Multiple Myeloma Clinical Trial
Official title:
A Study of Intensive-Dose Melphalan, Topotecan, and VP-16 Phosphate (MTV) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating patients who have multiple myeloma.
OBJECTIVES: I. Determine the toxicity and potential efficacy of intensive high dose
chemotherapy consisting of melphalan, topotecan, and etoposide phosphate followed by
autologous stem cell transplantation in patients with stage II or III multiple myeloma or
stage I with evidence of progressive disease. II. Determine the maximum tolerated dose of
topotecan in combination with melphalan and etoposide phosphate in this patient population.
III. Determine response rates and time to treatment failure in these patients when treated
with this regimen. IV. Determine the pharmacokinetic profiles of these drugs and investigate
the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen
in these patients. V. Determine whether the sequencing of this chemotherapy regimen is
appropriate and optimal in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients are primed with
cyclophosphamide IV over 2 hours for 2 days. Peripheral blood stem cells (PBSC) are
collected. Approximately 4 weeks after PBSC collection, patients receive melphalan IV over 30
minutes and topotecan IV over 30 minutes on days -7 to -5. Etoposide phosphate IV is
administered over 4 hours on days -4 and -3. PBSC are reinfused on day 0. Cohorts of 4-12
patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 6 of 12 patients
experience dose limiting toxicities. Patients are followed 2-3 times a week for approximately
1 month, then at 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 34-60 patients will be accrued for this study within 24-36
months.
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