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NCT01782963 · OUTCOME

Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection

Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) · Source last updated 2018-10-31

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose

What was measured

The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.

Analysis population: A total of only 10 participants per arm were evaluated for drug plasma concentrations following Bortezomib administration.The number of participants vary by time-point due to missing measurements for the concentrations.

Groups in this outcome

Intravenous

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone

Subcutaneous

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide

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

Analysis denominator · Participants

GroupSource count
Intravenous10
Subcutaneous10

Reported measurements

Day 1, 5 minutes (min) post dose

Analysis denominator · Participants

GroupSource count
Intravenous10
Subcutaneous10
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous98.8439.27Not reportedNot reportedNot reported
Subcutaneous1315.79Not reportedNot reportedNot reported
Day 1, 30 min post dose

Analysis denominator · Participants

GroupSource count
Intravenous10
Subcutaneous10
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous8.735.59Not reportedNot reportedNot reported
Subcutaneous20.510.91Not reportedNot reportedNot reported
Day 1, 5 hours post dose

Analysis denominator · Participants

GroupSource count
Intravenous10
Subcutaneous9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous1.821.31Not reportedNot reportedNot reported
Subcutaneous1.960.56Not reportedNot reportedNot reported
Day 8 pre-dose

Analysis denominator · Participants

GroupSource count
Intravenous10
Subcutaneous10
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous0.440.15Not reportedNot reportedNot reported
Subcutaneous0.330.09Not reportedNot reportedNot reported
Day 15 pre-dose

Analysis denominator · Participants

GroupSource count
Intravenous8
Subcutaneous10
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous0.660.22Not reportedNot reportedNot reported
Subcutaneous0.490.12Not reportedNot reportedNot reported
Day 22 pre-dose

Analysis denominator · Participants

GroupSource count
Intravenous7
Subcutaneous9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous0.830.34Not reportedNot reportedNot reported
Subcutaneous0.660.18Not reportedNot reportedNot reported
Day 22, 5 min post-dose

Analysis denominator · Participants

GroupSource count
Intravenous7
Subcutaneous9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous114.376.6Not reportedNot reportedNot reported
Subcutaneous10.2913.24Not reportedNot reportedNot reported
Day 22, 30 min post-dose

Analysis denominator · Participants

GroupSource count
Intravenous7
Subcutaneous9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous14.94.3Not reportedNot reportedNot reported
Subcutaneous21.6910.1Not reportedNot reportedNot reported
Day 22, 5 hours post-dose

Analysis denominator · Participants

GroupSource count
Intravenous7
Subcutaneous9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous2.851.05Not reportedNot reportedNot reported
Subcutaneous4.162.07Not reportedNot reportedNot reported
Cycle 2 Day 1, pre-dose

Analysis denominator · Participants

GroupSource count
Intravenous9
Subcutaneous9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intravenous0.530.15Not reportedNot reportedNot reported
Subcutaneous0.490.14Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.27
        value
        98.84
      2. group Id
        OG001
        spread
        15.79
        value
        13
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Day 1, 5 minutes (min) post dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.59
        value
        8.73
      2. group Id
        OG001
        spread
        10.91
        value
        20.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Day 1, 30 min post dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.31
        value
        1.82
      2. group Id
        OG001
        spread
        0.56
        value
        1.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Day 1, 5 hours post dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.44
      2. group Id
        OG001
        spread
        0.09
        value
        0.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Day 8 pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.22
        value
        0.66
      2. group Id
        OG001
        spread
        0.12
        value
        0.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Day 15 pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.34
        value
        0.83
      2. group Id
        OG001
        spread
        0.18
        value
        0.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Day 22 pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.6
        value
        114.3
      2. group Id
        OG001
        spread
        13.24
        value
        10.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Day 22, 5 min post-dose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.3
        value
        14.9
      2. group Id
        OG001
        spread
        10.1
        value
        21.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Day 22, 30 min post-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.05
        value
        2.85
      2. group Id
        OG001
        spread
        2.07
        value
        4.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Day 22, 5 hours post-dose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.53
      2. group Id
        OG001
        spread
        0.14
        value
        0.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Cycle 2 Day 1, pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    units
    Participants
description
The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.
dispersion Type
Standard Deviation
groups
  1. description
    Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone
    id
    OG000
    title
    Intravenous
  2. description
    Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide
    id
    OG001
    title
    Subcutaneous
param Type
MEAN
population Description
A total of only 10 participants per arm were evaluated for drug plasma concentrations following Bortezomib administration.The number of participants vary by time-point due to missing measurements for the concentrations.
reporting Status
POSTED
time Frame
Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose
title
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice