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NCT03194867 · OUTCOME

Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients · Source last updated 2024-06-14

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
TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months

What was measured

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. SAEs were 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. TEAEs were defined as an AE which occurred after the first dose of study treatment administration up to 30 days after the last dose of study treatment administration. The DLT observation period was 1 cycle (28 days). However, all AEs during treatment, unless due to disease progression or an obviously unrelated cause, were taken into consideration by the Study Committee for the determination of the maximum tolerated dose and recommended Phase 2 dose.

Analysis population: Analysis was performed on the Safety population (tabulated according to treatment actually received \[as treated\]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.

Groups in this outcome

Phase 1: Isatuximab + CemiplimabQ2W

Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

Phase 2: Isatuximab

Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

Phase 2: Isatuximab + CemiplimabQ2W

Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

Phase 2: Isatuximab + CemiplimabQ4W

Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Isatuximab + CemiplimabQ2W3
Phase 2: Isatuximab33
Phase 2: Isatuximab + CemiplimabQ2W37
Phase 2: Isatuximab + CemiplimabQ4W35

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Isatuximab + CemiplimabQ2W3Not reportedNot reportedNot reportedNot reported
Phase 2: Isatuximab33Not reportedNot reportedNot reportedNot reported
Phase 2: Isatuximab + CemiplimabQ2W36Not reportedNot reportedNot reportedNot reported
Phase 2: Isatuximab + CemiplimabQ4W33Not reportedNot reportedNot reportedNot reported
TESAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Isatuximab + CemiplimabQ2W1Not reportedNot reportedNot reportedNot reported
Phase 2: Isatuximab17Not reportedNot reportedNot reportedNot reported
Phase 2: Isatuximab + CemiplimabQ2W17Not reportedNot reportedNot reportedNot reported
Phase 2: Isatuximab + CemiplimabQ4W21Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        36
      4. group Id
        OG003
        value
        33
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        21
    title
    TESAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      37
    4. group Id
      OG003
      value
      35
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. SAEs were 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. TEAEs were defined as an AE which occurred after the first dose of study treatment administration up to 30 days after the last dose of study treatment administration. The DLT observation period was 1 cycle (28 days). However, all AEs during treatment, unless due to disease progression or an obviously unrelated cause, were taken into consideration by the Study Committee for the determination of the maximum tolerated dose and recommended Phase 2 dose.
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    OG000
    title
    Phase 1: Isatuximab + CemiplimabQ2W
  2. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    OG001
    title
    Phase 2: Isatuximab
  3. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    OG002
    title
    Phase 2: Isatuximab + CemiplimabQ2W
  4. description
    Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    OG003
    title
    Phase 2: Isatuximab + CemiplimabQ4W
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis was performed on the Safety population (tabulated according to treatment actually received \[as treated\]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.
reporting Status
POSTED
time Frame
TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months
title
Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice