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High-Dose ¹⁶⁶Ho-DOTMP in Myeloablative Treatment of Multiple Myeloma: Pharmacokinetics, Biodistribution, and Absorbed Dose Estimation

¹ Department of Radiology, University of Washington, Seattle, Washington
² Fred Hutchinson Cancer Research Center, Seattle, Washington
³ NeoRx Corporation, Seattle, Washington

Thirty-two patients with multiple myeloma were treated with high doses of ¹⁶⁶Ho-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetramethylene-phosphonic acid (DOTMP) and were a subset of patients enrolled in a multicenter phase I/II dose escalation myeloablative trial. ¹⁶⁶Ho with ß-emission (half-life, 26.8 h; ß-particle energies, 1.85 MeV [51%] and 1.77 MeV [48%]; -photons, 80.6 keV [6.6%] and 1.38 MeV [0.9%]) was complexed to DOTMP, a macrocyclic tetraphosphonate. Pharmacokinetics, dosimetry, and biodistribution were studied. Methods: Patients were treated at escalating dose levels of 20, 30, and 40 Gy to the bone marrow in combination with high-dose melphalan, with or without total-body irradiation, to evaluate toxicity and efficacy. After infusion with 1,110 MBq (30 mCi) of ¹⁶⁶Ho-DOTMP for evaluation of biodistribution and dosimetry calculation, patients received the calculated amount of radioactivity for therapy in a single administration based on estimated dose calculations. Results: Thirty-two patients participated in the study and were then treated. The average amount of administered radioactivity was 74.3 GBq (2,007 mCi) (range, 21.5–147.5 GBq [581–3,987 mCi]) of ¹⁶⁶Ho-DOTMP. Conclusion: ¹⁶⁶Ho-DOTMP has physical and pharmacokinetic characteristics compatible with high-dose myeloablative treatment of multiple myeloma.

Key Words: ß-emitters • radionuclide therapy • myeloablation • dosimetry • myeloma

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