Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005792
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Phase III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1749 | OTHER | National Cancer Institute | None |
| MCC-11752 | OTHER | None | None |
| IRB-4983 | OTHER | None | None |