NCT02046070 · OUTCOME

Percentage of Participants With CR + VGR + PR (ORR), CR, VGPR, and PR in NDMM Participants Remaining on Treatment After 13 Cycles

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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Day 1 of each 28-day Cycle (Up to 45 months)

What was measured

Percentage of participants with Overall Response (CR + VGPR + PR), CR, VGPR and PR according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;\<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component \<100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or \<200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas.

Analysis population: Participants from the Response Evaluable Population, participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline and at least 1 postbaseline response assessment, with both an Induction and Maintenance response.

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

Group	Source count
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)	24
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)	21

Reported measurements

CR + VGPR + PR

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)	75.0	Not reported	Not reported	Not reported	Not reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)	85.7	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)	16.7	Not reported	Not reported	Not reported	Not reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)	19.0	Not reported	Not reported	Not reported	Not reported

VGPR

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)	20.8	Not reported	Not reported	Not reported	Not reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)	28.6	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)	37.5	Not reported	Not reported	Not reported	Not reported
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)	38.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
75.0
group Id
OG001
value
85.7
title
CR + VGPR + PR
categories
measurements
group Id
OG000
value
16.7
group Id
OG001
value
19.0
title
CR
categories
measurements
group Id
OG000
value
20.8
group Id
OG001
value
28.6
title
VGPR
categories
measurements
group Id
OG000
value
37.5
group Id
OG001
value
38.1
title
PR

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
21
units
Participants

description

groups

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)
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

NUMBER

population Description

Participants from the Response Evaluable Population, participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline and at least 1 postbaseline response assessment, with both an Induction and Maintenance response.

reporting Status

POSTED

time Frame

Day 1 of each 28-day Cycle (Up to 45 months)

title

Percentage of Participants With CR + VGR + PR (ORR), CR, VGPR, and PR in NDMM Participants Remaining on Treatment After 13 Cycles

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice