NCT00325416 · OUTCOME

Pharmacokinetic Profiles of High Dose Topotecan and Melphalan

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma. · Source last updated 2018-03-14

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Predetermined time points in protocol

What was measured

Evaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.

Groups in this outcome

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

Reported measurements

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

Complete source fields

denom Units Selected: Participants
description: Evaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.
reporting Status: NOT_POSTED
time Frame: Predetermined time points in protocol
title: Pharmacokinetic Profiles of High Dose Topotecan and Melphalan
type: OTHER_PRE_SPECIFIED

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Preserved source evidence · Not medical advice