Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01985126 · OUTCOME

Percentage of Participants With Clinical Benefit

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 14.4 Months

What was measured

Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: \>=25% but \<= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas.

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

GroupSource count
Daratumumab 8 mg/kg18
Daratumumab 16 mg/kg106

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Daratumumab 8 mg/kg22.2Not reported6.447.6Not reported
Daratumumab 16 mg/kg34.0Not reported25.043.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.4
        upper Limit
        47.6
        value
        22.2
      2. group Id
        OG001
        lower Limit
        25.0
        upper Limit
        43.8
        value
        34.0
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      106
    units
    Participants
description
Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: \>=25% but \<= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
NUMBER
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
Percentage of Participants With Clinical Benefit
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice