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NCT01592370 · OUTCOME

Best Overall Response - Multiple Myeloma Group

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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

Measure
NUMBER
Unit
Percentage
Interval / dispersion
95% Confidence Interval
Time frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

What was measured

the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.

Analysis population: All Treated participants with available measurements in the Multiple Myeloma (MM) Group

Groups in this outcome

Nivolumab Monotherapy (Expansion)

3mg/kg of nivolumab

Nivolumab + Ipilimumab

3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W

Nivolumab + Lirilumab

3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)27
Nivolumab + Ipilimumab7
Nivolumab + Lirilumab10

Reported measurements

Complete Remission

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)27
Nivolumab + Ipilimumab7
Nivolumab + Lirilumab10
Values in Percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)3.7Not reported0.119.0Not reported
Nivolumab + Ipilimumab0Not reported0.041.0Not reported
Nivolumab + Lirilumab0Not reported0.030.8Not reported
Partial Remission

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)27
Nivolumab + Ipilimumab7
Nivolumab + Lirilumab10
Values in Percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)0Not reported0.012.8Not reported
Nivolumab + Ipilimumab0Not reported0.041.0Not reported
Nivolumab + Lirilumab0Not reported0.030.8Not reported
Very Good Partial Response

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)27
Nivolumab + Ipilimumab7
Nivolumab + Lirilumab0
Values in Percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)0Not reported0.012.8Not reported
Nivolumab + Ipilimumab0Not reported0.041.0Not reported
Stringent Compete Response

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)27
Nivolumab + Ipilimumab7
Nivolumab + Lirilumab0
Values in Percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)0Not reported0.012.8Not reported
Nivolumab + Ipilimumab0Not reported041.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        19.0
        value
        3.7
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        41.0
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        30.8
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    Complete Remission
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        12.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        41.0
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        30.8
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    Partial Remission
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        12.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        41.0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Very Good Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        12.8
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        41.0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Stringent Compete Response
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      10
    units
    Participants
description
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    3mg/kg of nivolumab
    id
    OG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    OG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    OG002
    title
    Nivolumab + Lirilumab
param Type
NUMBER
population Description
All Treated participants with available measurements in the Multiple Myeloma (MM) Group
reporting Status
POSTED
time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
title
Best Overall Response - Multiple Myeloma Group
type
SECONDARY
unit Of Measure
Percentage

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

Preserved source evidence · Not medical advice