Phase 2
N=164
Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma
Multiple Myeloma · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00427765 ↗Enrolled (actual)
164
Serious AEs
18.9%
Results posted
Jan 2012
Primary outcome: Primary: Average Overall Survival Time — 3 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Busulfan (Drug); Melphalan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Overall Survival Time |
3 | — |
Summary
Primary Objectives:
1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
3. To determine the disease-free and overall survival of patients receiving this preparative regimen.
4. To determine the treatment-related morbidity and mortality of this combination of drugs.
Eligibility Criteria
Inclusion Criteria
- Patients with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and 50 ml/min and serum creatinine 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI).
- Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance score /= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
- Patients with active Central Nervous System (CNS) disease.
- Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection.
- Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.
Data sourced from ClinicalTrials.gov (NCT00427765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.