Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma (MM) Patients with a prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma are eligible if they progressed and met the criteria for diagnosis of MM No non-secretory MM No symptomatic MGUS, smoldering MM, or indolent MM No solitary bone or extramedullary plasmacytoma No immunoglobulin M myeloma Prior induction therapy for myeloma required Responding, stable, or progressive disease after induction therapy, or relapsed disease Candidate for autologous hematopoietic stem cell transplantation Prior stem cell mobilization with chemotherapy and growth factors according to institutional procedures Availability of at least 2,000,000 CD34+ cells/kg PATIENT CHARACTERISTICS: Age 18 to 70 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin no greater than 2 mg/dL SGPT no greater than 2 times upper limit of normal No clinical evidence of amyloidosis of the liver Renal Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 45 mL/min Renal ultrasound normal No clinical evidence of amyloidosis of the kidney No urinary obstruction in the renal pelvis, ureter, or bladder outlet by ultrasound Cardiovascular Ejection fraction at least 50% with no evidence of amyloidosis by echocardiogram No clinical evidence of amyloidosis of the heart No uncontrolled arrhythmia No symptomatic cardiac disease Pulmonary FEV1, FVC, and DLCO at least 60% No symptomatic pulmonary disease No clinical evidence of amyloidosis of the lungs Other No known allergy to vitamin C or bisphosphonates No known hypersensitivity to technetium Tc 99m phosphorus radiopharmaceuticals (e.g., technetium Tc 99m-methylene diphosphonate) No concurrent illness that would severely limit life expectancy No symptoms, physical findings, or radiographic evidence of cord compression No clinical evidence of amyloidosis of the autonomic nervous system or gastrointestinal tract No prior noncompliance in other studies No other malignancy within the past 5 years except treated indolent skin cancers or carcinoma in situ of the cervix HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior stem cell or bone marrow transplantation No concurrent maintenance therapy comprising interferon or thalidomide Chemotherapy See Disease Characteristics Endocrine therapy See Disease Characteristics No concurrent maintenance therapy comprising dexamethasone Radiotherapy No prior cumulative external-beam radiotherapy (EBRT) to more than 20% of bone marrow No prior cumulative EBRT dose of 30 Gy or more to the spinal cord No prior radiotherapy to the bladder Surgery See Disease Characteristics Other At least 4 weeks since prior investigational agents for MM At least 4 weeks since other prior experimental therapies for any other condition No bisphosphonates for at least 4 weeks before study, during study, and for at least 30 days posttransplantation
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of California Davis Cancer Center
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
- University of Texas - MD Anderson Cancer Center
- Fred Hutchinson Cancer Research Center