Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00005792|
Recruitment Status : Active, not recruiting
First Posted : February 2, 2004
Last Update Posted : October 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Plasma Cell Neoplasm||Drug: etoposide phosphate Drug: melphalan Drug: topotecan Procedure: Autologous Stem Cell Rescue||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2, 1998|
|Primary Completion Date :||July 1, 2006|
|Estimated Study Completion Date :||November 2018|
Melphalan Topotecan Etoposide VP-16 Phosphate autologous stem cell transplant
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
Other Name: TopotecanDrug: 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
Other Name: Alkeran(R)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, -5Procedure: Autologous Stem Cell Rescue
reinfusion of stem cells, Day 0
Other Name: Autologous stem cell transplant
- Incidence of mucositis [ Time Frame: 5 years ]To determine the incidence and duration of CTCAE v3, grade 3 or 4 mucositis for modified dose level four.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005792
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Daniel M. Sullivan, M.D.||H. Lee Moffitt Cancer Center and Research Institute|