Phase
Condition
Multiple Myeloma
Bone Neoplasm
Cancer/tumors
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation
Patients must meet Salmon and Durie criteria for initial diagnosis of MM
Transplant will be offered to patients with stage II or III MM
Measurable disease, defined as serum monoclonal protein >= 0.2 g/dl or Bence Jonesprotein >= 200 mg/24 h
Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy is not severely limited by concomitant illness
Left ventricular ejection fraction >= 50%
No uncontrolled arrhythmias or symptomatic cardiac disease
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), anddiffusion capacity of carbon monoxide (DLCO) >= 50%
No symptomatic pulmonary disease
Human immunodeficiency virus (HIV) negative
Bilirubin < 2 mg/dl
Serum glutamic pyruvate transaminase (SGPT) < 2.5 x normal
Creatinine clearance >= 60 cc/min, estimated or measured
Signed informed consent
Exclusion
Exclusion Criteria:
Pregnant or lactating females
Uncontrolled infection
Planned tandem autologous/reduced intensity allograft
Insufficient PBSC for an autologous transplant (< 3.0 x 10^6 CD34+ cells/kg total)
Prior autologous transplant
Non-secretory myeloma and patients who are in a complete response or near completeresponse after conventional therapy
Patients unwilling to practice adequate forms of contraception if clinically indicated
Male patients on study need to be consulted to use latex condoms, even if they havehad a vasectomy, every time they have sex with a woman who is able to have children
Patients with history of seizures
Patients receiving antihypertensive therapy that cannot be stopped for 24 hourspreceding amifostine treatment
Study Design
Study Description
Connect with a study center
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Memorial Cancer Institute
Pembroke Pines, Florida 33028
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington 98109
United StatesSite Not Available
VA Puget Sound Health Care System
Seattle, Washington 98101
United StatesSite Not Available
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