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NCT01348919 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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
nanograms (ng)/ milliliter (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: The pharmacokinetic (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 nanograms (ng)/ milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CEP-18770 Dose A579.49118.48Not reportedNot reportedNot reported
CEP-18770 Dose B663.00164.84Not reportedNot reportedNot reported
CEP-18770 Dose C876.97211.99Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
CEP-18770 Dose A3
CEP-18770 Dose B5
CEP-18770 Dose C1
Values in nanograms (ng)/ milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CEP-18770 Dose A639.59242.96Not reportedNot reportedNot reported
CEP-18770 Dose B628.07291.34Not reportedNot reportedNot reported
CEP-18770 Dose C977.09Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        118.48
        value
        579.49
      2. group Id
        OG001
        spread
        164.84
        value
        663.00
      3. group Id
        OG002
        spread
        211.99
        value
        876.97
    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
        242.96
        value
        639.59
      2. group Id
        OG001
        spread
        291.34
        value
        628.07
      3. group Id
        OG002
        value
        977.09
    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
The pharmacokinetic (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
Maximum Observed Plasma Concentration (Cmax) of CEP-18770
type
SECONDARY
unit Of Measure
nanograms (ng)/ milliliter (mL)

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Preserved source evidence · Not medical advice