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

Summary

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.

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

DRUG

Carfilzomib

Given IV

DRUG

Dexamethasone

Given PO

DRUG

Pomalidomide

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Selinexor

Given PO

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Prashant Kapoor, M.D. · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-06

Primary Completion

2026-05-06

Completion

2027-12-17

FDA Drug

Yes

Countries

• United States

Study Locations