Clinical trial NCT00784823
Conditions: Multiple Myeloma
Sponsor: Hackensack Meridian Health
Start date: 2007-01-01; Completion date: 2013-12-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief 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.

Arms: arm 1: Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. arm 2: Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. arm 3: Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2. arm 4: Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Interventions: intervention 1: Bortezomib 1 mg/m2 intervention 2: Bortezomib 1.3 mg/m2 intervention 3: Bortezomib 1.6 mg/m2 intervention 4: Melphalan
Intervention descriptions: intervention 1: * 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 intervention 2: * 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 intervention 3: * 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 intervention 4: * 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

Protocol documents: