Busulfan in Multiple Myeloma
Two main objectives of the study are:
To determine the MTD of Busulfex ® that can be given safely over the least number of days to myeloma patients who are either ≥65 years of age (Group 1) or have renal insufficiency (Group 2), defined as creatinine >3mg/dL or creatinine clearance <30 mL/min.
To perform pharmacokinetic (PK) studies to evaluate individual variability and the relationship to toxicities in each of the two groups at each proposed dose level.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients 65 Years of Age or Older, or With Renal Insufficiency Undergoing Autologous Transplantation|
- determine MTD of Busulfex given safely over least number of days patients who are either ≥65 years Group 1) or have renal insufficiency (Group 2), defined as creatinine >3mg/dL or creatinine clearance <30 mL/min. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To perform pharmacokinetic (PK) studies to evaluate individual variability and the relationship to toxicities in each of the two groups at each proposed dose level. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
This study is for first line treatment for multiple myeloma patients in patients >65 years or have renal insufficiency Busulfan introduces cytopenia much slower than melphalan while the time to recover after transplantation is the same. The duration of cytopenia with busulfan should therefore be shorter. Busulfan given in myeloma patients with renal failure has proven to be effective.
The initial proposed dose level in our study will be 3.2mg/kg of body weight over 6 hours for 3 days. The next levels will be 3.2mg/kg of body weight over 6 hours for 4 days, 4.3 mg/kg of body weight over 6 hours for 3 days, 5.6 mg/kg of body weight over 6 hours for 2 days, and 6.4 mg/kg of body weight over 6 hours for 2 days. Three patients per group will be entered at the first level. Further enrollment will be dependent upon toxicities observed. All dose escalations will be initiated after the PI has reviewed the toxicity data available on the prior dose levels and confirms that it is safe to proceed to subsequent dose level(s). Maximum tolerated dose will defined as the dose level immediately below the dose level at which ≥ 2 of 6 patients experiences a grade 4 non-hematological toxicity that is unexpected, related, and serious, and it will be evaluated separately for patients > 65 years of age or in patients with renal insufficiency.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934232
|Principal Investigator:||Guido Tricot, MD, PhD||University of Utah|