Trial Outcomes & Findings for A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma (NCT NCT05347485)

Last Updated: 2025-04-25

Results Overview

ORR is defined as the percentage of participants who had partial response (PR) or better (sCR+CR+VGPR+PR) according to the International Myeloma Working Group (IMWG) response criteria, as assessed by the investigator. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells (PCs) in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

From Day 1 (post infusion) up to 18.6 months

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Overall Study STARTED	86
Overall Study Treated	82
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	86

Reasons for withdrawal

Reasons for withdrawal
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Overall Study Death	14
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	13
Overall Study Progressive Disease	1
Overall Study Study Terminated by Sponsor	49
Overall Study Other	1
Overall Study Enrolled (consented) but not treated	4
Overall Study Disease Relapse	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Age, Continuous	65.6 years STANDARD_DEVIATION 8.58 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment UNITED STATES	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Overall Response Rate (ORR)	57.3 Percentage of participants Interval 45.9 to 68.2

SECONDARY outcome

Timeframe: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Number of participants with TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any AE that occurred on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AE that was considered related to study intervention regardless of the start date of the event; or any AE that was present at baseline (Day 1, infusion of cilta-cel OOS) but worsens in toxicity grade or is subsequently considered related to study intervention by the investigator.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	81 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as any AE that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AE that is considered related to study intervention regardless of the start date of the event; or any AE that was present at baseline (Day 1, pre-infusion of cilta-cel OOS) but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade 1: Mild	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade 2: Moderate	6 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade 3: Severe	14 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade 4: Life-threatening	51 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade 5: Death	9 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Number of participants with serious TESAEs were reported. A SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or was an important medical event. TESAEs were defined as any SAE that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any SAE that was considered related to study intervention regardless of the start date of the event; or any SAE that was present at baseline but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	42 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Number of participants with treatment-emergent AESIs: CRS, ICANS, other neurotoxicities, and secondary primary malignancies were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. Treatment-emergent AESIs were defined as any AESI that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AESI that was considered related to study intervention regardless of the start date of the event; or any AESI that was present at baseline but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
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 Cytokine Release Syndrome (CRS)	61 Participants
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 Immune Effector Cell-Associated Neurotoxicity (ICANS)	12 Participants
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 Other neurotoxicities	8 Participants
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 Secondary primary malignancies	5 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Number of participants with treatment-emergent AESIs: prolonged and recurrent cytopenias were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. It included Thrombocytopenia, Neutropenia, Lymphopenia, and Anaemia. Treatment-emergent AESIs were defined as any AESI that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AESI that was considered related to study intervention regardless of the start date of the event; or any AESI that was present at baseline but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator. Severity was assessed using NCI-CTCAE version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Thrombocytopenia: Grade 3/4 After Day 1 Dosing	50 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Thrombocytopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30	42 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Thrombocytopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60	29 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Thrombocytopenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)	1 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Neutropenia: Grade 3/4 After Day 1 Dosing	75 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Neutropenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30	36 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Neutropenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60	18 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Neutropenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)	1 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Lymphopenia: Grade 3/4 After Day 1 Dosing	75 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Lymphopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30	32 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Lymphopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60	21 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Lymphopenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)	4 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Anaemia: Grade 3/4 After Day 1 Dosing	36 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Anaemia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30	12 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Anaemia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60	9 Participants
Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias Anaemia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)	2 Participants

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS). Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure. Here, 'n' (number analyzed) signifies number of participants analyzed for each specified categories.

