• Efficacy [ Designated as safety issue: No ]
  

Biological: filgrastim
PBSC collection: 10 mcg/kg SQ days 1-10
Biological: sargramostim

PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis

1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery

Drug: cyclophosphamide
PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
Drug: dexamethasone
40 mg/d PO days 1-4, 9-12, 17-20
Drug: melphalan
1. st trans: 140 mg/m2 IV over 20 mins day -1
2. nd trans: 200mg/m2 IV over 20 mins day -1
Drug: prednisone
maint: 50 mg/d PO every other day until progression
Drug: thalidomide
ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
Procedure: peripheral blood stem cell transplantation
2-4 x 10^6/kg IV day 0

OBJECTIVES:

• Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma.
• Determine, preliminarily, the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients.
• Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen.
• Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen.
• Evaluate immune reconstitution and recovery after first and second transplantation in these patients.

OUTLINE: This is a multicenter study.

• Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity.
• Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks, after completion of induction chemotherapy, patients receive cyclophosphamide IV over 45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11 or as soon as blood counts recover.
• First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day 0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover.
• Second transplantation: Between 2-4 months after first transplantation, patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above.
• Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral prednisone every other day and oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 months for 10 years.

PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18 months.