NCT00574288 · OUTCOME

Part 2: Time to Response

Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma · Source last updated 2018-04-27

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

Measure: MEAN
Unit: months
Interval / dispersion: Standard Deviation
Time frame: Up to Week 27

What was measured

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. The Kaplan-Meier method was used to estimate time to response.

Analysis population: All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. Here 'n' (Number of Participants Analyzed) signifies number of participants analyzed at specific time point.

Groups in this outcome

Daratumumab 8 mg/kg

Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.

Daratumumab 16 mg/kg

Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.

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
Daratumumab 8 mg/kg	30
Daratumumab 16 mg/kg	42

Reported measurements

Time to first response

Analysis denominator · Participants

Group	Source count
Daratumumab 8 mg/kg	3
Daratumumab 16 mg/kg	15

Values in months · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab 8 mg/kg	1.36	0.774	Not reported	Not reported	Not reported
Daratumumab 16 mg/kg	1.33	0.955	Not reported	Not reported	Not reported

Time to best response

Analysis denominator · Participants

Group	Source count
Daratumumab 8 mg/kg	3
Daratumumab 16 mg/kg	15

Values in months · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab 8 mg/kg	1.36	0.774	Not reported	Not reported	Not reported
Daratumumab 16 mg/kg	2.46	2.800	Not reported	Not reported	Not reported

Time to VGPR or better response

Analysis denominator · Participants

Group	Source count
Daratumumab 8 mg/kg	0
Daratumumab 16 mg/kg	4

Values in months · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab 16 mg/kg	0.49	0.000	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.774
value
1.36
group Id
OG001
spread
0.955
value
1.33
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
15
units
Participants
title
Time to first response
categories
measurements
group Id
OG000
spread
0.774
value
1.36
group Id
OG001
spread
2.800
value
2.46
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
15
units
Participants
title
Time to best response
categories
measurements
group Id
OG001
spread
0.000
value
0.49
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
units
Participants
title
Time to VGPR or better response

denoms

counts
group Id
OG000
value
30
group Id
OG001
value
42
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.
id
OG000
title
Daratumumab 8 mg/kg
description
Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
id
OG001
title
Daratumumab 16 mg/kg

param Type

MEAN

population Description

All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. Here 'n' (Number of Participants Analyzed) signifies number of participants analyzed at specific time point.

reporting Status

POSTED

time Frame

Up to Week 27

title

Part 2: Time to Response

type

SECONDARY

unit Of Measure

months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice