S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)
- Determine overall survival of patients with high-risk multiple myeloma, primary
systemic amyloidosis, or light chain deposition disease treated with two courses of
modified high-dose melphalan and autologous peripheral blood stem cell transplantation.
- Determine the hematologic response in patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
- Determine the prognostic significance of cytogenetic markers in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease
(high-risk multiple myeloma vs primary systemic amyloidosis vs both).
- Induction therapy (multiple myeloma patients only): Patients receive oral dexamethasone
on days 1-4, 9-12, and 17-20 and oral thalidomide daily on days 1-35. Treatment repeats
every 35 days for 2 courses in the absence of disease progression or unacceptable
- Mobilization and stem cell collection:
- Multiple myeloma patients: Within 28-35 days after completion of induction
therapy, patients receive cyclophosphamide IV over 2-3 hours on day 1 and
filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 2 and continuing
through the day before the last leukapheresis. Usage of mesna IV on day 1 (prior
to and twice after cyclophosphamide administration is recommended).
- Primary systemic amyloidosis patients: Patients receive G-CSF SC daily beginning
on day 1 and continuing through the day before the last leukapheresis.
All patients undergo leukapheresis for the collection of stem cells until the target number
of CD34+ cells is reached.
- Conditioning regimen: Within 1-4 weeks after mobilization, patients receive modified
high-dose melphalan IV over 20 minutes on day -2.
- Peripheral blood stem cell (PBSC) reinfusion: PBSCs are reinfused on day 0. Patients
receive G-CSF SC daily beginning on day 1 and continuing until blood counts recover.
Patients undergo a second autologous PBSC transplantation within 3-6 months, but no later
than 12 months, after the first transplantation.
- Second conditioning regimen: Patients receive modified high-dose melphalan IV over 20
minutes on day -2.
- Second PBSC infusion: PBSCs are infused on day 0.
- Maintenance regimen (multiple myeloma patients only): Between 4-8 weeks after the
second transplantation, patients with no progressive disease receive oral dexamethasone
once daily on days 1-4 and oral thalidomide once daily on days 1-28. Courses repeat
every 28 days for 2 years in the absence of disease progression or unacceptable
Patients are followed at 3 and 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 20-25
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Vaishali Sanchorawala, MD
Boston Medical Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|CCOP - Montana Cancer Consortium||Billings, Montana 59101|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|Thompson Cancer Survival Center||Knoxville, Tennessee 37916|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Northern Rockies Radiation Oncology Center||Billings, Montana 59101|
|Hematology-Oncology Centers of the Northern Rockies - Billings||Billings, Montana 59101|
|Big Sky Oncology||Great Falls, Montana 59405|
|St. Peter's Hospital||Helena, Montana 59601|
|Glacier Oncology, PLLC||Kalispell, Montana 59901|
|Montana Cancer Center at St. Patrick Hospital and Health Sciences Center||Missoula, Montana 59802|
|Montana Cancer Specialists at Montana Cancer Center||Missoula, Montana 59802|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Mountain States Tumor Institute at St. Luke's Regional Medical Center||Boise, Idaho 83712-6297|
|Welch Cancer Center at Sheridan Memorial Hospital||Sheridan, Wyoming 82801|
|Tammy Walker Cancer Center at Salina Regional Health Center||Salina, Kansas 67401|
|Billings Clinic - Downtown||Billings, Montana 59107-7000|
|Bozeman Deaconess Cancer Center||Bozeman, Montana 59715|
|St. James Healthcare Cancer Care||Butte, Montana 59701|
|Great Falls Clinic - Main Facility||Great Falls, Montana 59405|
|Sletten Cancer Institute at Benefis Healthcare||Great Falls, Montana 59405|
|Northern Montana Hospital||Havre, Montana 59501|
|Kalispell Medical Oncology at KRMC||Kalispell, Montana 59901|
|Legacy Good Samaritan Hospital & Comprehensive Cancer Center||Portland, Oregon 97210|
|Northwest Cancer Specialists at Rose Quarter Cancer Center||Portland, Oregon 97227|
|Rocky Mountain Oncology||Casper, Wyoming 82609|
|Great Falls, Montana 59405|
|Guardian Oncology and Center for Wellness||Missoula, Montana 59804|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|