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NCT03318861 · OUTCOME

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2023-10-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From KITE-585 infusion until 28 days after KITE-585 infusion

What was measured

A DLT is a KITE-585-related event with onset in the first 28 days following infusion. DLTs are defined by events and duration of events, including: * Any duration: Grade (GR) 4 cytokine release syndrome (CRS), KITE-585-related GR 5 adverse events (AE) and GR 4 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 3 or better in ≤ 72 hours, hypogammaglobulinemia, tumor lysis syndrome, acute renal toxicity requiring dialysis for ≤ 7 days, intubation for airway protection for ≤ 7 days and AE resolves to ≤ GR 1 within 2 weeks and baseline within 4 weeks * ≥ 72 hours: GR 3 CRS and GR 3 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 2 or better in ≤ 14 days, hypogammaglobulinemia and tumor lysis syndrome * ≥ 30 days: GR 4 hematologic AE with the exceptions of cytopenias attributable to ongoing or recurrent multiple myeloma

Analysis population: DLT Evaluable Set included participants in the dose escalation period who received the target dose (± 20%) and were followed for at least 28 days after the first KITE-585 infusion; or received a dose of KITE-585 lower than 20% below the target dose for that cohort and experienced a DLT during the 28-day post-first-infusion period.

Groups in this outcome

Dose Escalation: 3 x 10^7 KITE-585

Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.

Dose Escalation: 1 x 10^8 KITE-585

Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.

Dose Escalation: 3 x 10^8 KITE-585

Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.

Dose Escalation: 1 x 10^9 KITE-585

Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation: 3 x 10^7 KITE-5853
Dose Escalation: 1 x 10^8 KITE-5854
Dose Escalation: 3 x 10^8 KITE-5853
Dose Escalation: 1 x 10^9 KITE-5854

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: 3 x 10^7 KITE-5850Not reportedNot reportedNot reportedNot reported
Dose Escalation: 1 x 10^8 KITE-5850Not reportedNot reportedNot reportedNot reported
Dose Escalation: 3 x 10^8 KITE-5850Not reportedNot reportedNot reportedNot reported
Dose Escalation: 1 x 10^9 KITE-5850Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    units
    Participants
description
A DLT is a KITE-585-related event with onset in the first 28 days following infusion. DLTs are defined by events and duration of events, including: * Any duration: Grade (GR) 4 cytokine release syndrome (CRS), KITE-585-related GR 5 adverse events (AE) and GR 4 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 3 or better in ≤ 72 hours, hypogammaglobulinemia, tumor lysis syndrome, acute renal toxicity requiring dialysis for ≤ 7 days, intubation for airway protection for ≤ 7 days and AE resolves to ≤ GR 1 within 2 weeks and baseline within 4 weeks * ≥ 72 hours: GR 3 CRS and GR 3 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 2 or better in ≤ 14 days, hypogammaglobulinemia and tumor lysis syndrome * ≥ 30 days: GR 4 hematologic AE with the exceptions of cytopenias attributable to ongoing or recurrent multiple myeloma
groups
  1. description
    Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
    id
    OG000
    title
    Dose Escalation: 3 x 10^7 KITE-585
  2. description
    Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
    id
    OG001
    title
    Dose Escalation: 1 x 10^8 KITE-585
  3. description
    Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^8 autologous anti-BCMA CAR T cells on Day 0.
    id
    OG002
    title
    Dose Escalation: 3 x 10^8 KITE-585
  4. description
    Participants with RRMM, received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^9 autologous anti-BCMA CAR T cells on Day 0.
    id
    OG003
    title
    Dose Escalation: 1 x 10^9 KITE-585
param Type
NUMBER
population Description
DLT Evaluable Set included participants in the dose escalation period who received the target dose (± 20%) and were followed for at least 28 days after the first KITE-585 infusion; or received a dose of KITE-585 lower than 20% below the target dose for that cohort and experienced a DLT during the 28-day post-first-infusion period.
reporting Status
POSTED
time Frame
From KITE-585 infusion until 28 days after KITE-585 infusion
title
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice