A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

What's the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

This trial is currently open and accepting patients.

What will happen during the trial?

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:

  • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
  • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
  • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
  • Meets the criteria to receive lymphodepleting chemotherapy
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

  • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
  • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
  • Hepatitis B infection
  • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
  • Seropositive for human immunodeficiency virus (HIV)
  • Uncontrolled autoimmune disease

Additional Trial Information

Phase 2

Enrollment: 330 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Stanford Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting



Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting


Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting


Massachusetts General Hospital

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Not Yet Accepting


Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting


Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting


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

Pittsburgh, PA

Open and Accepting


MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting


Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
Interested in this trial?
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