NCT01217957 · OUTCOME

Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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: Cycles 3, 6, 9 and 12 (Up to 787 days)

What was measured

Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \< 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.

Analysis population: The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.

Groups in this outcome

Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone

In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone

In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\^2 in Phase 1.

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
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	49
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	52

Reported measurements

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	20	Not reported	10	34	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	23	Not reported	13	37	Not reported

sCR

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	6	Not reported	1	17	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	10	Not reported	3	21	Not reported

VGPR

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	39	Not reported	25	54	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	38	Not reported	25	53	Not reported

nCR

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	2	Not reported	NA	11	95% CI lower limit is \<1.
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	2	Not reported	NA	10	95% CI lower limit is \<1.

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	67	Not reported	52	80	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	65	Not reported	51	78	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	6	Not reported	1	17	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	6	Not reported	1	16	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
10
upper Limit
34
value
20
group Id
OG001
lower Limit
13
upper Limit
37
value
23
title
CR
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
17
value
6
group Id
OG001
lower Limit
3
upper Limit
21
value
10
title
sCR
categories
measurements
group Id
OG000
lower Limit
25
upper Limit
54
value
39
group Id
OG001
lower Limit
25
upper Limit
53
value
38
title
VGPR
categories
measurements
comment
95% CI lower limit is \<1.
group Id
OG000
lower Limit
NA
upper Limit
11
value
2
comment
95% CI lower limit is \<1.
group Id
OG001
lower Limit
NA
upper Limit
10
value
2
title
nCR
categories
measurements
group Id
OG000
lower Limit
52
upper Limit
80
value
67
group Id
OG001
lower Limit
51
upper Limit
78
value
65
title
PR
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
17
value
6
group Id
OG001
lower Limit
1
upper Limit
16
value
6
title
MR

denoms

counts
group Id
OG000
value
49
group Id
OG001
value
52
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG000
title
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
description
In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\^2 in Phase 1.
id
OG001
title
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone

param Type

NUMBER

population Description

The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.

reporting Status

POSTED

time Frame

Cycles 3, 6, 9 and 12 (Up to 787 days)

title

Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice