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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05347485
Other study ID # CR109014
Secondary ID 68284528MMY2005
Status Completed
Phase Phase 2
First received
Last updated
Start date May 13, 2022
Est. completion date January 16, 2024

Study information

Verified date February 2024
Source Janssen Scientific Affairs, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date January 16, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Cilta-cel
Cilta-cel will be administered as an IV infusion.
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Levine Cancer Institute Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States Colorado Blood Cancer Institute Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States City of Hope Duarte California
United States Hackensack University Medical Center Hackensack New Jersey
United States MD Anderson Cancer Center Houston Texas
United States Medical College Of Wisconsin Milwaukee Wisconsin
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Medical Center New York New York
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States University of California San Francisco San Francisco California
United States Stanford University Medical Center Stanford California
United States Kansas University Medical Center Westwood Kansas

Sponsors (1)

Lead Sponsor Collaborator
Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate (ORR) ORR is defined as percentage of participants who achieve partial response or better according to international myeloma working group (IMWG) response criteria. Screening Phase through End of Study (EOS) (Up to 4 years)
Secondary Number of Participants with Treatment-emergent Adverse Events (TEAEs) Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment. Up to 4 years
Secondary Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. Up to 4 years
Secondary Number of Participants with Serious Adverse Events (SAEs) SAE is any untoward medical occurrence that results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Up to 4 years
Secondary Number of Participants with Adverse Events of Special Interest (AESIs) Number of participants with AESI will be reported. Cytokine release syndrome, neurotoxicity, prolonged and recurrent cytopenias, and second primary malignancies will be considered to be AESIs. Up to 4 years
Secondary Number of Participants with Clinically Significant Abnormalities in Safety Laboratory Tests Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology, infectious diseases testing, and urinalysis) will be reported. Up to 4 years
Secondary Number of Participants with Clinically Significant Abnormalities in Vital Signs Number of participants with clinically significant abnormalities in vital signs (including temperature, pulse/heart rate, respiratory rate, oxygen saturation, and blood pressure) will be reported. Up to 4 years
Secondary Number of Participants with Clinically Significant Abnormalities in Physical Examination Number of participants with clinically significant abnormalities in physical examination will be reported. Up to 4 years
Secondary Partial Response (PR) Rate PR rate is defined as percentage of participants who achieve PR according to IMWG response criteria. Up to 4 years
Secondary Very Good Partial Response (VGPR) Rate VGPR rate is defined as percentage of participants who achieve VGPR according to IMWG response criteria. Up to 4 years
Secondary Complete Response (CR) Rate CR rate is defined as percentage of participants who achieve CR according to IMWG response criteria. Up to 4 years
Secondary Stringent Complete Response (sCR) Rate sCR rate is defined as percentage of participants who achieve sCR according to IMWG response criteria. Up to 4 years
Secondary Clinical Benefit Rate (CBR) CBR (CBR=ORR [sCR+CR+VGPR+PR]+minimal response [MR]) is defined as percentage of participants who achieve CBR according to IMWG response criteria. Up to 4 years
Secondary Duration of Response (DOR) DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG response criteria. Up to 4 years
Secondary Progression Free Survival (PFS) PFS defined as the time from the date of the initial infusion of cilta-cel out-of-specification (OOS) to the date of first documented disease progression, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first. Up to 4 years
Secondary Overall Survival (OS) OS is measured from the date of the initial infusion of cilta-cel OOS to the date of the participant's death. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive. Up to 4 years
Secondary Minimal Residual Disease (MRD) Negative Rate MRD negative rate is defined as the percentage of participants in CR with negative MRD status. Up to 4 years
Secondary Number of Participants with Presence of Replication Competent Lentivirus Number of participants with presence of replication competent lentivirus will be reported. Up to 4 years
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