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NCT05032820 · OUTCOME

Exploratory Objective 2: Immune Reconstitution (B-Cells, T-Cells, Monocytes, gMDSC, mMDSC)

Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma · Source last updated 2026-05-19

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

Measure
MEDIAN
Unit
% BMMC
Interval / dispersion
Standard Deviation
Time frame
Pre-LD chemo, Day 30, 90, 180, 365

What was measured

The cellular composition of marrow (B-Cells, T-Cells, Monocytes, gMDSC, mMDSC) will be quantified at the specified timepoints by flow cytometry.

Analysis population: Participants who received an infusion

Groups in this outcome

Lenalidomide and bb2121

Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis

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

Analysis denominator · Participants

GroupSource count
Lenalidomide and bb212138

Reported measurements

B cells pre-LD chemo
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21219.826.24Not reportedNot reportedNot reported
B cells Day 30
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21213.174.70Not reportedNot reportedNot reported
B cells Day 90
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21217.819.12Not reportedNot reportedNot reported
B cells Day 180
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21217.135.09Not reportedNot reportedNot reported
B cells Day 365
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21214.474.99Not reportedNot reportedNot reported
T cells pre-LD chemo
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212127.8117.43Not reportedNot reportedNot reported
T cells day 30
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212125.6817.38Not reportedNot reportedNot reported
T cells day 90
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212125.3717.75Not reportedNot reportedNot reported
T cells day 180
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212132.8416.62Not reportedNot reportedNot reported
T cells day 365
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212119.4917.16Not reportedNot reportedNot reported
Monocytes pre-LD chemo
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21219.084.31Not reportedNot reportedNot reported
Monocytes day 30
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb212113.528.21Not reportedNot reportedNot reported
Monocytes day 90
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21217.999.54Not reportedNot reportedNot reported
Monocytes day 180
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21219.355.27Not reportedNot reportedNot reported
Monocytes day 365
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21216.646.32Not reportedNot reportedNot reported
gMDSC pre-LD chemo
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.030.06Not reportedNot reportedNot reported
gMDSC day 30
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.050.13Not reportedNot reportedNot reported
gMDSC day 90
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.020.17Not reportedNot reportedNot reported
gMDSC day 180
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.050.13Not reportedNot reportedNot reported
gMDSC day 365
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.030.16Not reportedNot reportedNot reported
mMDSC pre-LD chemo
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.040.14Not reportedNot reportedNot reported
mMDSC day 30
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.070.17Not reportedNot reportedNot reported
mMDSC day 90
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.110.32Not reportedNot reportedNot reported
mMDSC day 180
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.050.18Not reportedNot reportedNot reported
mMDSC day 365
Values in % BMMC · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide and bb21210.160.20Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.24
        value
        9.82
    title
    B cells pre-LD chemo
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.70
        value
        3.17
    title
    B cells Day 30
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.12
        value
        7.81
    title
    B cells Day 90
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.09
        value
        7.13
    title
    B cells Day 180
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.99
        value
        4.47
    title
    B cells Day 365
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.43
        value
        27.81
    title
    T cells pre-LD chemo
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.38
        value
        25.68
    title
    T cells day 30
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.75
        value
        25.37
    title
    T cells day 90
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.62
        value
        32.84
    title
    T cells day 180
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.16
        value
        19.49
    title
    T cells day 365
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.31
        value
        9.08
    title
    Monocytes pre-LD chemo
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.21
        value
        13.52
    title
    Monocytes day 30
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
The cellular composition of marrow (B-Cells, T-Cells, Monocytes, gMDSC, mMDSC) will be quantified at the specified timepoints by flow cytometry.
dispersion Type
Standard Deviation
groups
  1. description
    Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
    id
    OG000
    title
    Lenalidomide and bb2121
param Type
MEDIAN
population Description
Participants who received an infusion
reporting Status
POSTED
time Frame
Pre-LD chemo, Day 30, 90, 180, 365
title
Exploratory Objective 2: Immune Reconstitution (B-Cells, T-Cells, Monocytes, gMDSC, mMDSC)
type
OTHER_PRE_SPECIFIED
unit Of Measure
% BMMC

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Preserved source evidence · Not medical advice