Number of participants by worst grade abnormalities in clinical laboratory tests: hematology (including coagulation) and chemistry, after cilta-cel OOS infusion were reported. Grades were assessed using NCI-CTCAE (version 5.0), as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening. Participants with normal values or a value in the opposite direction (for laboratory tests with bidirectional toxicities defined) were assigned Grade 0. Only those categories in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=81 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Activated partial thromboplastin time prolonged: Grade 0	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Activated partial thromboplastin time prolonged: Grade 2	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Hemoglobin (Anemia): Grade 1	9 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Hemoglobin (Anemia): Grade 2	33 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Hemoglobin (Anemia): Grade 3	39 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Lymphocyte count decreased: Grade 0	3 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Lymphocyte count decreased: Grade 1	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Lymphocyte count decreased: Grade 2	2 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Lymphocyte count decreased: Grade 3	10 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Lymphocyte count decreased: Grade 4	65 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Neutrophil count decreased: Grade 0	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Neutrophil count decreased: Grade 1	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Neutrophil count decreased: Grade 2	4 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Neutrophil count decreased: Grade 3	21 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Neutrophil count decreased: Grade 4	54 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Platelet count decreased: Grade 0	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Platelet count decreased: Grade 1	16 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Platelet count decreased: Grade 2	14 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Platelet count decreased: Grade 3	15 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: Platelet count decreased: Grade 4	35 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: White blood cell decreased: Grade 2	4 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: White blood cell decreased: Grade 3	21 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Hematology: White blood cell decreased: Grade 4	56 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alanine Aminotransferase increased: Grade 0	53 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alanine Aminotransferase increased: Grade 1	20 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alanine Aminotransferase increased: Grade 2	5 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alanine Aminotransferase increased: Grade 3	3 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Aspartate aminotransferase increased: Grade 0	43 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Aspartate aminotransferase increased: Grade 1	28 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Aspartate aminotransferase increased: Grade 2	5 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Aspartate aminotransferase increased: Grade 3	4 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Aspartate aminotransferase increased: Grade 4	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alkaline phosphatase high: Grade 0	58 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alkaline phosphatase high: Grade 1	18 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alkaline phosphatase high: Grade 2	4 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Alkaline phosphatase high: Grade 3	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Blood bilirubin increased: Grade 0	63 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Blood bilirubin increased: Grade 1	6 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Blood bilirubin increased: Grade 2	9 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Blood bilirubin increased: Grade 3	2 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Blood bilirubin increased: Grade 4	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypercalcemia: Grade 0	76 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypercalcemia: Grade 1	4 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypercalcemia: Grade 2	1 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypocalcemia: Grade 0	36 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypocalcemia: Grade 1	23 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypocalcemia: Grade 2	19 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Hypocalcemia: Grade 4	3 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Creatinine increased: Grade 0	53 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Creatinine increased: Grade 1	16 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Creatinine increased: Grade 2	7 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Creatinine increased: Grade 3	3 Participants
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion Biochemistry: Creatinine increased: Grade 4	2 Participants

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

PR rate was defined as percentage of participants who achieved PR according to IMWG response criteria. PR was defined as per IMWG criteria as \>= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>= 90% or to \< 200 mg/24hours. If the serum and urine M-protein were unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels was required in the place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was \>=30%. In addition to the above listed criteria, if present at baseline, a \>= 50% reduction in the size of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Partial Response (PR) Rate	9.8 Percentage of Participants Interval 4.3 to 18.3

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

VGPR rate is defined as percentage of participants who achieved best response of VGPR according to IMWG response criteria. As per IMWG response criteria, VPGR: serum and urine M-component detectable by immunofixation but not on electrophoresis, or \>=90% reduction in serum M-component plus urine M-component \<100 mg/24 hours.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Very Good Partial Response (VGPR) Rate	14.6 Percentage of Participants Interval 7.8 to 24.2

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

CR rate is defined as percentage of participants who achieved best response of CR according to IMWG response criteria. CR is defined as per IMWG criteria as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. No evidence of initial monoclonal protein isotype(s) on immunofixation of the serum and urine.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Complete Response (CR) Rate	17.1 Percentage of Participants Interval 9.7 to 27.0

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Clinical benefit rate was defined as the percentage of participants who achieved a minimal response (MR) or better (including MR, PR, VGPR, CR, and sCR). MR was defined as per IMWG criteria as \>=25% but less than or equal to (\<=) 49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. In addition to the above criteria, if present at baseline, \>=50% reduction in the size of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Clinical Benefit Rate (CBR)	59.8 Percentage of Participants Interval 48.3 to 70.4

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

sCR rate is defined as percentage of participants who achieved sCR according to IMWG response criteria. sCR is defined per IMWG criteria as CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry. CR is defined as per IMWG as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. No evidence of initial monoclonal protein isotype(s) on immunofixation of the serum and urine.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Stringent Complete Response (sCR) Rate	15.9 Percentage of Participants Interval 8.7 to 25.6

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: Analysis population included responders (who achieved PR or better response) in all treated analysis set. The all treated analysis set included all participants who received study intervention (cilta-cel OOS). Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure.

