NCT00434161 - A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma | Biotech Hunter

Enrollment

281

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

March 31, 2009

Study Completion Date

May 31, 2012

Conditions

Multiple Myeloma

Interventions

DRUG

Palifermin before only

One bolus IV injection at 60 μg/kg/day, on Days 6, 5 \& 4 days before-high dose chemotherapy and one bolus IV injection at 60 μg/kg/day of matched placebo on days 0, 1 \& 2 days after-high dose chemotherapy. Minimum of 4 days between before-chemotherapy and after-transplantation dosing.

DRUG

Placebo

"One bolus IV injection at 60 μg/kg/day of matched placebo on Days 6, 5 \& 4 (before-high dose chemotherapy) and on Days 0, 1 \& 2 (after-high dose chemotherapy).~Minimum of 4 days between pre-chemotherapy and post-transplantation dosing."

DRUG

Palifermin before and after

"One bolus IV injection at 60 μg/kg/day, on Days 6, 5 \& 4 (before-high dose chemotherapy) and on Days 0, 1 \& 2 (after-high dose chemotherapy).~Minimum of 4 days between before-chemotherapy and after-transplantation dosing."

Trial Locations (1)

Unknown

Universitatsklinikum Leipzig, Leipzig