Multiple Myeloma Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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 during screening 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

330

Study ID:

NCT05347485

Recruitment Status:

Recruiting

Sponsor:

Janssen Scientific Affairs, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 23 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
University of California, San Francisco
San Francisco California, 94143, United States
Stanford University Medical Center
Stanford California, 94305, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
University of Miami
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Emory University
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Kansas University Medical Center
Westwood Kansas, 66205, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Washington-Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

330

Study ID:

NCT05347485

Recruitment Status:

Recruiting

Sponsor:


Janssen Scientific Affairs, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.