Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03275285 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): LPLV Analysis

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients · Source last updated 2026-02-09

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
From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to 349 weeks for Kd arm and 356 weeks for IKd arm (maximum duration of treatment exposure)

What was measured

Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly/birth defect, was a medically important event.

Analysis population: Analysis was performed on safety population which included all who gave their informed consent and for whom there was confirmation of successful allocation of a randomization number by the IRT and received at least one dose or a part of a dose of the study treatments.

Groups in this outcome

Carfilzomib + Dexamethasone (Kd)

Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).

Isatuximab + Carfilzomib + Dexamethasone (IKd)

Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).

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

Analysis denominator · Participants

GroupSource count
Carfilzomib + Dexamethasone (Kd)122
Isatuximab + Carfilzomib + Dexamethasone (IKd)177

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib + Dexamethasone (Kd)119Not reportedNot reportedNot reportedNot reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)175Not reportedNot reportedNot reportedNot reported
Any treatment emergent SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib + Dexamethasone (Kd)74Not reportedNot reportedNot reportedNot reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)129Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        119
      2. group Id
        OG001
        value
        175
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        129
    title
    Any treatment emergent SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      122
    2. group Id
      OG001
      value
      177
    units
    Participants
description
Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly/birth defect, was a medically important event.
groups
  1. description
    Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).
    id
    OG000
    title
    Carfilzomib + Dexamethasone (Kd)
  2. description
    Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).
    id
    OG001
    title
    Isatuximab + Carfilzomib + Dexamethasone (IKd)
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis was performed on safety population which included all who gave their informed consent and for whom there was confirmation of successful allocation of a randomization number by the IRT and received at least one dose or a part of a dose of the study treatments.
reporting Status
POSTED
time Frame
From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to 349 weeks for Kd arm and 356 weeks for IKd arm (maximum duration of treatment exposure)
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs): LPLV Analysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice