Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04764942
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given PO
  • Pomalidomide — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Selinexor — DRUG
    Given PO
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray imaging
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase I/II trial identifies the best dose and side effects of selinexor, and how well it works when given in combination with pomalidomide and dexamethasone with or without carfilzomib in treating patients with multiple myeloma that has come back (relapsed) and does not respond to treatment with proteasome inhibitors and immunomodulatory drugs (refractory). Selinexor is an oral agent that blocks a protein called Exportin 1 (XPO1 or CRM1) that is abundant in a wide variety of cancers, including multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pomalidomide may stop the growth of blood vessels, stimulate the immune system, and kill cancer cells. Anti-inflammatory drugs, such as dexamethasone may lower the body's immune response and are used with other drugs in the treatment of some types of cancer. The addition of selinexor may allow better control of relapsed refractory multiple myeloma than is possible with pomalidomide and dexamethasone with or without carfilzomib.

Key Dates

Start date
May 6, 2021
Status verified
Feb 2026
Primary completion
May 6, 2026
Completion
Dec 17, 2027

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (selinexor, dexamethasone, carfilzomib, carfilzomib)
    Patients receive selinexor PO and dexamethasone PO on days 1, 8 15, and 22, carfilzomib IV on days 1, 8, and 15, and pomalidomide PO on days 1-21. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT and bone marrow biopsy and aspiration during screening and on the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
  • Experimental: Arm B (selinexor, dexamethasone, pomalidomide)
    Patients receive selinexor PO and dexamethasone PO on days 1, 8, 15, and 22, and pomalidomide PO on days 1-21. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT and bone marrow biopsy and aspiration during screening and on the trial. Patients may optionally undergo blood sample collection during screening and on the trial.

Primary Outcome Measure

Maximum tolerated dose of selinexor in combination with carfilzomib, pomalidomide and dexamethasone (Phase I) [ Time Frame: Up to 30 days after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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