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NCT00742560 · OUTCOME

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1

What was measured

The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.

Analysis population: No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).

Groups in this outcome

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.

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 Dexamethasone0
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone0
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.
groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
    id
    OG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
    id
    OG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
    id
    OG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
population Description
No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).
reporting Status
POSTED
time Frame
Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1
title
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab
type
SECONDARY

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

Preserved source evidence · Not medical advice