A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
N/A
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
Safety Issue:
No
Principal Investigator
William I. Bensinger, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
2029.00
NCT ID:
NCT00378768
Start Date:
November 2005
Completion Date:
June 2007
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
