A Phase 1 interventional study of Busulfan in Multiple Myeloma, sponsored by Guido Tricot. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.
Sponsored by Guido Tricot · Phase 1, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Guido Tricot is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Busulfex given to patients who are either ≥65 years or have renal insufficiency
Drug: Busulfan
Busulfan (Bu) is a bifunctional alkylating agent currently used almost exclusively as a component of conditioning regimens for both autologous and allogeneic stem-cell transplants.
Also known as: Busulfex ®
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Guido Tricot