Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039754
Status:
TERMINATED
Last Update Posted:
2009-01-21
First Post:
2002-06-07
Brief Title:
A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients With Multiple Myeloma
Sponsor:
Poniard Pharmaceuticals
Organization:
Poniard Pharmaceuticals
Study Overview
Official Title:
A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
business reasons
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple myeloma is a disease that resides primarily in the bone and has shown to be sensitive to radiation Administration of a radiotherapy agent that targets the bone such as Holmium-166-DOTMP in conjunction with melphalan and an autologous stem cell transplant may improve the patients chance of responding to treatment The purpose of this study is to determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients with multiple myeloma
Detailed Description:
The purpose of this study is to estimate the radiation absorbed dose to the bone marrow and kidneys based on whole-body gamma camera image data for comparison with that obtained using mathematical models based on whole body counting from a small gamma detection device called a thyroid probe to obtain pharmacokinetic data following administration of 166Ho-DOTMP and to evaluate safety and efficacy in patients who receive 25 Gy targeted therapy of 166Ho-DOTMP and 200 mgm2 melphalan followed by autologous peripheral blood stem cell transplant PBSCT
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