Phase 2, Open-Label Study Evaluating the Use of an Investigational CAR-T Cell therapy in Participants with Multiple Myeloma CARTITUDE-2
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What's the purpose of this trial?

This trial is evaluating the safety and efficacy of an investigational CAR-T cell medication in participants with multiple myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

This clinical trial is seeking participants who will be divided into multiple different groups (or cohorts). Cohorts are groups of participants who meet specific criteria with multiple myeloma.  Your diagnosis, past treatment history, and responses to past treatments will determine which cohort you may be eligible for. All cohorts in this trial will receive the investigational medication, with some cohorts receiving other approved therapies as well. 

This trial is currently only enrolling cohort G. All patients enrolled in cohorts G will receive induction therapy followed by treatment with an investigational CAR-T medication. Patients enrolled in Cohort G will receive four cycles of induction therapy with Daratumumab, Lenalidomide and dexamethasone. 

Treatment Involved

The investigational medication is an autologous chimeric antigen receptor T cell (CAR-T) therapy. This means it is made using your own T cells and is being evaluated to determine if it will then kill cancerous myeloma cells. In this study, some of your T cells will be removed from your blood by a process called apheresis. These T cells will then be modified in a laboratory. These T cells will then be given back to you by an intravenous infusion. The process to modify your T cells to become CAR-T cells will be explained further by a study staff member.

Before you receive the investigational medication, you will receive a conditioning regimen of chemotherapies, cyclophosphamide and fludarabine, by intravenous infusion once daily over a period of three days. 

Depending on different factors, you may be hospitalized while you receive the investigational medication and will be hospitalized for a period afterwards. 

Participants will have follow-up visits with the study team. Additionally, after the trial, participants who receive the investigational CAR-T cell medication will be followed yearly for 15 years.

You will not be paid for taking part in this study. You may receive reimbursement or stipend(s) to help with your expenses (e.g., mileage, parking, and/or meals) for attending study visits. If a caregiver is needed to accompany you to your study visits, your caregiver may receive reimbursement or stipend(s) to offset expenses (e.g. meals) for attending study visits with you. If applicable, travel assistance (e.g. car service, train, hotel arrangements) may be offered in lieu of reimbursement, to help you get to and from your study visits and to provide accommodations as necessary during your participation in the study. The study site will discuss the options that are available for you.

Importance of Diversity in clinical trials:
Research shows that certain diseases and treatments may actually impact people differently based on their age, sex, and even race – so it’s important to include a diverse range of patients in every study. Minorities tend to participate at lower rates, meaning these groups are underrepresented in this important research. 

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.

  • have measurable disease as defined by the trial criteria.
  • are newly diagnosed with myeloma and have not received (or have received very limited) prior treatment.
  • are ineligible for, or are not planning a stem cell transplant as part of initial therapy.
  • have not previously received treatment with a BCMA targeted therapy.
  • have not previously received treatment with a CAR-T cell therapy.    
  • do not have central nervous system involvement of your myeloma.
  • have adequate heart, respiratory, liver and bone marrow function as described by the trial criteria.

Additional Trial Information

Phase 2

Enrollment: 237 patients (estimated)

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Trial Links

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Moores Cancer Center University of California UC San Diego Health

La Jolla, CA

Open and Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Northside Hospital (Atlanta)

Atlanta, GA

Not Yet Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Kansas

University of Kansas Cancer Center (Westwood)

Westwood, KS

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Montefiore Medical Center

Bronx, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Not Yet Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting

Abramson Cancer Center - University of Pennsylvania (UPENN) University of Pennsylvania

Philadelphia, PA

Open and Accepting

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Virginia Commonwealth University Medical Center

Richmond, VA

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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