Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies
filgrastim
+ sargramostim
+ cyclophosphamide
Amyloidosis+43
+ Blood Protein Disorders
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: September 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the safety and efficacy of myeloablative therapy with autologous hematopoietic stem cell transplantation in patients with multiple myeloma and other B-cell malignancies. Determine the efficacy and pretransplantation prognostic factors associated with myeloablative therapy in these patients. Determine engraftment kinetics of granulocytes and platelets, as well as blood product transfusion requirements following hematopoietic stem cell transplantation. OUTLINE: Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy. Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care. Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Peripheral blood stem cells and/or bone marrow is reinfused on day 0. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered beginning on day 1 posttransplantation and continuing until blood counts recover. Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation (TBI). Melphalan is administered IV on day -4. Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1. At least 4 hours must elapse between each treatment. Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0. If patient is ineligible for melphalan plus TBI, the alternative single high dose regimen of melphalan plus cyclophosphamide is administered. Melphalan, for these patients, is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2. Hematopoietic stem cells are reinfused on day 0. A second transplant may be considered, preferably between 3 and 6 months after the first transplant. The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above. The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide. For patients receiving melphalan alone, melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Hematopoietic stem cells are reinfused on day 0 for both alternative regimens. Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival. PROJECTED ACCRUAL: A minimum of 10 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma or other B-cell malignancy including non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis Non-Hodgkin's lymphoma with T-cell immunophenotypes included PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 (unless due to disease) Platelet count at least 100,000/mm^3 (unless due to disease) Hepatic: Not specified Renal: Not specified Cardiovascular: LVEF at least 40% Pulmonary: DLCO or FVC and FEV1 at least 50% of predicted unless due to restriction from volume loss secondary to disease Other: HIV negative No overt infection or unexplained fever requiring broad spectrum antibiotics Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy Chemotherapy: At least 2 weeks since other prior chemotherapy and recovered Endocrine therapy: At least 2 weeks since prior endocrine therapy Concurrent steroids allowed Radiotherapy: Not specified Surgery: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Medical College of Wisconsin
Milwaukee, United StatesOpen Medical College of Wisconsin in Google Maps