S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the
      cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may
      allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
      Giving thalidomide before and after peripheral stem cell transplant may be effective in
      treating newly diagnosed multiple myeloma.

      PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and
      peripheral stem cell transplant work in treating patients with newly diagnosed multiple
      myeloma.
    

Detailed description: 
      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.
    

Intervention name(s): filgrastim; sargramostim; cyclophosphamide; dexamethasone; melphalan; prednisone; thalidomide; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): PBSC collection: 10 mcg/kg SQ days 1-10; PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis
1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery; PBSC collection: 1 mg/m2 IV over 45-60 mins day 0; 40 mg/d PO days 1-4, 9-12, 17-20; st trans: 140 mg/m2 IV over 20 mins day -1
nd trans: 200mg/m2 IV over 20 mins day -1; maint: 50 mg/d PO every other day until progression; 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; 2-4 x 10^6/kg IV day 0
Other intervention name(s): G-CSF; GM-CSF; cytoxan; decadron; steroid; thalomid; stem cell transplant
Intervention MeSH terms: Thalidomide; Dexamethasone; Prednisone; Cyclophosphamide; Melphalan; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma