An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
- 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)
- 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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity (Phase I)
Angela Dispenzieri, M.D.
United States: Federal Government
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