Status:
TERMINATED
Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, w...
Detailed Description
OBJECTIVES: Primary \* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma. Secondary * To assess ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- \- Relapsed disease
- Must not be a candidate for stem cell transplantation, has refused transplantation, or has had stem cells collected previously
- Measurable disease, defined by ≥ 1 of the following:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- More than 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Absolute neutrophil count ≥ 1,000/μL
- Platelet count ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL
- CD4 \> 100/μL
- Creatinine ≤ 3 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active malignancy with the exception of nonmelanoma skin cancer or in situ cervical or breast cancer
- No uncontrolled infection
- No other co-morbidity that would interfere with patient's ability to participate in trial
- PRIOR CONCURRENT THERAPY:
- No limit to prior therapy
- At least 4 weeks since prior melphalan or other myelosuppressive agents
- At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
- No concurrent high-dose corticosteroids
- Concurrent chronic steroids (maximum dose 20 mg/day prednisone equivalent) allowed if they are being given for disorders other than amyloid (e.g., adrenal insufficiency or rheumatoid arthritis)
- Concurrent continuation of low level/stable steroid doses for replacement or inhalation therapy allowed
- Concurrent bisphosphonates allowed
- No concurrent immunosuppressive medications such as cyclosporine
- No other concurrent investigational treatment
- No concurrent cytotoxic chemotherapy or external-beam radiotherapy\>
- No other concurrent systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
- No concurrent prophylactic hematopoietic growth factors (unless for treatment of an established cytopenia)
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00635024
Start Date
May 1 2008
End Date
November 1 2010
Last Update
February 10 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905