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NCT02046070 · OUTCOME

Number of Participants With Adverse Events (AEs), Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction and Serious Adverse Events (SAEs) in NDMM Participants

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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
First dose of study drug through 30 days after last dose of drug (Up to 45 months)

What was measured

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.

Analysis population: Safety Population was defined as all participants who receive at least 1 dose of any study drug.

Groups in this outcome

Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

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

Analysis denominator · Participants

GroupSource count
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)36
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)34

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)35Not reportedNot reportedNot reportedNot reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)34Not reportedNot reportedNot reportedNot reported
Grade 3 or Higher AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)27Not reportedNot reportedNot reportedNot reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)27Not reportedNot reportedNot reportedNot reported
AEs Resulting in Treatment Discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)9Not reportedNot reportedNot reportedNot reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)11Not reportedNot reportedNot reportedNot reported
AEs Resulting in Dose Reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)11Not reportedNot reportedNot reportedNot reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)10Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)17Not reportedNot reportedNot reportedNot reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        34
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        27
    title
    Grade 3 or Higher AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
    title
    AEs Resulting in Treatment Discontinuation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
    title
    AEs Resulting in Dose Reduction
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        20
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      34
    units
    Participants
description
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    OG000
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
  2. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    OG001
    title
    Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population was defined as all participants who receive at least 1 dose of any study drug.
reporting Status
POSTED
time Frame
First dose of study drug through 30 days after last dose of drug (Up to 45 months)
title
Number of Participants With Adverse Events (AEs), Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction and Serious Adverse Events (SAEs) in NDMM Participants
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice