A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
18 Years
70 Years
Both
Multiple Myeloma
Trial Information
A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
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 mg/m2 melphalan followed by autologous peripheral blood stem cell
transplant (PBSCT).
Inclusion Criteria
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
0102
NCT ID:
NCT00039754
Start Date:
March 2002
Completion Date:
Related Keywords:
- Multiple Myeloma
- Multiple myeloma
- Transplant
- Skeletal Targeted Radiotherapy
- Holmium
- Multiple Myeloma
- Neoplasms, Plasma Cell
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