Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003401
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Multiple Myeloma
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Autologous Transplantation With Gemcitabine and High Dose BCNU Plus Melphalan Followed by Consolidation With DCEP Plus Gemcitabine and TaxolCisplatin in Patients With Multiple Myeloma and 12 Months of Standard Therapy
Status:
COMPLETED
Status Verified Date:
2019-10
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 II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have multiple myeloma that has been treated for longer than 12 months
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have multiple myeloma that has been treated for longer than 12 months
Detailed Description:
OBJECTIVES I Evaluate the complete and partial response in multiple myeloma patients receiving peripheral blood stem cells supported by gemcitabine and high dose carmustine and melphalan followed by consolidation therapy with gemcitabine plus cyclophosphamidedexamethasoneetoposidecisplatin DCEP and dexamethasonepaclitaxelcisplatin II Evaluate the incidence of early death in comparison with historical data in this patient population III Evaluate the feasibility of chemotherapy with gemcitabine plus DCEP and dexamethasonepaclitaxelcisplatin following autotransplantation in these patients
OUTLINE Patients receive gemcitabine IV over 100 minutes on day -5 and again 6 hours after administration of carmustine IV over 2 hours on day -2 followed by melphalan IV over 20 minutes on day -1 Patients receive intravenous CD34 peripheral blood stem cells on day 0 At 3 months and 9 months patients with adequate hematologic counts receive cyclophosphamide IV oral dexamethasone etoposide IV and cisplatin IV for 4 days On day 3 of continuous infusions gemcitabine is given over 100 minutes At 6 and 12 months after autotransplant patients receive oral dexamethasone on days 1-4 paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3 Patients are followed every 6 weeks to 3 months until death
PROJECTED ACCRUAL Approximately 24-63 patients will be accrued within 25 years
OUTLINE Patients receive gemcitabine IV over 100 minutes on day -5 and again 6 hours after administration of carmustine IV over 2 hours on day -2 followed by melphalan IV over 20 minutes on day -1 Patients receive intravenous CD34 peripheral blood stem cells on day 0 At 3 months and 9 months patients with adequate hematologic counts receive cyclophosphamide IV oral dexamethasone etoposide IV and cisplatin IV for 4 days On day 3 of continuous infusions gemcitabine is given over 100 minutes At 6 and 12 months after autotransplant patients receive oral dexamethasone on days 1-4 paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3 Patients are followed every 6 weeks to 3 months until death
PROJECTED ACCRUAL Approximately 24-63 patients will be accrued within 25 years
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-V98-1437 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066405 | REGISTRY | None | None |