Interferon Maintenance in Advanced Multiple Myeloma After Using High-Dose Melphalan as Myeloablative Chemotherapy: A Pilot Study
recombinant interferon alfa
+ sargramostim
+ cyclophosphamide
Blood Protein Disorders+12
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: July 1, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the effectiveness of interferon alfa-2b maintenance following high dose melphalan chemotherapy for patients with advanced multiple myeloma. II. Determine the response rate to high dose dexamethasone therapy using sequential noncrossresistant chemotherapies for patients with advanced multiple myeloma. OUTLINE: Patients receive high dose dexamethasone on days 1-4, 9-12, and 17-20, followed by 4 weeks rest. Cyclophosphamide (CTX) is administered intravenously in combination with mesna following dexamethasone therapy. Sargramostim (GM-CSF) is initiated subcutaneously 1 day later and is continued for 10 days to support stem cell collections, which begin 10-14 days after CTX induction. Following 4 weeks of rest, melphalan (L-PAM) is administered over 1 hour. Stem cell rescue is begun 48 hours after L-PAM therapy. Three to 4 months after the first L-PAM course, a second L-PAM and stem cell rescue is undertaken. Interferon alfa-2b (IFN-A) maintenance is administered 3 times per week following bone marrow recovery from the first or second L-PAM courses. Patients achieving complete remission following the first course of L-PAM may proceed directly to IFN-A maintenance. Patients achieving greater than grade 3 nonhematologic toxicity or not achieving an absolute neutrophil count of greater than 1,000/mm3 by day 21 posttransplant are not eligible for dose escalation. PROJECTED ACCRUAL: A minimum of 30 patients will be enrolled.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.From 19 to 64 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: See General Eligibility Criteria PATIENT CHARACTERISTICS: Age: 19 to 64 Performance Status: Zubrod 0-3 Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL SGOT and SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: No history of severe chronic obstructive lung disease No history of recurrent pulmonary emboli Other: Not pregnant or nursing Effective contraception should be practiced by fertile patients No history of diabetes mellitus complicated by ketoacidosis No history of depression or psychosis No history of autoimmune disorders No concurrent thyroid disorders unable to be maintained on replacement therapy No prior hypersensitivity to interferon alfa-2b PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 12 months of prior alkylator therapy Endocrine Therapy: Not specified 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 4 locations
Methodist Healthcare - Hospital of Memphis
Memphis, United StatesBaptist Memorial Hospital
Memphis, United StatesUniversity of Tennessee, Memphis
Memphis, United States