DOR calculated in responders (with PR or better response) from date of initial documentation of response (PR or better) to date of first documented evidence of progressive disease (PD) as per IMWG criteria, or death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams/deciliter \[g/dL\] and \>=200 mg/24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in participants without measurable serum and/or urine M-protein levels and without measurable disease by FLC levels, bone marrow PC % (absolute increase must be \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in the size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per uL) if this was the only measure of disease.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=47 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Duration of Response (DOR)	NA Months Interval 7.75 to Median and upper limit of 95% CI could not be estimated due to low number of participants with events.

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

PFS defined as the time from the date of the initial infusion of cilta-cel OOS to the date of first documented disease progression as per IMWG criteria, or death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 g/dL and \>=200 mg/24 hours, respectively); only in participants without measurable serum and/or urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC percentage (absolute increase must be \>=10%), appearance of a new lesion; definite development of new bone lesions or definite increase in the size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per uL) if this was the only measure of disease.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Progression Free Survival (PFS)	NA Months Interval 7.39 to Median and upper limit of 95% CI could not be estimated due to low number of participants with events.

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

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 was censored at the date the participant was last known to be alive.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Overall Survival (OS)	NA Months Interval 13.67 to Median and upper limit of 95% CI could not be estimated due to low number of participants with events.

SECONDARY outcome

Timeframe: From Day 1 (post infusion) up to 18.6 months

Population: All participants who received cilta-cel OOS and had evaluable MRD samples in all treated analysis set. The all treated analysis set included all participants who received study intervention (cilta-cel OOS). Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure.

MRD-negative rate is defined as the percentage of participants with negative MRD status (at 10\^-4, 10\^-5 and 10\^-6 cutoffs) by bone marrow aspirate.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=15 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Minimal Residual Disease (MRD)-Negative Rate 10^-4 cutoff	66.7 Percentage of participants Interval 38.4 to 88.2
Minimal Residual Disease (MRD)-Negative Rate 10^-5 cutoff	66.7 Percentage of participants Interval 38.4 to 88.2
Minimal Residual Disease (MRD)-Negative Rate 10^-6 cutoff	53.3 Percentage of participants Interval 26.6 to 78.7

SECONDARY outcome

Timeframe: Predose, 3, 6, 12 months after cilta-cel infusion on Day 1

Number of participants with presence of replication competent lentivirus (with evaluable sample) were reported.

Outcome measures

Outcome measures
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=57 Participants Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Number of Participants With Presence of Replication Competent Lentivirus Predose of cilta-cel infusion	0 Participants
Number of Participants With Presence of Replication Competent Lentivirus 3 months after cilta-cel infusion	0 Participants
Number of Participants With Presence of Replication Competent Lentivirus 6 months after cilta-cel infusion	0 Participants
Number of Participants With Presence of Replication Competent Lentivirus 12 months after cilta-cel infusion	0 Participants

Adverse Events

Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)

Serious events: 42 serious events

Other events: 81 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 participants at risk Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Renal and urinary disorders Renal Tubular Necrosis	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Renal and urinary disorders Urinary Retention	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Vascular disorders Haematoma	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Vascular disorders Hypotension	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Anaemia	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Febrile Neutropenia	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Leukopenia	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Neutropenia	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Cardiac disorders Cardiac Arrest	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Endocrine disorders Adrenal Insufficiency	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
General disorders Multiple Organ Dysfunction Syndrome	2.4% 2/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
General disorders Pyrexia	2.4% 2/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Immune system disorders Cytokine Release Syndrome	23.2% 19/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Adenovirus Infection	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Clostridium Difficile Colitis	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Covid-19	2.4% 2/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Cytomegalovirus Infection	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Pneumonia	3.7% 3/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Sepsis	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Septic Embolus	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Septic Shock	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Streptococcal Bacteraemia	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Upper Respiratory Tract Infection	3.7% 3/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Urinary Tract Infection	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Liver Function Test Increased	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Musculoskeletal and connective tissue disorders Neck Pain	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Bell's Palsy	3.7% 3/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Cerebral Haemorrhage	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Haemorrhage Intracranial	2.4% 2/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Immune Effector Cell-Associated Neurotoxicity Syndrome	9.8% 8/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Neurotoxicity	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Seizure	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Psychiatric disorders Delirium	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Renal and urinary disorders Dysuria	1.2% 1/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).

