NCT05032820 · OUTCOME

Efficacy of BCMA CAR-T Cell Therapy

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 6 months

What was measured

Achieving a complete response or better (CR or sCR) as assessed by the 6-month time point after BCMA CAR T-cell therapy in MM patients with suboptimal disease responses after an autologous HCT and lenalidomide maintenance.

Analysis population: Patients who received BCMA CAR T-Cell Therapy

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

Group	Source count
Lenalidomide and bb2121	38

Reported measurements

Source class 1

Acheived CR/sCR by 6 Months post Infusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	25	Not reported	Not reported	Not reported	Not reported

Did Not Acheive CR/sCR by 6 Months post Infusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	13	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
51.2
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
78.4
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
p-value is calculated using Fisher's exact test and is a one-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.
param Type
Proportion of Patients Achieving CR/sCR
param Value
65.8
statistical Comment
One-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.
statistical Method
Fisher Exact

Complete source fields

analyses

ci Lower Limit
51.2
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
78.4
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
p-value is calculated using Fisher's exact test and is a one-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.
param Type
Proportion of Patients Achieving CR/sCR
param Value
65.8
statistical Comment
One-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
value
25
title
Acheived CR/sCR by 6 Months post Infusion
measurements
group Id
OG000
value
13
title
Did Not Acheive CR/sCR by 6 Months post Infusion

denoms

counts
group Id
OG000
value
38
units
Participants

description

groups

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

COUNT_OF_PARTICIPANTS

population Description

Patients who received BCMA CAR T-Cell Therapy

reporting Status

POSTED

time Frame

6 months

title

Efficacy of BCMA CAR-T Cell Therapy

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice