(PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older
In this study the investigators are comparing this standard regimen to the newly established
regimen of melphalan and bortezomib.
Conditioning Regimens:
Treatment arm A Melphalan is administered at a dose of 200mg/m2 by rapid intravenous
infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
Stem cell infusion:
Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of
melphalan. The infusion of peripheral blood stem cells will be done in accordance with the
Blood and Marrow Transplant program standard operating procedures.
Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day
starting on day+3 then daily starting on day 9 until engraftment (at least).
Treatment arm B
Bortezomib:
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 at
least 20 hrs after the start of the melphalan infusion on day -1.
Dosing will be based on actual body weight. Dexamethasone is administered at a dose of 20 mg
IV prior to each bortezomib infusion.
Melphalan:
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central
or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given of day-2.
Dosing will be based body surface area calculated using actual body weight
Stem cell infusion:
Stem cell infusion will occur on day 0 and will be at least 18 hours after the infusion of
the bortezomib. The infusion of peripheral blood stem cells will be done in accordance with
the Blood and Marrow Transplant program standard operating procedures.
Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day
starting on day+3 then daily starting on day 9 until engraftment (at least).
Post-transplant Supportive Care will be administered in accordance to the Blood and Marrow
Transplant program standard operating procedures.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib.
Participants will be followed post transplant for a minimum of 2 years, and after that may be monitored as part of the study indefinitely
Yes
Michele Donato, MD
Principal Investigator
John Theurer Cancer Center at Hackensack University Medical Center
United States: Food and Drug Administration
PRO# 1307
NCT01453088
June 2010
December 2013
Name | Location |
---|---|
Hackensack University Medical Center | Hackensack, New Jersey 07601 |