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Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma

NCT ID: NCT00378768

Last Updated: 2011-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-06-30

Brief Summary

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RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating patients undergoing stem cell transplant for multiple myeloma.

Detailed Description

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OBJECTIVES:

Primary

* Determine the response rate at 4 weeks in patients with multiple myeloma treated with anti-thymocyte globulin at least 4 to 6 weeks prior to undergoing conditioning therapy for allogeneic or autologous stem cell transplantation.

Secondary

* Determine the toxicity of this drug, in terms of formation of antirabbit antibodies, in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive anti-thymocyte globulin IV over 6 hours on day 1 and over 4 hours on days 3 and 5. Treatment begins 4 to 6 weeks prior to undergoing conditioning therapy for autologous or allogeneic stem cell transplantation.

After completion of study treatment, patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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anti-thymocyte globulin

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed multiple myeloma
* Candidate for autologous or allogeneic stem cell transplantation within 1 to 3 months after study treatment
* Measurable disease, defined as serum monoclonal protein ≥ 1 g/dL OR urinary light chain excretion = 500 mg/24 hours
* No malignant CNS disease

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 6 months
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count \> 50,000/mm³
* Creatinine ≤ 2 mg/dL
* Hepatic function ≤ 2 times upper limit of normal
* DLCO ≥ 50%
* No active infection
* No hypersensitivity to rabbit proteins
* No symptomatic hyperviscosity syndrome
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

* More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
* No prior anti-thymocyte globulin
* No concurrent radiotherapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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William I. Bensinger, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FHCRC-2029.00

Identifier Type: -

Identifier Source: secondary_id

GENZ-FHCRC-2029.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000500474

Identifier Type: REGISTRY

Identifier Source: secondary_id

2029.00

Identifier Type: -

Identifier Source: org_study_id