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NCT00742560 · OUTCOME

Progression-free Survival (PFS)

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma · Source last updated 2018-01-10

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
From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months

What was measured

PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided.

Analysis population: Safety population: All randomized participants who received at least 1 dose of study drug

Groups in this outcome

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Total (Phase 1)

Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Total (Phase 2)

Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

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

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)3
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)22
Total (Phase 1)28
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)36
Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat37
Total (Phase 2)73

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)6.08Not reported6.056.08Not reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)22.23Not reported11.532.9Not reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)NANot reportedNANANA=Median was not reached (max value was 58.91)
Total (Phase 1)32.92Not reported7.43NANA=Not calculable due to insufficient survival events
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)32.49Not reported14.9NANA=Not calculable due to insufficient survival events
Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat25.00Not reported14.035.7Not reported
Total (Phase 2)28.62Not reported16.643.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.05
        upper Limit
        6.08
        value
        6.08
      2. group Id
        OG001
        lower Limit
        11.5
        upper Limit
        32.9
        value
        22.23
      3. comment
        NA=Median was not reached (max value was 58.91)
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        NA=Not calculable due to insufficient survival events
        group Id
        OG003
        lower Limit
        7.43
        upper Limit
        NA
        value
        32.92
      5. comment
        NA=Not calculable due to insufficient survival events
        group Id
        OG004
        lower Limit
        14.9
        upper Limit
        NA
        value
        32.49
      6. group Id
        OG005
        lower Limit
        14.0
        upper Limit
        35.7
        value
        25.00
      7. group Id
        OG006
        lower Limit
        16.6
        upper Limit
        43.1
        value
        28.62
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      22
    4. group Id
      OG003
      value
      28
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      37
    7. group Id
      OG006
      value
      73
    units
    Participants
description
PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided.
dispersion Type
95% Confidence Interval
groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  4. description
    Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG003
    title
    Total (Phase 1)
  5. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG004
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  6. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG005
    title
    Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat
  7. description
    Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    OG006
    title
    Total (Phase 2)
param Type
MEDIAN
population Description
Safety population: All randomized participants who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice