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NCT01009840 · OUTCOME

Percent Difference Between Area Under Curve (AUC) and Target AUC

IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients · Source last updated 2026-05-13

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

Measure
MEDIAN
Unit
Percent difference
Interval / dispersion
Full Range
Time frame
Baseline (Day -12 to -9), Day -5

What was measured

A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM\*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.

Analysis population: Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.

Groups in this outcome

IV Busulfan

Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.

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

Analysis denominator · Participants

GroupSource count
IV Busulfan30

Reported measurements

Source class 1
Values in Percent difference · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
IV Busulfan-0.22Not reported-10.9718.55Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.97
        upper Limit
        18.55
        value
        -0.22
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day -12 to -9) to verify a target busulfan integrated AUC of 20,000 μM\*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.
dispersion Type
Full Range
groups
  1. description
    Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
    id
    OG000
    title
    IV Busulfan
param Type
MEDIAN
population Description
Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.
reporting Status
POSTED
time Frame
Baseline (Day -12 to -9), Day -5
title
Percent Difference Between Area Under Curve (AUC) and Target AUC
type
SECONDARY
unit Of Measure
Percent difference

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

Preserved source evidence · Not medical advice