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A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Multiple Myeloma

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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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