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.

Patients are also enrolling into additional arms:

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.

Additional Trial Information

Phase 1/2

Enrollment: 437 patients (estimated)

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Trial Locations

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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

Nebraska

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Not Yet Accepting

New York

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, NY

Open and Accepting

Weill Cornell Medicine

New York, NY

Open and Accepting

University of Rochester Medical Center James P. Wilmot Cancer Center

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 TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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