NCT00405756 · OUTCOME

Time to First Response

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older. · Source last updated 2017-01-11

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

Measure: MEAN
Unit: weeks
Interval / dispersion: Standard Deviation
Time frame: Up to 66 weeks

What was measured

Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.

Analysis population: Participants who had a partial response (PR) or complete response (CR)

Groups in this outcome

MPR+R

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPR+p

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPp+p

Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

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
MPR+R	117
MPR+p	104
MPp+p	77

Reported measurements

Source class 1

Values in weeks · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
MPR+R	10.0	7.40	Not reported	Not reported	Not reported
MPR+p	9.3	6.55	Not reported	Not reported	Not reported
MPp+p	16.2	11.59	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
7.40
value
10.0
group Id
OG001
spread
6.55
value
9.3
group Id
OG002
spread
11.59
value
16.2

denoms

counts
group Id
OG000
value
117
group Id
OG001
value
104
group Id
OG002
value
77
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
OG000
title
MPR+R
description
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
OG001
title
MPR+p
description
Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
id
OG002
title
MPp+p

param Type

MEAN

population Description

Participants who had a partial response (PR) or complete response (CR)

reporting Status

POSTED

time Frame

Up to 66 weeks

title

Time to First Response

type

SECONDARY

unit Of Measure

weeks

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

Preserved source evidence · Not medical advice