NCT01217957 · OUTCOME

Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)

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

What was measured

Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \< 5% plasma cells in bone marrow. VGPR is defined as 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.

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

After 3 cycles

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	35	Not reported	22	50	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	37	Not reported	24	51	Not reported

After 6 cycles

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	47	Not reported	33	62	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	48	Not reported	34	62	Not reported

After 9 cycles

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone	57	Not reported	42	71	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	58	Not reported	43	71	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
22
upper Limit
50
value
35
group Id
OG001
lower Limit
24
upper Limit
51
value
37
title
After 3 cycles
categories
measurements
group Id
OG000
lower Limit
33
upper Limit
62
value
47
group Id
OG001
lower Limit
34
upper Limit
62
value
48
title
After 6 cycles
categories
measurements
group Id
OG000
lower Limit
42
upper Limit
71
value
57
group Id
OG001
lower Limit
43
upper Limit
71
value
58
title
After 9 cycles

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

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

title

Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice