NCT02046070 · OUTCOME

Percentage of Participants With (CR + VGPR), CR, VGPR, PR, SD and PD in RRMM 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: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Day 1 of each 28-day Cycle (Up to 45 months)

What was measured

Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD 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. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas.

Analysis population: Response Evaluable Population was defined as 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.

Groups in this outcome

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

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle 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 until PD/death or unacceptable toxicity in participants with RRMM.

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 (RRMM)	73

Reported measurements

CR + VGPR

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	19	Not reported	11	30	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	5	Not reported	2	13	Not reported

VGPR

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	14	Not reported	7	24	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	44	Not reported	32	56	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	37	Not reported	26	49	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)	10	Not reported	4	19	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
11
upper Limit
30
value
19
title
CR + VGPR
categories
measurements
group Id
OG000
lower Limit
2
upper Limit
13
value
5
title
CR
categories
measurements
group Id
OG000
lower Limit
7
upper Limit
24
value
14
title
VGPR
categories
measurements
group Id
OG000
lower Limit
32
upper Limit
56
value
44
title
PR
categories
measurements
group Id
OG000
lower Limit
26
upper Limit
49
value
37
title
SD
categories
measurements
group Id
OG000
lower Limit
4
upper Limit
19
value
10
title
PD

denoms

counts
group Id
OG000
value
73
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle 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 until PD/death or unacceptable toxicity in participants with RRMM.
id
OG000
title
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

param Type

NUMBER

population Description

Response Evaluable Population was defined as 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.

reporting Status

POSTED

time Frame

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

title

Percentage of Participants With (CR + VGPR), CR, VGPR, PR, SD and PD in RRMM Participants

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice