Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05405166 · OUTCOME

Very Good Partial Response or Better Rate

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months

What was measured

VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, \<5% plasma cells in BM aspirates \& normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24h;\>=90% decrease in SPD compared to baseline in STP; FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.

Analysis population: The ITT population included all randomized population.

Groups in this outcome

Isa-IV + Pd

Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.

Isa-SC + Pd

Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.

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

Analysis denominator · Participants

GroupSource count
Isa-IV + Pd268
Isa-SC + Pd263

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isa-IV + Pd53.0Not reportedNot reportedNot reportedNot reported
Isa-SC + Pd50.2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.802
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.117
    estimate Comment
    Two-sided 95% CI estimated using Farrington-Manning method.
    group Description
    A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority was concluded if lower limit of relative risk 95% CI was greater or equal to 0.6312.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    <0.0001
    param Type
    Relative risk
    param Value
    0.947
    statistical Method
    Farrington-Manning
Complete source fields
analyses
  1. ci Lower Limit
    0.802
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.117
    estimate Comment
    Two-sided 95% CI estimated using Farrington-Manning method.
    group Description
    A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority was concluded if lower limit of relative risk 95% CI was greater or equal to 0.6312.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    <0.0001
    param Type
    Relative risk
    param Value
    0.947
    statistical Method
    Farrington-Manning
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        53.0
      2. group Id
        OG001
        value
        50.2
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    2. group Id
      OG001
      value
      263
    units
    Participants
description
VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, \<5% plasma cells in BM aspirates \& normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24h;\>=90% decrease in SPD compared to baseline in STP; FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    OG000
    title
    Isa-IV + Pd
  2. description
    Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    OG001
    title
    Isa-SC + Pd
param Type
NUMBER
population Description
The ITT population included all randomized population.
reporting Status
POSTED
time Frame
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
title
Very Good Partial Response or Better Rate
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice