NCT05347485 · OUTCOME
Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma · Source last updated 2025-04-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure COUNT_OF_PARTICIPANTS
Unit Participants
Interval / dispersion Not reported
Time frame From Day 1 (post infusion) up to 18.6 months What was measured 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.
Analysis 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.
Groups in this outcome 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Reported measurements Hematology: Activated partial thromboplastin time prolonged: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 2
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Hematology: Activated partial thromboplastin time prolonged: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 2
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Hematology: Hemoglobin (Anemia): Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 9 Not reported Not reported Not reported Not reported
Hematology: Hemoglobin (Anemia): Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 33 Not reported Not reported Not reported Not reported
Hematology: Hemoglobin (Anemia): Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 39 Not reported Not reported Not reported Not reported
Hematology: Lymphocyte count decreased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 3 Not reported Not reported Not reported Not reported
Hematology: Lymphocyte count decreased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Hematology: Lymphocyte count decreased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 2 Not reported Not reported Not reported Not reported
Hematology: Lymphocyte count decreased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 10 Not reported Not reported Not reported Not reported
Hematology: Lymphocyte count decreased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 65 Not reported Not reported Not reported Not reported
Hematology: Neutrophil count decreased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Hematology: Neutrophil count decreased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Hematology: Neutrophil count decreased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 4 Not reported Not reported Not reported Not reported
Hematology: Neutrophil count decreased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 21 Not reported Not reported Not reported Not reported
Hematology: Neutrophil count decreased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 54 Not reported Not reported Not reported Not reported
Hematology: Platelet count decreased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Hematology: Platelet count decreased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 16 Not reported Not reported Not reported Not reported
Hematology: Platelet count decreased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 14 Not reported Not reported Not reported Not reported
Hematology: Platelet count decreased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 15 Not reported Not reported Not reported Not reported
Hematology: Platelet count decreased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 35 Not reported Not reported Not reported Not reported
Hematology: White blood cell decreased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 4 Not reported Not reported Not reported Not reported
Hematology: White blood cell decreased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 21 Not reported Not reported Not reported Not reported
Hematology: White blood cell decreased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 56 Not reported Not reported Not reported Not reported
Biochemistry: Alanine Aminotransferase increased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 53 Not reported Not reported Not reported Not reported
Biochemistry: Alanine Aminotransferase increased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 20 Not reported Not reported Not reported Not reported
Biochemistry: Alanine Aminotransferase increased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 5 Not reported Not reported Not reported Not reported
Biochemistry: Alanine Aminotransferase increased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 3 Not reported Not reported Not reported Not reported
Biochemistry: Aspartate aminotransferase increased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 43 Not reported Not reported Not reported Not reported
Biochemistry: Aspartate aminotransferase increased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 28 Not reported Not reported Not reported Not reported
Biochemistry: Aspartate aminotransferase increased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 5 Not reported Not reported Not reported Not reported
Biochemistry: Aspartate aminotransferase increased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 4 Not reported Not reported Not reported Not reported
Biochemistry: Aspartate aminotransferase increased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Biochemistry: Alkaline phosphatase high: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 58 Not reported Not reported Not reported Not reported
Biochemistry: Alkaline phosphatase high: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 18 Not reported Not reported Not reported Not reported
Biochemistry: Alkaline phosphatase high: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 4 Not reported Not reported Not reported Not reported
Biochemistry: Alkaline phosphatase high: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Biochemistry: Blood bilirubin increased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 63 Not reported Not reported Not reported Not reported
Biochemistry: Blood bilirubin increased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 6 Not reported Not reported Not reported Not reported
Biochemistry: Blood bilirubin increased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 9 Not reported Not reported Not reported Not reported
Biochemistry: Blood bilirubin increased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 2 Not reported Not reported Not reported Not reported
Biochemistry: Blood bilirubin increased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Biochemistry: Hypercalcemia: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 76 Not reported Not reported Not reported Not reported
Biochemistry: Hypercalcemia: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 4 Not reported Not reported Not reported Not reported
Biochemistry: Hypercalcemia: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 1 Not reported Not reported Not reported Not reported
Biochemistry: Hypocalcemia: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 36 Not reported Not reported Not reported Not reported
Biochemistry: Hypocalcemia: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 23 Not reported Not reported Not reported Not reported
Biochemistry: Hypocalcemia: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 19 Not reported Not reported Not reported Not reported
Biochemistry: Hypocalcemia: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 3 Not reported Not reported Not reported Not reported
Biochemistry: Creatinine increased: Grade 0 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 53 Not reported Not reported Not reported Not reported
Biochemistry: Creatinine increased: Grade 1 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 16 Not reported Not reported Not reported Not reported
Biochemistry: Creatinine increased: Grade 2 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 7 Not reported Not reported Not reported Not reported
Biochemistry: Creatinine increased: Grade 3 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 3 Not reported Not reported Not reported Not reported
Biochemistry: Creatinine increased: Grade 4 Analysis denominator · Participants
Group Source count Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 81
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) 2 Not reported Not reported Not reported Not reported
Complete source fields classes
title Hematology: Activated partial thromboplastin time prolonged: Grade 0
title Hematology: Activated partial thromboplastin time prolonged: Grade 2
title Hematology: Hemoglobin (Anemia): Grade 1
title Hematology: Hemoglobin (Anemia): Grade 2
title Hematology: Hemoglobin (Anemia): Grade 3
title Hematology: Lymphocyte count decreased: Grade 0
title Hematology: Lymphocyte count decreased: Grade 1
title Hematology: Lymphocyte count decreased: Grade 2
title Hematology: Lymphocyte count decreased: Grade 3
title Hematology: Lymphocyte count decreased: Grade 4
title Hematology: Neutrophil count decreased: Grade 0
title Hematology: Neutrophil count decreased: Grade 1 Show more (12 of 53)
description 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. groups
description 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.
id OG000
title Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)
param Type COUNT_OF_PARTICIPANTS
population Description 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.
reporting Status POSTED
time Frame From Day 1 (post infusion) up to 18.6 months
title Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion
type SECONDARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle