NCT01335685 · OUTCOME

Assessments of Quality of Life (Phase 2)

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2018-01-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Baseline, Day 1 of each treatment cycle, and Day 1 of each maintenance cycle, up to 5.5 years

Analysis population: Assessments of quality of life parameters were not analyzed due to change in planned analysis.

Groups in this outcome

Arm B: Ixazomib 4.0 mg (RP2D)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).

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
Arm B: Ixazomib 4.0 mg (RP2D)	0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

denoms

counts
group Id
OG000
value
0
units
Participants

groups

description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
id
OG000
title
Arm B: Ixazomib 4.0 mg (RP2D)

population Description

Assessments of quality of life parameters were not analyzed due to change in planned analysis.

reporting Status

POSTED

time Frame

Baseline, Day 1 of each treatment cycle, and Day 1 of each maintenance cycle, up to 5.5 years

title

Assessments of Quality of Life (Phase 2)

type

SECONDARY

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

Preserved source evidence · Not medical advice