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NCT00742560 · OUTCOME

Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months

What was measured

ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC\] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).

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.

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

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)100Not reported29.2100.0Not reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)100Not reported29.2100.0Not reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)77.3Not reported54.692.2Not reported
Total (Phase 1)82.1Not reported63.193.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100
      2. group Id
        OG001
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100
      3. group Id
        OG002
        lower Limit
        54.6
        upper Limit
        92.2
        value
        77.3
      4. group Id
        OG003
        lower Limit
        63.1
        upper Limit
        93.9
        value
        82.1
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
    units
    Participants
description
ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC\] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
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)
param Type
NUMBER
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 until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months
title
Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice