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NCT01383928 · OUTCOME

Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2019-03-21

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
Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)

What was measured

Vital signs included body temperature, blood pressure and heart rate.

Analysis population: Safety population included all participants who received at least 1 dose of any study drug.

Groups in this outcome

Phase 1: Ixazomib 3 mg

Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).

Phase 1: Ixazomib 3.7 mg

Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).

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: Ixazomib 3 mg7
Phase 1: Ixazomib 3.7 mg7

Reported measurements

Pyrexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Ixazomib 3 mg1Not reportedNot reportedNot reportedNot reported
Phase 1: Ixazomib 3.7 mg3Not reportedNot reportedNot reportedNot reported
Bradycardia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Ixazomib 3 mg1Not reportedNot reportedNot reportedNot reported
Phase 1: Ixazomib 3.7 mg0Not reportedNot reportedNot reportedNot reported
Orthostatic hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Ixazomib 3 mg0Not reportedNot reportedNot reportedNot reported
Phase 1: Ixazomib 3.7 mg1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Ixazomib 3 mg1Not reportedNot reportedNot reportedNot reported
Phase 1: Ixazomib 3.7 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Pyrexia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Bradycardia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Orthostatic hypotension
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Hypotension
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Vital signs included body temperature, blood pressure and heart rate.
groups
  1. description
    Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
    id
    OG000
    title
    Phase 1: Ixazomib 3 mg
  2. description
    Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
    id
    OG001
    title
    Phase 1: Ixazomib 3.7 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received at least 1 dose of any study drug.
reporting Status
POSTED
time Frame
Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
title
Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice