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NCT01348919 · OUTCOME

Area Under the Plasma Concentration-Time Curve From Time 0 to t (AUC0-t) of CEP-18770

Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2023-06-28

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

Measure
MEAN
Unit
ng*hours/mL
Interval / dispersion
Standard Deviation
Time frame
Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1

Analysis population: PK analysis set included all participants for whom at least 1 PK parameter can be calculated. Here, number analyzed = participants evaluable at specified timepoint.

Groups in this outcome

CEP-18770 Dose A

Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.

CEP-18770 Dose B

Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.

CEP-18770 Dose C

Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
CEP-18770 Dose A3
CEP-18770 Dose B5
CEP-18770 Dose C3

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
CEP-18770 Dose A3
CEP-18770 Dose B5
CEP-18770 Dose C3
Values in ng*hours/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CEP-18770 Dose A673618Not reportedNot reportedNot reported
CEP-18770 Dose B1371656Not reportedNot reportedNot reported
CEP-18770 Dose C1527357Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
CEP-18770 Dose A3
CEP-18770 Dose B5
CEP-18770 Dose C1
Values in ng*hours/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CEP-18770 Dose A1595677Not reportedNot reportedNot reported
CEP-18770 Dose B20711240Not reportedNot reportedNot reported
CEP-18770 Dose C2266Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        618
        value
        673
      2. group Id
        OG001
        spread
        656
        value
        1371
      3. group Id
        OG002
        spread
        357
        value
        1527
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        677
        value
        1595
      2. group Id
        OG001
        spread
        1240
        value
        2071
      3. group Id
        OG002
        value
        2266
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      3
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG000
    title
    CEP-18770 Dose A
  2. description
    Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG001
    title
    CEP-18770 Dose B
  3. description
    Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG002
    title
    CEP-18770 Dose C
param Type
MEAN
population Description
PK analysis set included all participants for whom at least 1 PK parameter can be calculated. Here, number analyzed = participants evaluable at specified timepoint.
reporting Status
POSTED
time Frame
Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1
title
Area Under the Plasma Concentration-Time Curve From Time 0 to t (AUC0-t) of CEP-18770
type
SECONDARY
unit Of Measure
ng*hours/mL

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Preserved source evidence · Not medical advice