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NCT05405166 · OUTCOME

Overall Response Rate (ORR)

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 PCD (06-Nov-2024), approximately 28 months

What was measured

ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.

Analysis population: The intent-to-treat (ITT) population included all randomized population (all participants who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number by the interactive response technology \[IRT\]). Percentages are rounded off to the tenth decimal place.

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 + Pd70.5Not reportedNot reportedNot reportedNot reported
Isa-SC + Pd71.1Not 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
    0.903
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.126
    estimate Comment
    Two-sided 95% CI estimated using Farrington-Manning method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority was concluded if lower limit of relative risk 95% confidence interval (CI) was greater or equal to 0.839.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.0006
    param Type
    Relative risk
    param Value
    1.008
    statistical Method
    Farrington-Manning
Complete source fields
analyses
  1. ci Lower Limit
    0.903
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.126
    estimate Comment
    Two-sided 95% CI estimated using Farrington-Manning method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority was concluded if lower limit of relative risk 95% confidence interval (CI) was greater or equal to 0.839.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.0006
    param Type
    Relative risk
    param Value
    1.008
    statistical Method
    Farrington-Manning
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        70.5
      2. group Id
        OG001
        value
        71.1
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    2. group Id
      OG001
      value
      263
    units
    Participants
description
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.
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 intent-to-treat (ITT) population included all randomized population (all participants who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number by the interactive response technology \[IRT\]). Percentages are rounded off to the tenth decimal place.
reporting Status
POSTED
time Frame
From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice