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Sponsored by: |
Poniard Pharmaceuticals |
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Information provided by: | Poniard Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00083564 |
STR (Skeletal Targeted Radiotherapy, 166Ho-DOTMP) is an investigational radiopharmaceutical that delivers radiation directly to cancer cells in the bone and bone marrow. Conventional methods of delivering radiation therapy, such as total body irradiation, expose non-target tissues to radiation and cause serious side effects.
In contrast, STR's targeted approach to delivering radiotherapy concentrates the radiation where it is needed, and minimizes exposure of normal tissues.
STR is composed of a bone-targeting molecule, DOTMP, in a stable complex with the radionuclide holmium-166. When injected into a patient's bloodstream, STR rapidly binds to bone mineral, delivering a brief, intense dose of radiation to destroy cancer cells in the bone and marrow. The high-energy and long path-length of holmium-166 beta particles provide optimal penetration and uniform irradiation of disease sites in the marrow and bone. STR that does not bind to bone is rapidly eliminated through the urinary tract. STR treatment is followed by autologous stem cell transplantation. The short half-life of holmium-166 allows treatment on an out-patient basis, and minimizes the time required between STR administration and transplantation.
The phase III study of STR is a multi-center, randomized, controlled study, designed to evaluate the safety and efficacy of STR in patients with primary refractory multiple myeloma. These are patients who have failed to achieve at least a partial response to conventional therapy and have been undergoing treatment for less than 18 months. The trial is expected to enroll approximately 240 evaluable patients, half on the experimental arm and half on the control arm. Patients on the experimental arm will receive STR at a dose of 750 mCi/m2 plus the chemotherapy drug melphalan at 200 mg/m2, followed by autologous stem cell transplantation. Patients on the control arm will receive melphalan only, followed by transplantation. Patients on both study arms will be evaluated for response to treatment six months after transplantation, using an immunofixation assay to detect myeloma protein in patient samples. Analysis of patient samples will be conducted at a central laboratory, and blinded results will be reviewed by an independent panel of experts. The study's primary endpoint is complete response, as determined by the complete disappearance of myeloma protein at six months post-transplant.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: STR(TM) (Skeletal Targeted Radiotherapy, Holmium-166-DOTMP) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Multicenter Study to Compare the Safety and Efficacy of 166Ho-DOTMP Plus Melphalan to Melphalan Alone as Conditioning for Autologous Peripheral Blood Stem Cell Transplant in Subjects With Primary Refractory Multiple Myeloma |
Estimated Enrollment: | 240 |
Study Start Date: | March 2004 |
PRIMARY OBJECTIVE:
1.To determine the efficacy of STR (166Ho-DOTMP). The primary endpoint of this study is to compare the CR rate at 6 months post-transplant (in the absence of further therapy) in subjects with primary refractory multiple myeloma after treatment with 750 mCi/m2 166Ho-DOTMP plus 200 mg/m2 melphalan followed by autologous PBSCT to treatment with 200 mg/m2 melphalan alone followed by autologous PBSCT.
SECONDARY OBJECTIVES:
Subjects will be followed for safety assessments for 10 years or until death. Efficacy will be evaluated for up to 3 years in responding subjects, and disease relapse or progression and survival will be documented until Year 10. An analysis to estimate radiation dose to the kidney will be performed in the first 20 patients. Additionally, after 6 months of follow-up have been completed on the first 20 subjects in each arm, an analysis of the CR rate will be conducted to rule out lack of efficacy of 166Ho-DOTMP. A planned interim analysis to determine the efficacy of the treatment will be performed when 60 patients on each arm have completed 6 months of follow-up.
Enrollment on trial will continue while these interim analyses are performed. NUMBER OF SUBJECTS: Two hundred and forty subjects who meet the eligibility criteria and receive study treatment will be followed on this protocol.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within four weeks prior to enrollment.
At least one previous therapy must be a qualifying therapy that includes high dose pulsed steroids.
Exclusion Criteria:
A subject meeting any of the following criteria is not eligible for participation in the study:
Study ID Numbers: | STR 0303 |
Study First Received: | May 25, 2004 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00083564 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple myeloma Primary refractory multiple myeloma STR |
Skeletal Targeted Radiotherapy Holmium-166 166-Ho-DOTMP |
Melphalan Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Immunosuppressive Agents Multiple Myeloma Hemorrhagic Disorders Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Alkylating Agents Neoplasms, Plasma Cell |
Melphalan Immunologic Factors Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |