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

Phase 1

Completed

• Conditions: Plasma Cell Neoplasm; Multiple Myeloma
• Interventions: Drug: etoposide phosphate; Drug: melphalan; Drug: topotecan; Procedure: Autologous Stem Cell Rescue

• Registration Number: NCT00005792
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Study Timeline

• Study Start: 1998-06-02
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2004-01-30
• Study First Posted: 2004-02-02
• Primary Completion: 2006-07-01
• Study Completion: 2018-11-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MTV	etoposide phosphate	Melphalan Topotecan Etoposide VP-16 Phosphate autologous stem cell transplant
MTV	Autologous Stem Cell Rescue	Melphalan Topotecan Etoposide VP-16 Phosphate autologous stem cell transplant
MTV	melphalan	Melphalan Topotecan Etoposide VP-16 Phosphate autologous stem cell transplant
MTV	topotecan	Melphalan Topotecan Etoposide VP-16 Phosphate autologous stem cell transplant

Primary Outcome Measures

Name	Time	Method
Incidence of mucositis	5 years	To determine the incidence and duration of CTCAE v3, grade 3 or 4 mucositis for modified dose level four.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States