Phase 3, Randomized Study comparing Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by an investigational CAR-T versus VRd followed by Lenalidomide and Dexamethasone (RD)Therapy in subjects with newly diagnosed Multiple Myeloma for whom Stem Cell Transplant is not planned as initial therapy CARTITUDE-5
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What's the purpose of this trial?

This trial is comparing the safety and efficacy of VRd followed by an investigational CAR-T cell therapy versus VRd and Rd in participants with newly diagnosed multiple myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

This trial is seeking approximately 650 participants, who will be randomly assigned into one of two different groups (or cohorts). Cohorts are groups of participants who meet specific criteria for Multiple Myeloma. Before being separated into different arms (randomization), all participants in the study will receive 5-6 cycles of Bortezomib, Lenalidomide, and Dexamethasone (VRd). Participants will need to visit the study site four times during each 21 day cycle. 

During these initial cycles before being placed into different groups, participants will receive:

  • Bortezomib, given by subcutaneous injection, every three days during the first half of each cycle.
  • Lenalidomide, given by mouth daily, for the first two weeks of each cycle.
  • Dexamethasone, given by mouth during the first two weeks of each cycle.

Treatment Involved

The investigational medication is an investigational autologous chimeric antigen receptor T cell (CAR-T) therapy. This means it’s a therapy made from your own T cells, to try and kill your cancerous multiple myeloma cells. In this study, your doctor will draw whole blood and separate it into its parts- plasma and white blood cells (T-cells). This process is called apheresis.  These T cells will then be changed in a laboratory by giving them some new genetic material. These T cells will then be given back to you by an intravenous infusion.

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. Janssen is committed to Health Equity. Once assigned to a study site, please inquire about financial programs in place to support clinical trial participation.

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 described in the trial protocol.
  • 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.
  • do not have central nervous system involvement of your myeloma.
  • have not had prior treatment with a CAR-T cell therapy.
  • have adequate heart, respiratory, liver, and bone marrow function as described by the trial criteria.     

Additional Trial Information

Phase 3

Enrollment: 650 patients (estimated)

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Trial Locations

All Trial Locations

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Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Open and Accepting

Florida

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

AdventHealth - Blood & Marrow Transplant Center (East Orlando)

Orlando, FL

Open and Accepting

Iowa

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

Iowa City, IA

Open and Accepting

Kentucky

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

Louisville, KY

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Massachusetts

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Henry Ford Hospital

Detroit, MI

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Open and Accepting

North Carolina

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

Charlotte, NC

Open and Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting

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

Pittsburgh, PA

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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