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About
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.
Full description
OBJECTIVES:
Primary
Determine the safety and tolerability of samarium Sm 153 lexidronam pentasodium in combination with zoledronic acid or pamidronate disodium in patients with relapsed or refractory multiple myeloma and bone pain. (Phase I) Determine the clinical response in patients treated with these regimens. (Phase II)
Secondary
Determine the effect of these regimens on changes in patient-reported bone pain levels.
OUTLINE: This is a multicenter, open-label, pilot, phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.
Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1. Patients also receive zoledronic acid IV over 15 minutes or pamidronate disodium IV over 2-4 hours on day 1 and then monthly thereafter in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium 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.
Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I and zoledronic acid or pamidronate disodium as in phase I.
Bone pain is assessed periodically.
After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Relapsed or refractory disease, meeting 1 of the following criteria:
Measurable or evaluable disease, defined by at least 1 of the following:
Patients must have already undergone hematopoietic stem cell collection, if believed to be a transplant candidate OR not eligible for a hematopoietic stem cell transplant
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Recovered from all prior surgery, radiotherapy, or other antineoplastic therapy
More than 4 weeks since prior melphalan or other myelosuppressive agents
More than 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
More than 30 days since prior and no other concurrent investigational therapy
No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89
No concurrent external beam radiotherapy
No concurrent high-dose corticosteroids
No other concurrent medications, including any of the following:
Cytotoxic chemotherapy
Systemic antineoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
Prophylactic hematopoietic growth factors
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39 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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