Pain Clinical Trial
Official title:
An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
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.
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.
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