NCT01217957 · OUTCOME

Phase 2: 1 Year Survival Rate

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: 1 year after first dose of study drug

What was measured

1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.

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. 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	42
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	45

Reported measurements

Source class 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	92	Not reported	80	97	Not reported
Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone	92	Not reported	81	97	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
80
upper Limit
97
value
92
group Id
OG001
lower Limit
81
upper Limit
97
value
92

denoms

counts
group Id
OG000
value
42
group Id
OG001
value
45
units
Participants

description

1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.

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. 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

reporting Status

POSTED

time Frame

1 year after first dose of study drug

title

Phase 2: 1 Year Survival Rate

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice