the doses and schedules determined in phase 1 in a larger group of participants. This trial is seeking to enroll approximately 146 - 209 patients in phase 1, and 309 patients in phase 2.

Participants in this study will receive one of seven different combination therapies. To accomplish this, this study is organized into different combination therapy groups, also called arms. Patients will be placed into an arm most appropriate for them by the study doctor depending on their diagnosis and previous treatment history.

This trial is currently recruiting for Arm 1, where participants receive an all-oral combination of Selinexor, dexamethasone and Pomalidomide.

Participants may continue to participate in the study as long as their myeloma isn’t getting worse and they aren’t experiencing bad side effects.

Selinexor + Pomalidomide + Dexamethasone (SPd): Arm 1

This arm is not accepting patients

Selinexor + Pomalidomide + Bortezomib + Dexamethasone (SPVd): Arm 4

This arm is not accepting patients

Selinexor + Carfilzomib + Dexamethasone (SKd): Arm 6

This arm is not accepting patients

Selinexor + Ixazomib + Dexamethasone (SNd): Arm 8

This arm is not accepting patients

Selinexor + Pomalidomide + Elotuzumab + Dexamethasone (SPEd): Arm 9

This arm is not accepting patients

Selinexor + Belantamab Mafodotin + Dexamethasone (SBd): Arm 10

This arm is not accepting patients

Selinexor + Pomalidomide + Daratumumab + Dexamethasone (SDPd): Arm 11

This arm is not accepting patients

Selinexor + Mezigdomide + Dexamethasone (SMd): Arm 12

This arm is accepting patients

Overview

The dose of selinexor will be formally escalated from 40 mg QW to 60 mg QW in combination with mezigdomide 0.6 mg daily. Mezigdomide dosing may be de-escalated as per 3+3 criteria to 0.3 mg or escalated to 1.0 mg. The dose level that passes DLT evaluation will be considered the MTD for the cohort.

Treatments Involved

Selinexor + Mezigdomide + Dexamethasone Learn More

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • Patients must have measurable multiple myeloma as defined by the trial criteria.
  • Depending on the arm of the trial patients join, they must meet a range of other criteria, including number of previous lines of therapy.
  • Patients must not have non-secretory multiple myeloma.
  • Patients must have adequate cardiac, liver, kidney, and bone marrow function as defined by the trial criteria.
  • Patients must not have had an autologous transplant in the one month prior to joining, or an allogeneic transplant in the three months prior to joining.

Additional Trial Information

Phase 1/2

Enrollment: 300 patients (estimated)

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Published Results

Efficacy and Safety of Selinexor, Pomalidomide, and Dexamethasone (SPd) for Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

December 07, 2024

Methods: The SPd arm of the multi-arm STOMP study evaluated selinexor at multiple doses and schedules in combination with Pd (P doses tested consisted of 2 mg, 3 mg, or 4 mg QD) in patients with RRMM. Study objectives were to determine the maximum tolerated dose and the recommended Phase 2 dose to assess safety and to examine the efficacy of the SPd regimen. Response assessments were investigator-determined per International Myeloma Working Group criteria.

The investigator-assessed overall response rate (ORR) was 39.5% (95% CI 28.8, 51.0) for the entire cohort, 55.0% (95% CI 31.5, 76.9) for SPd60, and 43.8% (95% CI 19.8, 70.1) for SPd40. The very good partial response or better rate was 19.8% (95% CI 11.7, 30.1) in the entire cohort, 30.0% (95% CI 11.9, 54.3) in SPd60, and 31.3% (95% CI 11.0, 58.7) in SPd40. There were 2 stringent complete responses (CRs; 1 in SPd60 and 1 in SPd40, both TCE) and 1 CR (SPd40). For the entire cohort, the median time to response was 1.1 months (95% CI 1.0, 2.0).

Conclusions: The all-oral combination of SPd showed signs of preliminary efficacy and was generally tolerable in patients with RRMM. Although the ORR was greater in the SPd60 cohort, TEAEs were less frequent, duration of exposure was longer, and higher dose intensity was achieved for patients treated with SPd40. These data support the further evaluation of low-dose weekly selinexor in the ongoing EMN29 trial (NCT05028348) of SPd40 versus elotuzumab and Pd in TCE RRMM progressing immediately after a αCD38-containing line of therapy.

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Open and Accepting

California

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

University of Rochester Medical Center Wilmot Cancer Center Strong Memorial Hospital

Rochester, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

Tennessee

Sarah Cannon Research Institute TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Washington

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Open and Accepting

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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