Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
Condition: Multiple Myeloma and Plasma Cell Neoplasm; Pain
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Pamidronate; Zoledronic acid; Sm 153 lexidronam
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 90 mg by IV monthly.; 4 mg by IV monthly.; 0.5 mCi/kg or 1 mCi/kg by IV.
Other intervention name(s): Aredia; Zometa; Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).
Intervention MeSH terms: Zoledronic Acid; Pamidronate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma; pain