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NCT01478048 · OUTCOME

1 Year Progression-Free Survival Rate - Randomized Participants

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2018-05-21

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

Measure
NUMBER
Unit
percentage probability
Interval / dispersion
95% Confidence Interval
Time frame
Year 1 after last participant was randomized

What was measured

PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase \> 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.

Analysis population: All randomized participants were analyzed.

Groups in this outcome

Elotuzumab + Bortezomib + Dexamethasone

Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation

Bortezomib + Dexamethasone

Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug

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 + Bortezomib + Dexamethasone77
Bortezomib + Dexamethasone75

Reported measurements

Source class 1
Values in percentage probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Elotuzumab + Bortezomib + Dexamethasone0.39Not reported0.280.50Not reported
Bortezomib + Dexamethasone0.33Not reported0.220.44Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.28
        upper Limit
        0.50
        value
        0.39
      2. group Id
        OG001
        lower Limit
        0.22
        upper Limit
        0.44
        value
        0.33
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    2. group Id
      OG001
      value
      75
    units
    Participants
description
PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase \> 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
dispersion Type
95% Confidence Interval
groups
  1. description
    Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation
    id
    OG000
    title
    Elotuzumab + Bortezomib + Dexamethasone
  2. description
    Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
    id
    OG001
    title
    Bortezomib + Dexamethasone
param Type
NUMBER
population Description
All randomized participants were analyzed.
reporting Status
POSTED
time Frame
Year 1 after last participant was randomized
title
1 Year Progression-Free Survival Rate - Randomized Participants
type
PRIMARY
unit Of Measure
percentage probability

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

Preserved source evidence · Not medical advice