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)
OBJECTIVES:
- 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
patients.
- 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
toxicity.
- 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
toxicity.
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
months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
5 years
No
Vaishali Sanchorawala, MD
Study Chair
Boston Medical Center
United States: Federal Government
CDR0000315382
NCT00064337
January 2004
November 2015
Name | Location |
---|---|
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 |