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NCT03318861 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From KITE-585 infusion to date of data cutoff (maximum: 17.6 months)

What was measured

Overall survival is defined as the time from the first dose date of study drug to the date of death from any cause. Analysis was done using KM estimate. Participants who have not died by the analysis data cutoff date were censored at their last date known to be alive or cutoff date, whichever is earlier.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Escalation: 3 x 10^7 KITE-585NANot reported11.1NAMedian and upper limit of CI were not estimable due to insufficient number of events.
Dose Escalation: 1 x 10^8 KITE-5855.1Not reported3.0NAUpper limit of CI was not estimable due to insufficient number of events.
Dose Escalation: 3 x 10^8 KITE-5856.9Not reported3.2NAUpper limit of CI was not estimable due to insufficient number of events.
Dose Escalation: 1 x 10^9 KITE-585NANot reported5.5NAMedian and upper limit of CI were not estimable due to insufficient number of events.
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-58512.2Not reportedNANALower and upper limit of CI were not estimable due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of CI were not estimable due to insufficient number of events.
        group Id
        OG000
        lower Limit
        11.1
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit of CI was not estimable due to insufficient number of events.
        group Id
        OG001
        lower Limit
        3.0
        upper Limit
        NA
        value
        5.1
      3. comment
        Upper limit of CI was not estimable due to insufficient number of events.
        group Id
        OG002
        lower Limit
        3.2
        upper Limit
        NA
        value
        6.9
      4. comment
        Median and upper limit of CI were not estimable due to insufficient number of events.
        group Id
        OG003
        lower Limit
        5.5
        upper Limit
        NA
        value
        NA
      5. comment
        Lower and upper limit of CI were not estimable due to insufficient number of events.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        12.2
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
Overall survival is defined as the time from the first dose date of study drug to the date of death from any cause. Analysis was done using KM estimate. Participants who have not died by the analysis data cutoff date were censored at their last date known to be alive or cutoff date, whichever is earlier.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Participants in the Safety Analysis Set were analyzed.
reporting Status
POSTED
time Frame
From KITE-585 infusion to date of data cutoff (maximum: 17.6 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice