Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the tolerance and potential efficacy of combining
      dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma
      undergoing autologous stem cell transplantation.
    

Detailed description: 
      Multiple myeloma is the second most common hematological malignancy that has affected
      approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this
      disease but studies have reported improved response rates for patients who are treated with
      dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase I/II
      study will investigate the potential of combination therapy of dose-intense melphalan with
      escalating doses of bortezomib.
    

Intervention name(s): Bortezomib 1 mg/m2; Bortezomib 1.3 mg/m2; Bortezomib 1.6 mg/m2; Melphalan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen; Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen; Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen; Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
Melphalan will be given as a single dose (not split over 2 or more days)
Dosing will be based body surface area calculated using actual body weight
Other intervention name(s): Velcade; Velcade; Velcade; Alkeran
Intervention MeSH terms: Bortezomib; Melphalan
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 3 + 3 Dose Escalation
Masking: None (Open Label)
Primary purpose: Treatment