NCT00005792

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

A Study of Intensive-Dose Melphalan, Topotecan, and VP-16 Phosphate (MTV) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 15 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma
• Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	etoposide phosphate	Etoposide phosphate 1363 mg/m\^2/day IV over 4 hours (total dose 2726 mg/m\^2, or 2400 mg/m\^2 etoposide equivalents), beginning 24 hours after the completion of the last infusion of topotecan Days -4, -3
DRUG	melphalan	Melphalan 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2), followed immediately by topotecan. Days -7, -6, -5
DRUG	topotecan	Topotecan 3.3 mg/m\^2/day (starting total dose = 10 mg/m\^2 for level 2) IV over 30 minutes. No topotecan will be administered on the first dose level Days -7, -6, -5
PROCEDURE	Autologous Stem Cell Rescue	reinfusion of stem cells, Day 0

Timeline

• Start date: 1998-06-02
• Primary completion: 2006-07-01
• Completion: 2018-11-01
• First posted: 2004-02-02
• Last updated: 2019-11-08

Locations

1 site across 1 country: United States