Clinical trial NCT05347485: A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
Official title: A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From Day 1 (post infusion) up to 18.6 months
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
timeFrame: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
measure: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
measure: Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity (ICANS), Other Neurotoxicities, and Secondary Primary Malignancies
timeFrame: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
measure: Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias
timeFrame: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
measure: Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Partial Response (PR) Rate
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Very Good Partial Response (VGPR) Rate
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Complete Response (CR) Rate
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Clinical Benefit Rate (CBR)
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Stringent Complete Response (sCR) Rate
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Duration of Response (DOR)
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Progression Free Survival (PFS)
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Overall Survival (OS)
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Minimal Residual Disease (MRD)-Negative Rate
timeFrame: From Day 1 (post infusion) up to 18.6 months
measure: Number of Participants With Presence of Replication Competent Lentivirus
timeFrame: Predose, 3, 6, 12 months after cilta-cel infusion on Day 1
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Westwood
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: