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| Sponsored by: |
Poniard Pharmaceuticals |
|---|---|
| Information provided by: | Poniard Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00039754 |
Purpose
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 patient's 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Holmium-166-DOTMP |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study |
| Official Title: | A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma |
| Study Start Date: | March 2002 |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations More Information
| Study ID Numbers: | 0102 |
| Study First Received: | June 7, 2002 |
| Last Updated: | January 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039754 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple myeloma Transplant Skeletal Targeted Radiotherapy Holmium |
|
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |
