Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Drug: brostallicin

• Registration Number: NCT00060203
• Lead Sponsor: Case Comprehensive Cancer Center

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 Timeline

• Study Start: 2002-12
• Primary Completion: 2003-03
• Study First Submitted: 2003-05-06
• Study First Submitted QC: 2003-05-06
• Study First Posted: 2003-05-07
• Study Completion: 2004-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brostallicin	brostallicin	-

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response Rate	1 year	• Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma

Secondary Outcome Measures

Name	Time	Method
Time to response	1 year
Duration of Response	1 year
Time to treatment failure	1 year
Time to tumor progression	1 year
Maximum Tolerated Dose of brostallicin	1 year
Overall Survival	1 year

Trial Locations

Locations (1)

Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States