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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378768
• Other study ID #: 2029.00
• Secondary ID: FHCRC-2029.00GEN
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2006
• Last updated: November 28, 2011
• Start date: November 2005
• Est. completion date: June 2007

Study information

• Verified date: November 2011
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• anti-thymocyte globulin

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks			No
Secondary	Toxicity as assessed by NCI CTC v2.0			Yes
Secondary	Formation of antirabbit antibodies			No