NCT00259740 · OUTCOME

Complete Response Based on M-Protein Assessments Only

Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab · Source last updated 2017-03-15

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: Up to 18 months

What was measured

Complete response based on M-protein assessments, as defined for the primary outcome measure.

Analysis population: All participants who completed the first cycle of treatment with denosumab

Groups in this outcome

Denosumab 120 mg Q4W - Plateau-Phase

Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma

Denosumab 120 mg Q4W - Relapsed

Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma

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
Denosumab 120 mg Q4W - Plateau-Phase	41
Denosumab 120 mg Q4W - Relapsed	53

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Denosumab 120 mg Q4W - Plateau-Phase	0	Not reported	Not reported	Not reported	Not reported
Denosumab 120 mg Q4W - Relapsed	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0

denoms

counts
group Id
OG000
value
41
group Id
OG001
value
53
units
Participants

description

Complete response based on M-protein assessments, as defined for the primary outcome measure.

groups

description
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
id
OG000
title
Denosumab 120 mg Q4W - Plateau-Phase
description
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
id
OG001
title
Denosumab 120 mg Q4W - Relapsed

param Type

NUMBER

population Description

All participants who completed the first cycle of treatment with denosumab

reporting Status

POSTED

time Frame

Up to 18 months

title

Complete Response Based on M-Protein Assessments Only

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice