A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (CARTITUDE-6) CARTITUDE-6

What's the purpose of this trial?

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

This trial is currently open and accepting patients.


What will happen during the trial?

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function.

JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT).

Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

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.

Inclusion Criteria:

  • Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
  • Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
    • Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    • Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
  • ECOG performance status of grade 0 or 1
  • Clinical laboratory values within prespecified range.

Exclusion Criteria:

  • Prior treatment with CAR-T therapy directed at any target.
  • Any prior BCMA target therapy.
  • Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
  • Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Additional Trial Information

Phase 3

Enrollment: 750 patients (estimated)

View More

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Not Yet Accepting

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Moores Cancer Center University of California UC San Diego Health

La Jolla, CA

Open and Accepting

UCSF Medical Center (Parnassus)

San Francisco, CA

Not Yet Accepting

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Not Yet Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Not Yet Accepting

Iowa

Kansas

University of Kansas Cancer Center

Kansas City, KS

Not Yet Accepting

Maryland

Massachusetts

Massachusetts General Hospital

Boston, MA

Not Yet Accepting

Dana-Farber Cancer Institute (Main)

Boston, MA

Not Yet Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Not Yet Accepting

Boston Medical Center

Boston, MA

Not Yet Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

Montefiore Medical Center

Bronx, NY

Not Yet 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

Not Yet Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting

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

Pittsburgh, PA

Not Yet Accepting

Texas

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Not Yet Accepting

Washington

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message