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NCT03318861 · OUTCOME

Duration of Response (DOR) as Determined by Study Investigators According to the IMWG Consensus Panel 1

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
months
Interval / dispersion
Not reported
Time frame
From first response to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)

What was measured

DOR is defined for participants who experience an objective response and is defined as the time from the date of their first objective response (which is subsequently confirmed) to PD per IMWG Consensus Panel 1 Criteria or death from any cause, whichever is earlier. Objective response is defined in Outcome measure 2.

Analysis population: Participants in the Safety Analysis Set who achieved a stringent CR (sCR), complete response (CR), partial response (PR), or very good PR (VGPR), as determined by IMWG Consensus Panel 1 Criteria were to be analyzed. As per changes in planned analysis, this outcome measure could not be analyzed at the data cutoff date due to an insufficient number of responders. Kite/Gilead did not collect the DOR data after the data cutoff date.

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-5851
Dose Escalation: 1 x 10^8 KITE-5850
Dose Escalation: 3 x 10^8 KITE-5850
Dose Escalation: 1 x 10^9 KITE-5850
Dose Expansion (Renal Impairment): 3 x 10^7 KITE-5850

Reported measurements

Source class 1
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: 3 x 10^7 KITE-585NANot reportedNot reportedNot reportedDue to an insufficient number of responders, this endpoint was not analyzed.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Due to an insufficient number of responders, this endpoint was not analyzed.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    units
    Participants
description
DOR is defined for participants who experience an objective response and is defined as the time from the date of their first objective response (which is subsequently confirmed) to PD per IMWG Consensus Panel 1 Criteria or death from any cause, whichever is earlier. Objective response is defined in Outcome measure 2.
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 who achieved a stringent CR (sCR), complete response (CR), partial response (PR), or very good PR (VGPR), as determined by IMWG Consensus Panel 1 Criteria were to be analyzed. As per changes in planned analysis, this outcome measure could not be analyzed at the data cutoff date due to an insufficient number of responders. Kite/Gilead did not collect the DOR data after the data cutoff date.
reporting Status
POSTED
time Frame
From first response to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
title
Duration of Response (DOR) as Determined by Study Investigators According to the IMWG Consensus Panel 1
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice