RecruitingPhase 2NCT06179888

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

Randomized Phase 2 Study of Iberdomide Maintenance Therapy Following Idecabtagene Vicleucel CAR-T in Multiple Myeloma Patients

Sponsor

National Cancer Institute (NCI)

Enrollment

78 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell \[CAR-T\] therapy) for multiple myeloma. The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications. There is currently no medication approved specifically for use after idecabtagene vicleucel treatment. Upon administration, iberdomide modifies the immune system and activates immune cells called T-cells, which could enhance the effectiveness of idecabtagene vicleucel. Iberdomide may keep multiple myeloma under control for longer than the usual approach (disease monitoring) after idecabtagene vicleucel, and may help multiple myeloma patients live longer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether taking a drug called iberdomide after CAR-T cell therapy for multiple myeloma (a blood cancer of plasma cells) helps keep the cancer from coming back. CAR-T therapy (ide-cel) reprograms the patient's own immune cells to attack myeloma; this trial tests whether adding iberdomide afterward extends how long the patient stays in remission. **You may be eligible if...** - You have multiple myeloma and are receiving or have received ide-cel (idecabtagene vicleucel) CAR-T cell therapy - Your cancer responded to CAR-T therapy (partial response or better) - You are in good enough health to take additional treatment - You are registered in the study prior to or shortly after CAR-T infusion **You may NOT be eligible if...** - Your cancer did not respond to CAR-T therapy - You have severe organ problems or bone marrow suppression - You are pregnant or breastfeeding - You have had prior iberdomide treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo PET/CT and/or CT

DRUGIberdomide

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPatient Monitoring

Undergo disease monitoring

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDURESkeletal Survey X-Ray

Undergo skeletal survey x-ray

Locations(74)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Augusta University Medical Center

Augusta, Georgia, United States

University of Illinois

Chicago, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, United States

Atrium Health University City/LCI-University

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Levine Cancer Institute - Huntersville

Huntersville, North Carolina, United States

Atrium Health Union/LCI-Union

Monroe, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Houston Methodist San Jacinto Hospital

Baytown, Texas, United States

Houston Methodist Cypress Hospital

Cypress, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Methodist Willowbrook Hospital

Houston, Texas, United States

Houston Methodist West Hospital

Houston, Texas, United States

Houston Methodist Saint John Hospital

Nassau Bay, Texas, United States

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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