Phase
Condition
Lymphoproliferative Disorders
Multiple Myeloma
Cancer/tumors
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama 35294-0006
United StatesSite Not Available
University of California Davis Cancer Center
Sacramento, California 95817
United StatesSite Not Available
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee 37212
United StatesSite Not Available
University of Texas - MD Anderson Cancer Center
Houston, Texas 77030-4009
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-1024
United StatesSite Not Available

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