NCT00240162 · OUTCOME

Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug

PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma · Source last updated 2014-09-17

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Day 90

Analysis population: Participants were evaluable for response if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.

Groups in this outcome

PTK787/ZK 222584

Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.

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
PTK787/ZK 222584	10

Reported measurements

Complete response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PTK787/ZK 222584	0	Not reported	Not reported	Not reported	Not reported

Partial response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PTK787/ZK 222584	1	Not reported	Not reported	Not reported	Not reported

No response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PTK787/ZK 222584	9	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
title
Complete response
categories
measurements
group Id
OG000
value
1
title
Partial response
categories
measurements
group Id
OG000
value
9
title
No response

denoms

counts
group Id
OG000
value
10
units
Participants

groups

description
Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
id
OG000
title
PTK787/ZK 222584

param Type

NUMBER

population Description

Participants were evaluable for response if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.

reporting Status

POSTED

time Frame

Day 90

title

Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice