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

Multiple Myeloma Clinical Trial

Official title:

A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347485
• Other study ID #: CR109014
• Secondary ID: 68284528MMY2005
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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