NCT01985126 · OUTCOME

Progression Free Survival

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD · Source last updated 2018-06-25

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 14.4 Months

What was measured

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.

Analysis population: All treated analysis set included all participants who received at least 1 dose of daratumumab.

Groups in this outcome

Daratumumab 8 mg/kg

Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.

Daratumumab 16 mg/kg

Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.

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	18
Daratumumab 16 mg/kg	106

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Daratumumab 8 mg/kg	4.86	Not reported	1.84	NA	Upper limit of CI was not estimable due to the relatively short duration of follow-up.
Daratumumab 16 mg/kg	3.65	Not reported	2.76	4.63	Not reported

Complete source fields

classes

categories
measurements
comment
Upper limit of CI was not estimable due to the relatively short duration of follow-up.
group Id
OG000
lower Limit
1.84
upper Limit
NA
value
4.86
group Id
OG001
lower Limit
2.76
upper Limit
4.63
value
3.65

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
106
units
Participants

description

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.

dispersion Type

95% Confidence Interval

groups

description
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
id
OG000
title
Daratumumab 8 mg/kg
description
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
id
OG001
title
Daratumumab 16 mg/kg

param Type

MEDIAN

population Description

All treated analysis set included all participants who received at least 1 dose of daratumumab.

reporting Status

POSTED

time Frame

Up to 14.4 Months

title

Progression Free Survival

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice