Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003007
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Interferon Alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
Sponsor:
University of Tennessee
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Interferon Maintenance in Advanced Multiple Myeloma After Using High-Dose Melphalan as Myeloablative Chemotherapy A Pilot Study
Status:
COMPLETED
Status Verified Date:
2002-09
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 Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase II trial to determine the effectiveness of giving interferon alfa after chemotherapy and peripheral stem cell transplantation to patients who have stage III or stage IV multiple myeloma and who have been treated with high-dose melphalan
PURPOSE Phase II trial to determine the effectiveness of giving interferon alfa after chemotherapy and peripheral stem cell transplantation to patients who have stage III or stage IV multiple myeloma and who have been treated with high-dose melphalan
Detailed Description:
OBJECTIVES I Determine the effectiveness of interferon alfa-2b maintenance following high dose melphalan chemotherapy for patients with advanced multiple myeloma II Determine the response rate to high dose dexamethasone therapy using sequential noncrossresistant chemotherapies for patients with advanced multiple myeloma
OUTLINE Patients receive high dose dexamethasone on days 1-4 9-12 and 17-20 followed by 4 weeks rest Cyclophosphamide CTX is administered intravenously in combination with mesna following dexamethasone therapy Sargramostim GM-CSF is initiated subcutaneously 1 day later and is continued for 10 days to support stem cell collections which begin 10-14 days after CTX induction Following 4 weeks of rest melphalan L-PAM is administered over 1 hour Stem cell rescue is begun 48 hours after L-PAM therapy Three to 4 months after the first L-PAM course a second L-PAM and stem cell rescue is undertaken Interferon alfa-2b IFN-A maintenance is administered 3 times per week following bone marrow recovery from the first or second L-PAM courses Patients achieving complete remission following the first course of L-PAM may proceed directly to IFN-A maintenance Patients achieving greater than grade 3 nonhematologic toxicity or not achieving an absolute neutrophil count of greater than 1000mm3 by day 21 posttransplant are not eligible for dose escalation
PROJECTED ACCRUAL A minimum of 30 patients will be enrolled
OUTLINE Patients receive high dose dexamethasone on days 1-4 9-12 and 17-20 followed by 4 weeks rest Cyclophosphamide CTX is administered intravenously in combination with mesna following dexamethasone therapy Sargramostim GM-CSF is initiated subcutaneously 1 day later and is continued for 10 days to support stem cell collections which begin 10-14 days after CTX induction Following 4 weeks of rest melphalan L-PAM is administered over 1 hour Stem cell rescue is begun 48 hours after L-PAM therapy Three to 4 months after the first L-PAM course a second L-PAM and stem cell rescue is undertaken Interferon alfa-2b IFN-A maintenance is administered 3 times per week following bone marrow recovery from the first or second L-PAM courses Patients achieving complete remission following the first course of L-PAM may proceed directly to IFN-A maintenance Patients achieving greater than grade 3 nonhematologic toxicity or not achieving an absolute neutrophil count of greater than 1000mm3 by day 21 posttransplant are not eligible for dose escalation
PROJECTED ACCRUAL A minimum of 30 patients will be enrolled
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-V97-1263 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065577 | REGISTRY | None | None |
| BCG-5889 | None | None | None |
| INTTHERA-UTENNM-BCG-5889 | None | None | None |