Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Multiple Myeloma
Interventions
PROCEDURE

Fractionated Stem Cell Infusions

Following enrollment patients will be treated with melphalan intravenously (IV) through a central venous catheter (CVC) over 30 minutes at 200mg/m2 or 140mg/m2 (if creatinine clearance is \< or = to 50 and/or age \> 70 years) on day -2. Following 24 hours of rest, the first dose of CD34+ stem cell will be administered on day 0 (2.5-5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg), followed by 3 additional doses of CD 34+ stem cells (1.5-2.5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg) on days +2, +4, and +6. Pegfilgrastim 6μg will be administered on day +1. Filgrastim 5μg/kg will be 12-24 hours after the 2nd-4th stem cell infusions. There will be a +/- 1 day window for the Day +2, +4, and +6 infusions to accommodate infusions that occur over the weekend or on holidays.

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01416246 - Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant | Biotech Hunter | Biotech Hunter