Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00378768

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: anti-thymocyte globulin	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
Formation of antirabbit antibodies [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	November 2005

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378768

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William I. Bensinger, MD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000500474, FHCRC-2029.00, GENZ-FHCRC-2029.00
Study First Received:	September 19, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00378768 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Immunosuppressive Agents
Multiple Myeloma
Antilymphocyte Serum
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Immunosuppressive Agents
Pharmacologic Actions
Multiple Myeloma
Antilymphocyte Serum
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009