Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002630
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
1999-11-01
Brief Title:
High-Dose Melphalan Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma in First Relapse
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
HIGH-DOSE MELPHALAN CHEMOTHERAPY AND TOTAL BODY RADIATION WITH PERIPHERAL BLOOD STEM-CELL RECONSTITUTION FOR PATIENTS WITH RELAPSING MULTIPLE MYELOMA
Status:
COMPLETED
Status Verified Date:
2011-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining peripheral stem cell transplantation with chemotherapy and radiation therapy may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of high-dose melphalan plus total-body irradiation and peripheral stem cell transplantation in treating patients with multiple myeloma in first relapse
PURPOSE Phase II trial to study the effectiveness of high-dose melphalan plus total-body irradiation and peripheral stem cell transplantation in treating patients with multiple myeloma in first relapse
Detailed Description:
OBJECTIVES I Assess bone marrow reconstitution and peripheral blood cell counts of patients with multiple myeloma treated with high-dose melphalan L-PAM and total-body irradiation TBI followed by peripheral blood stem cell PBSC rescue II Assess the efficacy of intravenous L-PAM and TBI for treatment of relapsingrefractory myeloma III Assess the tolerability and toxicity of this regimen in patients with relapsing multiple myeloma IV Assess response rate and survival of relapsingrefractory patients treated with this regimen
OUTLINE Prior to entry patients will have received 3 monthly courses of standard VAD followed by PBSC collection on Regimen A those who responded to VAD continue standard VAD to best response and upon relapse on or off therapy proceed to Regimen B Patients with no response to 3 courses of VAD and those with no response to an alkylating-based regimen proceed immediately to Regimen B following PBSC collection The following acronyms are used CTX Cyclophosphamide NSC-26271 G-CSF Granulocyte Colony Stimulating Factor Amgen NSC-614629 L-PAM Melphalan NSC-8806 PBSC Peripheral Blood Stem Cells VAD VincristineDoxorubicinDexamethasone TBI Total Body Irradiation Regimen A Stem Cell MobilizationHarvest CTX G-CSF Regimen B Single-Agent Myeloablative Chemoradiotherapy with Stem Cell Rescue L-PAM TBI Co60 or linear accelerators of 4 MV or greater with PBSC
PROJECTED ACCRUAL If 9 or fewer or 20 or more responses are seen in the first 50 patients treated the study will be discontinued
OUTLINE Prior to entry patients will have received 3 monthly courses of standard VAD followed by PBSC collection on Regimen A those who responded to VAD continue standard VAD to best response and upon relapse on or off therapy proceed to Regimen B Patients with no response to 3 courses of VAD and those with no response to an alkylating-based regimen proceed immediately to Regimen B following PBSC collection The following acronyms are used CTX Cyclophosphamide NSC-26271 G-CSF Granulocyte Colony Stimulating Factor Amgen NSC-614629 L-PAM Melphalan NSC-8806 PBSC Peripheral Blood Stem Cells VAD VincristineDoxorubicinDexamethasone TBI Total Body Irradiation Regimen A Stem Cell MobilizationHarvest CTX G-CSF Regimen B Single-Agent Myeloablative Chemoradiotherapy with Stem Cell Rescue L-PAM TBI Co60 or linear accelerators of 4 MV or greater with PBSC
PROJECTED ACCRUAL If 9 or fewer or 20 or more responses are seen in the first 50 patients treated the study will be discontinued
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 |
|---|---|---|---|
| V95-0613 | OTHER | NCI CTRP | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| 928003 | OTHER | None | None |