A Phase 1/2 interventional study of Pamidronate and Zoledronic acid in Multiple Myeloma and Plasma Cell Neoplasm and Pain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment
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
Secondary
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.
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.
Bone pain is assessed periodically.
After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 39 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent high-dose corticosteroids
No other concurrent medications, including any of the following:
Prophylactic hematopoietic growth factors
Drug: Pamidronate · Drug: Zoledronic acid · Radiation: Sm 153 lexidronam
90 mg by IV monthly.
Also known as: Aredia
4 mg by IV monthly.
Also known as: Zometa
0.5 mCi/kg or 1 mCi/kg by IV.
Also known as: Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).
Toxicity (Phase I)
Time frame: 12 weeks
Confirmed clinical response of serum and urine monoclonal protein (Phase II)
Time frame: 12 weeks
Response (Phase I)
Time frame: 12 weeks
Bone pain response (Phase II)
Time frame: 12 weeks
Toxicity (Phase II)
Time frame: 12 weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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