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Sponsored by: |
Mayo Clinic |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00478075 |
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells.
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Bortezomib may also make cancer cells more sensitive to radiation therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Other: immunologic technique Radiation: samarium Sm 153 lexidronam pentasodium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of 153 Sm EDTMP (Quadramet™) and PS-341 (Velcade®) in Patients With Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 50 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, pilot, open-label, dose-escalation study of bortezomib followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients undergo blood sample collection at baseline and then on days 1-6 for correlative studies. Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free light chain ratio to determine the early effects of treatment.
After completion of study treatment, patients are followed weekly for 7 weeks, monthly for 3 months and then every 3 months for a total of 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Measurable or evaluable disease as defined by at least 1 of the following:
Previously treated disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior and no concurrent high-dose corticosteroids
No other concurrent systemic antineoplastic therapy including, but not limited to, any of the following:
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Angela Dispenzieri, MD | Mayo Clinic |
Investigator: | Morie A. Gertz, MD | Mayo Clinic |
Investigator: | Philip R. Greipp, MD | Mayo Clinic |
Investigator: | Suzanne Hayman, MD | Mayo Clinic |
Investigator: | Shaji K. Kumar, MD | Mayo Clinic |
Investigator: | Martha Q. Lacy, MD | Mayo Clinic |
Investigator: | John A. Lust, MD, PhD | Mayo Clinic |
Investigator: | S. V. Rajkumar, MD | Mayo Clinic |
Investigator: | Stephen J. Russell, MD, PhD | Mayo Clinic |
Investigator: | Gregory Wiseman, MD | Mayo Clinic |
Investigator: | Thomas E. Witzig, MD | Mayo Clinic |
Investigator: | Steve Zeldenrust, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Angela Dispenzieri ) |
Study ID Numbers: | CDR0000546736, MAYO-MC0585, MAYO-IRB-1586-05 |
Study First Received: | May 23, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00478075 History of Changes |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders Protease Inhibitors |
Multiple Myeloma Hemorrhagic Disorders Analgesics, Non-Narcotic Samarium ethylenediaminetetramethylenephosphonate Peripheral Nervous System Agents Analgesics Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Analgesics, Non-Narcotic Samarium ethylenediaminetetramethylenephosphonate Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents Neoplasms, Plasma Cell |