Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating 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.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: Zoledronic acid
Radiation: Sm 153 lexidronam
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain|
- Toxicity (Phase I) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Confirmed clinical response of serum and urine monoclonal protein (Phase II) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Response (Phase I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Bone pain response (Phase II) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Toxicity (Phase II) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
|Experimental: Sm 153 lexidronam||
90 mg by IV monthly.
Other Name: ArediaDrug: Zoledronic acid
4 mg by IV monthly.
Other Name: ZometaRadiation: Sm 153 lexidronam
0.5 mCi/kg or 1 mCi/kg by IV.
Other Name: Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).
- 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 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482378
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Angela Dispenzieri, M.D.||Mayo Clinic|