Multiple Myeloma Clinical Trial
Official title:
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)
RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer
cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral
stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and
kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving melphalan together with autologous
stem cell transplantation works in treating patients with multiple myeloma or primary
systemic amyloidosis.
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.
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