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Home > "A" Clinical Trials Conditions > A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients with Multiple Myeloma  A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients with Multiple Myeloma
A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients with Multiple Myeloma
For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): NeoRx Corporation ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Diagnosis of multiple myeloma with at least 10% plasma cells in the bone marrow. Eligible to undergo autologous stem cell transplant. Have received induction therapy for treatment of myeloma. Have responsive, stable or progressive disease to induction therapy, or relapsed disease. Adequate pulmonary, cardiac, liver and renal function. No bisphosphonates or investigational agent for the treatment of myeloma in the preceding four weeks.
Total Enrollment:
Location and Contact Information:
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294
United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: 0102;
Study Start Date: March 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039754
Other Multiple Myeloma Studies:
1. Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
2. Study of the Safety and Efficacy of an Investigational Drug in Adult Patients with Multiple Myeloma
3. Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide
4. Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
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Other Multiple Myeloma Clinical Trials
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A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients with Multiple Myeloma
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