Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008229
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2001-01-06
Brief Title:
Melphalan With or Without Holmium Ho 166 DOTMP Followed by 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 Multicenter Randomized Open-Label Trial Evaluating High Dose Melphalan Plus Holmium-166-DOTMP Versus High Dose Melphalan Alone When Given In Conjuction With Peripheral Blood Stem Cell Transplantation In Patients With 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radioactive drugs such as holmium Ho 166 DOTMP can kill cancer cells without harming healthy cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of melphalan with or without holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of melphalan with or without holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES I Compare the efficacy of melphalan with or without holmium Ho 166 DOTMP followed by autologous peripheral blood stem cell transplantation in patients with multiple myeloma II Compare the response rate and overall survival of these patients treated with these regimens III Compare the hematologic recovery rate and time to granulocyte engraftment of these patients treated with these regimens IV Compare the toxicity of these regimens in this patient population
OUTLINE This is a randomized open label multicenter study Patients are stratified according to their beta 2 microglobulin B2M test at initial diagnosis B2M no greater than 4 mgL vs B2M greater than 4 mgL vs unknown B2M Patients are randomized to one of two treatment arms Prior to stratification and randomization patients receive a diagnostic dose of holmium Ho 166 DOTMP within days -31 to -10 Patients with adequate skeletal uptake of the diagnostic dose are randomized for therapy Arm I Patients receive holmium Ho 166 DOTMP IV over no more than 10 minutes within days -10 to -7 at least 1 week and no more than 3 weeks after the diagnostic dose melphalan IV over 20-30 minutes within days -3 to -1 at least 24 hours prior to autologous peripheral blood stem cell PBSC transplantation and autologous PBSC transplantation on day 0 Arm II Patients receive melphalan and autologous PBSC transplantation as in arm I Following transplantation patients receive filgrastim G-CSF daily until blood counts recover Patients are followed at 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 300 patients 150 per treatment arm will be accrued for this study within 9 months
OUTLINE This is a randomized open label multicenter study Patients are stratified according to their beta 2 microglobulin B2M test at initial diagnosis B2M no greater than 4 mgL vs B2M greater than 4 mgL vs unknown B2M Patients are randomized to one of two treatment arms Prior to stratification and randomization patients receive a diagnostic dose of holmium Ho 166 DOTMP within days -31 to -10 Patients with adequate skeletal uptake of the diagnostic dose are randomized for therapy Arm I Patients receive holmium Ho 166 DOTMP IV over no more than 10 minutes within days -10 to -7 at least 1 week and no more than 3 weeks after the diagnostic dose melphalan IV over 20-30 minutes within days -3 to -1 at least 24 hours prior to autologous peripheral blood stem cell PBSC transplantation and autologous PBSC transplantation on day 0 Arm II Patients receive melphalan and autologous PBSC transplantation as in arm I Following transplantation patients receive filgrastim G-CSF daily until blood counts recover Patients are followed at 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 300 patients 150 per treatment arm will be accrued for this study within 9 months
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 |
|---|---|---|---|
| CDR0000068389 | REGISTRY | PDQ | None |
| FHCRC-154200 | None | None | None |
| NEORX-9902 | None | None | None |
| UCLA-0006110 | None | None | None |
| NCI-G00-1892 | None | None | None |