Multiple Myeloma Clinical Trial
Official title:
A Phase I Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients 65 Years of Age or Older, or With Renal Insufficiency Undergoing Autologous Transplantation
Two main objectives of the study are:
Primary:
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.
Secondary:
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.
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.
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