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NCT03958656 · OUTCOME

Number of Participants With a Response

T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma · Source last updated 2021-09-09

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
At two and five weeks for stable disease and partial remission, respectively, and up to 5 months and 23 days for progressive disease

What was measured

Response was assessed by the International Uniform Response Criteria for Multiple myeloma 2016 updated version. Complete Remission (CR) is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis, or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 h. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200mg per 24 h). Progressive Disease (PD) is serum M-component (minimum absolute increase of 0.5g/dL), or urine M-component (minimum absolute increase of 200mg/24h). Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or progressive disease.

Analysis population: 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated. No weeks are necessary for PD.

Groups in this outcome

LEVEL 1 - 0.66x10^6 Per Kilogram (kg)

0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

LEVEL 2 - 2.0x10^6 Per kg

2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

LEVEL 3 - 6.0x10^6 Per kg

6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

LEVEL 4 - 12.0x10^6 Per kg

12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

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

Analysis denominator · Participants

GroupSource count
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)3
LEVEL 2 - 2.0x10^6 Per kg3
LEVEL 3 - 6.0x10^6 Per kg3
LEVEL 4 - 12.0x10^6 Per kg1

Reported measurements

Partial Remission at 5 Weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)0Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
Stable Disease at 2 Weeks
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)2Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg2Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)1Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Partial Remission at 5 Weeks
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
    title
    Stable Disease at 2 Weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Progressive Disease
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
      1
    units
    Participants
description
Response was assessed by the International Uniform Response Criteria for Multiple myeloma 2016 updated version. Complete Remission (CR) is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis, or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 h. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200mg per 24 h). Progressive Disease (PD) is serum M-component (minimum absolute increase of 0.5g/dL), or urine M-component (minimum absolute increase of 200mg/24h). Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or progressive disease.
groups
  1. description
    0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG000
    title
    LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
  2. description
    2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG001
    title
    LEVEL 2 - 2.0x10^6 Per kg
  3. description
    6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG002
    title
    LEVEL 3 - 6.0x10^6 Per kg
  4. description
    12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG003
    title
    LEVEL 4 - 12.0x10^6 Per kg
param Type
COUNT_OF_PARTICIPANTS
population Description
3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated. No weeks are necessary for PD.
reporting Status
POSTED
time Frame
At two and five weeks for stable disease and partial remission, respectively, and up to 5 months and 23 days for progressive disease
title
Number of Participants With a Response
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice