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NCT00259740 · OUTCOME

Complete Response, Partial Response or Minimal 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, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.

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

GroupSource count
Denosumab 120 mg Q4W - Plateau-Phase41
Denosumab 120 mg Q4W - Relapsed53

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Denosumab 120 mg Q4W - Plateau-Phase0Not reportedNot reportedNot reportedNot reported
Denosumab 120 mg Q4W - Relapsed0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      53
    units
    Participants
description
Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.
groups
  1. 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
  2. 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, Partial Response or Minimal 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