Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
Refractory Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
Eligibility Criteria
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 Jones protein >= 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), and diffusion 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 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 complete response 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 have had 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 hours preceding amifostine treatment
Sites / Locations
- Cedars-Sinai Medical Center
- University of Rochester
- VA Puget Sound Health Care System
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (high dose melphalan, amifostine trihydrate, transplant)
Arm II (low dose melphalan, amifostine trihydrate, transplant)
INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.