Antithymocyte Globulin and Sirolimus in Treating Patients With Relapsed Multiple Myeloma

Phase 1

Completed

• Conditions: Drug/Agent Toxicity by Tissue/Organ; Multiple Myeloma and Plasma Cell Neoplasm

• Registration Number: NCT00317798
• Lead Sponsor: University of Rochester

Brief Summary

RATIONALE: Biological therapies, such as antithymocyte globulin may stimulate the immune system in different ways and stop cancer cells from growing. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also prevent or reduce the side effects of antithymocyte globulin. Giving antithymocyte globulin together with sirolimus may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of antithymocyte globulin when given together with sirolimus in treating patients with relapsed multiple myeloma.

Detailed Description

OBJECTIVES:

Primary

* Determine the safety and tolerability, in terms of clinical and laboratory toxicity, of anti-thymocyte globulin (ATG) combined with sirolimus in patients with relapsed multiple myeloma.

* Determine the dose-limiting toxicity of this regimen in these patients.

* Determine the maximum tolerated dose of ATG when administered with sirolimus in these patients.

Secondary

* Determine the clinical activity of this regimen, in terms of measurability of improvement in clinical benefits, in these patients.

* Assess patients for sensitivity of CD 138\^-positive myeloma cells to ATG prior to treatment.

* Determine the pharmacokinetics, in terms of ATG levels in blood and bone marrow, in these patients.

* Assess the binding capability of ATG to bone marrow resident myeloma cells.

* Determine if an ATG-resistant clone emerges after treatment.

OUTLINE: This is an open-label, pilot, dose-escalation study of anti-thymocyte globulin (ATG).

Patients receive ATG IV over 6-12 hours for 4, 6, or 8 days and oral sirolimus once daily on days 1-30 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ATG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Bone marrow aspirates and blood samples are collected at baseline and periodically during study treatment for drug sensitivity and pharmacokinetic studies.

After completion of study treatment, patients are followed every 3 weeks for up to 2 months and then monthly thereafter.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-25
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity and maximum tolerated dose	Duration of the study

Secondary Outcome Measures

Name	Time	Method
Relapse rates as measured by standard response criteria	Duration of the study
Laboratory correlative studies	During treatment

Trial Locations

Locations (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States