NCT01478048 · OUTCOME

Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All 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: Events (progression or death)
Interval / dispersion: Not reported
Time frame: Randomization until 111 events, up to May 2014, approximately 2 years

What was measured

PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.

Analysis population: Intent to treat (ITT), 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

Group	Source count
Elotuzumab + Bortezomib + Dexamethasone	77
Bortezomib + Dexamethasone	75

Reported measurements

Source class 1

Values in Events (progression or death) · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Elotuzumab + Bortezomib + Dexamethasone	52	Not reported	Not reported	Not reported	Not reported
Bortezomib + Dexamethasone	59	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
52
group Id
OG001
value
59

denoms

counts
group Id
OG000
value
77
group Id
OG001
value
75
units
Participants

description

groups

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
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

Intent to treat (ITT), all randomized participants were analyzed.

reporting Status

POSTED

time Frame

Randomization until 111 events, up to May 2014, approximately 2 years

title

Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

type

PRIMARY

unit Of Measure

Events (progression or death)

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Preserved source evidence · Not medical advice