Other adverse events

Other adverse events
Measure	Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) n=82 participants at risk Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.4% 11/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Hypoxia	9.8% 8/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	13.4% 11/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Vascular disorders Flushing	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Vascular disorders Hypertension	13.4% 11/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Vascular disorders Hypotension	15.9% 13/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Vascular disorders Orthostatic Hypotension	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
General disorders Fatigue	32.9% 27/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
General disorders Oedema Peripheral	12.2% 10/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
General disorders Pain	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
General disorders Pyrexia	12.2% 10/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Hepatobiliary disorders Hyperbilirubinaemia	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Immune system disorders Cytokine Release Syndrome	57.3% 47/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Immune system disorders Hypogammaglobulinaemia	13.4% 11/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Covid-19	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Respiratory, thoracic and mediastinal disorders Cough	24.4% 20/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Upper Respiratory Tract Infection	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Infections and infestations Urinary Tract Infection	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Activated Partial Thromboplastin Time Prolonged	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Alanine Aminotransferase Increased	13.4% 11/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Aspartate Aminotransferase Increased	23.2% 19/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Blood Alkaline Phosphatase Increased	9.8% 8/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Blood Creatinine Increased	12.2% 10/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Blood Fibrinogen Decreased	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Blood Lactate Dehydrogenase Increased	11.0% 9/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Investigations Gamma-Glutamyltransferase Increased	11.0% 9/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Decreased Appetite	20.7% 17/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hyperglycaemia	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hyperkalaemia	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hyperphosphataemia	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hypertriglyceridaemia	13.4% 11/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hypoalbuminaemia	12.2% 10/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hypocalcaemia	22.0% 18/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hypokalaemia	23.2% 19/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hypomagnesaemia	18.3% 15/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hyponatraemia	20.7% 17/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Metabolism and nutrition disorders Hypophosphataemia	29.3% 24/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Musculoskeletal and connective tissue disorders Arthralgia	14.6% 12/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Musculoskeletal and connective tissue disorders Back Pain	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Musculoskeletal and connective tissue disorders Muscular Weakness	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Musculoskeletal and connective tissue disorders Pain in Extremity	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Dizziness	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Headache	23.2% 19/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Immune Effector Cell-Associated Neurotoxicity Syndrome	11.0% 9/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Paraesthesia	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Nervous system disorders Tremor	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Psychiatric disorders Confusional State	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Psychiatric disorders Insomnia	17.1% 14/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Renal and urinary disorders Acute Kidney Injury	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Anaemia	59.8% 49/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Febrile Neutropenia	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Leukopenia	53.7% 44/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Lymphopenia	31.7% 26/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Neutropenia	80.5% 66/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Blood and lymphatic system disorders Thrombocytopenia	56.1% 46/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Cardiac disorders Atrial Fibrillation	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Cardiac disorders Sinus Bradycardia	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Cardiac disorders Sinus Tachycardia	12.2% 10/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Eye disorders Dry Eye	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Eye disorders Vision Blurred	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Gastrointestinal disorders Abdominal Pain	7.3% 6/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Gastrointestinal disorders Constipation	19.5% 16/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Gastrointestinal disorders Diarrhoea	30.5% 25/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Gastrointestinal disorders Nausea	31.7% 26/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Gastrointestinal disorders Stomatitis	6.1% 5/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
Gastrointestinal disorders Vomiting	8.5% 7/82 • All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100 All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).

Additional Information

Medical Director

Janssen Scientific Affairs, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER