Phase
Condition
Leukemia
Lymphoproliferative Disorders
Multiple Myeloma
Treatment
N/AClinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma
M-protein by serum protein electrophoresis or urine protein electrophoresis
Quantitative determination of immunoglobulin
Bone marrow biopsy and aspirate with a plasma cell count greater than 10%
Refractory or chemoresistant disease defined as failure to respond (less than 50% reduction in M protein level) or progression within 2 months after receiving at least 2 chemotherapy regimens including:
Alkylating based regimen (melphalan) in combination with steroids (prednisone) or other chemotherapy regimens (e.g., vincristine, bleomycin, melphalan, cyclophosphamide, and prednisone or vincristine, carmustine, doxorubicin, and prednisone)
Vincristine, doxorubicin, and dexamethasone (VAD) regimen
Pulse therapy with high dose steroids alone
High dose alkylating agent and autologous stem cell transplantation
Allogeneic bone marrow transplantation
Plateau phase defined as M protein in the serum or urine for more than 6 weeks despite response to prior therapy
Must have received at least 2 of the chemotherapy regimens listed above or equivalent regimens
Recurrent disease defined as progression more than 2 months after initial therapy and failure to respond (less than 50% reduction or progression in M protein levels) to 1 chemotherapy regimen listed above or other salvage regimens (e.g., high-dose cyclophosphamide or topotecan)
Must have received VAD or other equivalent chemotherapy regimen
Should be considered for autologous or allogenic transplantation
Prior local radiotherapy allowed
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
WBC at least 2,000/mm^3*
Platelet count at least 50,000/mm^3* NOTE: *Unless attributable to bone marrow infiltration by multiple myeloma
Hepatic:
Bilirubin less than 3 mg/dL
Transaminases less than 2.5 times upper limit of normal (ULN)
Renal:
Creatinine less than 1.5 times ULN OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
No cardiac arrhythmias including recurrent supraventricular arrhythmia, any type of sustained ventricular arrhythmia, or conduction block (atrioventricular block grade II or III, left bundle branch block)
Ejection fraction at least 30%
No uncontrolled ischemic heart disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 4 months after study
HIV negative
No grade 3 or higher neurological disorder, including seizure disorders
No underlying medical condition that would preclude study
No other active malignancy except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
See Disease Characteristics
At least 2 weeks since prior chemotherapy
Endocrine therapy:
See Disease Characteristics
Concurrent steroid treatment allowed except for primary treatment of myeloma
Radiotherapy:
See Disease Characteristics
Concurrent local radiotherapy for pain or symptom control allowed provided the pain or symptom is not related to disease progression
Surgery:
- Not specified
Other:
No other concurrent ascorbic acid supplements
No other concurrent investigational drug or therapy
Concurrent bisphosphonates allowed
Study Design
Study Description
Connect with a study center
Baptist-South Miami Regional Cancer Program
Miami, Florida 33176-2197
United StatesSite Not Available
Cedars Medical Center
Miami, Florida 33136
United StatesSite Not Available
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesSite Not Available
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
Miami Beach, Florida 33140
United StatesSite Not Available

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