A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma
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 the toxicity and tolerability of this combination in these patients.
- To assess time to disease progression in patients treated with these drugs.
- To assess survival of patients treated with these drugs. OUTLINE: Patients receive
anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats
every 28 days for 6 courses. Patients then receive melphalan alone as above for another
6 courses. Treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 2 years.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
Outcome Description:
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Shaji K. Kumar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000589032
NCT ID:
NCT00635024
Start Date:
May 2008
Completion Date:
November 2010
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
