Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004158
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
1999-12-10
Brief Title:
Radiation Therapy Using Holmium Ho 166 DOTMP Plus Melphalan and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of Targeted Radiotherapy Using Holmium-166-DOTMP With Melphalan and Peripheral Blood Stem Cell Transplantation for Treatment of Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-09
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 Radiation therapy using holmium Ho 166 DOTMP may damage cancer cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells
PURPOSE Phase III trial to study the effectiveness of radiation therapy using holmium Ho 166 DOTMP plus melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Phase III trial to study the effectiveness of radiation therapy using holmium Ho 166 DOTMP plus melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of targeted radiotherapy using holmium Ho 166 DOTMP when combined with melphalan and autologous or syngeneic peripheral blood stem cell transplantation in patients with multiple myeloma II Determine the response rate and time to progression in patients treated with this regimen
OUTLINE This is a dose escalation multicenter study of targeted radiotherapy using holmium Ho 166 DOTMP Phase I Autologous or syngeneic peripheral blood stem cells PBSC are harvested and selected for CD34 cells Patients receive an initial test dose of holmium Ho 166 DOTMP IV Patients with adequate skeletal uptake of the test dose then receive therapeutic dose holmium Ho 166 DOTMP IV over 5-10 minutes for 1-3 days beginning 2 days after test dose infusion and melphalan IV over 20-30 minutes on day -3 PBSC are reinfused beginning a minimum of 24 hours after melphalan infusion and after ongoing radiation to bone marrow falls to less than 1 radhour Cohorts of 4-7 patients receive escalating doses of targeted radiotherapy using holmium Ho 166 DOTMP until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 7 patients experience dose limiting toxicity Phase II Patients receive holmium Ho 166 DOTMP at the MTD from phase I of the study Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation multicenter study of targeted radiotherapy using holmium Ho 166 DOTMP Phase I Autologous or syngeneic peripheral blood stem cells PBSC are harvested and selected for CD34 cells Patients receive an initial test dose of holmium Ho 166 DOTMP IV Patients with adequate skeletal uptake of the test dose then receive therapeutic dose holmium Ho 166 DOTMP IV over 5-10 minutes for 1-3 days beginning 2 days after test dose infusion and melphalan IV over 20-30 minutes on day -3 PBSC are reinfused beginning a minimum of 24 hours after melphalan infusion and after ongoing radiation to bone marrow falls to less than 1 radhour Cohorts of 4-7 patients receive escalating doses of targeted radiotherapy using holmium Ho 166 DOTMP until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 7 patients experience dose limiting toxicity Phase II Patients receive holmium Ho 166 DOTMP at the MTD from phase I of the study Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000067396 | REGISTRY | PDQ | None |
| FHCRC-144200 | None | None | None |
| NEORX-9804 | None | None | None |
| NCI-G99-1623 | None | None | None |