Autologous Transplantation With Gemcitabine and High Dose BCNU Plus Melphalan Followed by Consolidation With DCEP Plus Gemcitabine and Taxol/Cisplatin in Patients With Multiple Myeloma and >12 Months of Standard Therapy
carmustine
+ cisplatin
+ cyclophosphamide
Blood Protein Disorders+12
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients receiving peripheral blood stem cells supported by gemcitabine and high dose carmustine and melphalan followed by consolidation therapy with gemcitabine plus cyclophosphamide/dexamethasone/etoposide/cisplatin (DCEP) and dexamethasone/paclitaxel/cisplatin. II. Evaluate the incidence of early death in comparison with historical data in this patient population. III. Evaluate the feasibility of chemotherapy with gemcitabine plus DCEP and dexamethasone/paclitaxel/cisplatin following autotransplantation in these patients. OUTLINE: Patients receive gemcitabine IV over 100 minutes on day -5 and again 6 hours after administration of carmustine IV over 2 hours on day -2, followed by melphalan IV over 20 minutes on day -1. Patients receive intravenous CD34 peripheral blood stem cells on day 0. At 3 months and 9 months, patients with adequate hematologic counts receive cyclophosphamide IV, oral dexamethasone, etoposide IV, and cisplatin IV for 4 days. On day 3 of continuous infusions, gemcitabine is given over 100 minutes. At 6 and 12 months after autotransplant, patients receive oral dexamethasone on days 1-4, paclitaxel IV over 6 hours on day 2, and cisplatin IV over 24 hours on day 3. Patients are followed every 6 weeks to 3 months until death. PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued within 2.5 years.
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 18 to 70 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 proven multiple myeloma with greater than 12 months of prior therapy Bone marrow plasmacytosis at least 30% or protein criteria present No obvious myelodysplastic changes in the bone marrow No CNS disease PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (3-4 acceptable if based solely on bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4 times upper limit of normal No active or chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF greater than 50% Pulmonary: FEV1 or FVC at least 50% of predicted DLCO at least 50% of predicted Patients unable to complete pulmonary function tests must have a CT scan of the chest and acceptable arterial blood gases of PO2 greater than 70 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection requiring IV antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior steroid therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy 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
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, United StatesOpen Marlene & Stewart Greenebaum Cancer Center, University of Maryland in Google Maps