Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004903
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Robert H Lurie Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of High Dose Late Intensification Therapy in Patients With Chemotherapy Sensitive Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 combination chemotherapy and peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES I Determine the feasibility and activity of intensive therapy with 3 noncross resistant chemotherapeutic regimens cyclophosphamide etoposide cisplatin cytarabine and tandem courses of high dose melphalan with stem cell rescue in patients with chemotherapy sensitive multiple myeloma II Determine the incidence of hematologic and nonhematologic toxicities of this regimen in this patient population III Determine the time to hematologic recovery after high dose melphalan in these patients IV Determine the response rate after each course of therapy in these patients V Determine the disease free relapse free and overall survival of these patients treated on this regimen VI Determine the incidence of toxicities attributable to interferon alfa and the ability to continue interferon alfa therapy as maintenance in these patients
OUTLINE Patients are stratified according to the number of prior treatments 1 vs 2 Patients receive cyclophosphamide IV over 1 hour every 3 hours for 5 doses Filgrastim G-CSF is administered subcutaneously daily beginning 3 days after cyclophosphamide and continuing through apheresis Upon hematologic recovery peripheral blood stem cells PBSC are collected over several days After completion of the autologous stem cell harvest and hematologic recovery patients receive etoposide IV and cisplatin IV continuously over 4 days followed by cytarabine IV over 2 hours Beginning 4-6 weeks later patients receive melphalan IV over 15 minutes on 2 consecutive days At least 48 hours after the second dose of melphalan PBSC are reinfused G-CSF is administered subcutaneously daily beginning 5 days after PBSC reinfusion until hematologic recovery Patients remaining in remission after the first course of high dose melphalan receive a second course of melphalan 4 to 6 months after the first course Melphalan IV is administered as above with reinfusion of the remainder of PBSC After hematologic recovery from the second transplant patients receive interferon alfa subcutaneously 3 days weekly until relapse Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 28 patients will be accrued for this study within 3 years
OUTLINE Patients are stratified according to the number of prior treatments 1 vs 2 Patients receive cyclophosphamide IV over 1 hour every 3 hours for 5 doses Filgrastim G-CSF is administered subcutaneously daily beginning 3 days after cyclophosphamide and continuing through apheresis Upon hematologic recovery peripheral blood stem cells PBSC are collected over several days After completion of the autologous stem cell harvest and hematologic recovery patients receive etoposide IV and cisplatin IV continuously over 4 days followed by cytarabine IV over 2 hours Beginning 4-6 weeks later patients receive melphalan IV over 15 minutes on 2 consecutive days At least 48 hours after the second dose of melphalan PBSC are reinfused G-CSF is administered subcutaneously daily beginning 5 days after PBSC reinfusion until hematologic recovery Patients remaining in remission after the first course of high dose melphalan receive a second course of melphalan 4 to 6 months after the first course Melphalan IV is administered as above with reinfusion of the remainder of PBSC After hematologic recovery from the second transplant patients receive interferon alfa subcutaneously 3 days weekly until relapse Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 28 patients will be accrued for this study within 3 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-G00-1690 | None | None | None |
| NU-C94H1 | None | None | None |
| NU-94H1 | None | None | None |
| UCCRC-7071 | None | None | None |