Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00060203
Brief Summary:
RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.
Detailed Description:
OBJECTIVES:
* Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma.
* Determine the maximum tolerated dose of this drug in these patients.
* Determine the time to and duration of response, time to treatment failure, time to tumor progression, and survival in patients treated with this drug.
* Determine the safety and tolerability of this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.
* Correlate baseline whole blood levels and activity of glutathione with clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
* Phase I: Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
* Phase II: Additional patients are accrued and treated at the MTD of brostallicin as in phase I.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 23-52 patients will be accrued for this study.
Study:
NCT00060203
Study Brief:
Protocol Section:
NCT00060203