Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004088
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
1999-12-10
Brief Title:
Combination Chemo Peripheral Stem Cell Transplant Biological Therapy Pamidronate and Thalidomide for Multiple Myeloma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Sequential High-Dose Melphalan and BusulfanCyclophosphamide Followed by Peripheral Blood Progenitor Cell Rescue InterferonThalidomide and Pamidronate for Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2018-01
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 work in different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor Pamidronate may help to reduce the side effects of treatment for multiple myeloma
PURPOSE This phase II trial is studying combination chemotherapy peripheral stem cell transplantation biological therapy pamidronate and thalidomide to see how well they work in treating patients with stage I stage II or stage III multiple myeloma
PURPOSE This phase II trial is studying combination chemotherapy peripheral stem cell transplantation biological therapy pamidronate and thalidomide to see how well they work in treating patients with stage I stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES
Determine the feasibility and toxic effects of high-dose melphalan busulfan and cyclophosphamide followed by autologous peripheral blood stem cell rescue interferon alfa and pamidronate in patients with responsive or stable low-bulk multiple myeloma
Determine the response rate and progression-free and overall survival of patients treated with this regimen
Determine the feasibility of adding thalidomide to interferon alfa and pamidronate in patients who are not in complete remission CR 6 months after the second course of high-dose chemotherapy
Determine whether administration of thalidomide can increase the CR rate in patients who are not in CR 6 months after the second course of high-dose chemotherapy and determine its effect on progression-free and overall survival of these patients
Determine the pharmacokinetics of busulfan and cyclophosphamide and correlate the pharmacokinetics with the toxic effects of these drugs and outcome in these patients
Determine the effect of thalidomide on microvascular density of bone marrow and correlate these possible effects with outcome in these patients
Determine the cytogenetics gene rearrangement and fluorescence in situ hybridization in baseline and post treatment bone marrow and blood specimens and correlate the presencepersistence of these features with treatment outcome in these patients
OUTLINE Patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim G-CSF subcutaneously SC or IV twice a day beginning on day 2 and continuing until peripheral blood stem cells PBSCs are collected PBSCs are collected beginning on day 10
Patients receive high-dose melphalan IV on day -1 PBSCs are reinfused on day 0 G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover Between 8 and 14 weeks later patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2 PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover
Patients with responding or stable disease after chemotherapy receive maintenance therapy with interferon alfa beginning 14-20 weeks after day 0 of the second course of chemotherapy Interferon alfa is administered SC 3 times a week for 3 years Patients also receive pamidronate IV every 4 weeks until disease progression Patients who are not in complete remission CR 6 months after completing the second course of chemotherapy receive oral thalidomide daily for a maximum of 1 year or for 3 months after achieving CR
Patients are followed monthly for 1 year every 3 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within approximately 25 years
Determine the feasibility and toxic effects of high-dose melphalan busulfan and cyclophosphamide followed by autologous peripheral blood stem cell rescue interferon alfa and pamidronate in patients with responsive or stable low-bulk multiple myeloma
Determine the response rate and progression-free and overall survival of patients treated with this regimen
Determine the feasibility of adding thalidomide to interferon alfa and pamidronate in patients who are not in complete remission CR 6 months after the second course of high-dose chemotherapy
Determine whether administration of thalidomide can increase the CR rate in patients who are not in CR 6 months after the second course of high-dose chemotherapy and determine its effect on progression-free and overall survival of these patients
Determine the pharmacokinetics of busulfan and cyclophosphamide and correlate the pharmacokinetics with the toxic effects of these drugs and outcome in these patients
Determine the effect of thalidomide on microvascular density of bone marrow and correlate these possible effects with outcome in these patients
Determine the cytogenetics gene rearrangement and fluorescence in situ hybridization in baseline and post treatment bone marrow and blood specimens and correlate the presencepersistence of these features with treatment outcome in these patients
OUTLINE Patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim G-CSF subcutaneously SC or IV twice a day beginning on day 2 and continuing until peripheral blood stem cells PBSCs are collected PBSCs are collected beginning on day 10
Patients receive high-dose melphalan IV on day -1 PBSCs are reinfused on day 0 G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover Between 8 and 14 weeks later patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2 PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover
Patients with responding or stable disease after chemotherapy receive maintenance therapy with interferon alfa beginning 14-20 weeks after day 0 of the second course of chemotherapy Interferon alfa is administered SC 3 times a week for 3 years Patients also receive pamidronate IV every 4 weeks until disease progression Patients who are not in complete remission CR 6 months after completing the second course of chemotherapy receive oral thalidomide daily for a maximum of 1 year or for 3 months after achieving CR
Patients are followed monthly for 1 year every 3 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within approximately 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 |
|---|---|---|---|
| CDR0000067301 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-99021 | OTHER | None | None |
| NCI-G99-1583 | OTHER | None | None |