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NCT03318861 · OUTCOME

Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

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
Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)

What was measured

Clinically significant laboratory abnormalities were defined as per investigator's discretion.

Analysis population: Participants in the Safety Analysis Set were analyzed.

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.

Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585

RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 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-5853
Dose Escalation: 3 x 10^8 KITE-5853
Dose Escalation: 1 x 10^9 KITE-5853
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-5852

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
Dose Expansion (Renal Impairment): 3 x 10^7 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
      5. group Id
        OG004
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      2
    units
    Participants
description
Clinically significant laboratory abnormalities were defined as per investigator's discretion.
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
  5. description
    RRMM participants with moderate renal impairment (creatinine clearance 30 to 59 mL/min \[Grade 2 chronic kidney disease\]) received conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 24 mg/m\^2/day IV infusion for 3 days followed by single infusion of KITE-585 at a tolerable dose of 3 x 10\^7 autologous anti-BCMA CAR T cells on Day 0.
    id
    OG004
    title
    Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585
param Type
NUMBER
population Description
Participants in the Safety Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)
title
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice