A phase II study of Sm-153-EDTMP and high-dose melphalan as a peripheral blood stem cell conditioning regimen in patients with multiple myeloma

作者：Dispenzieri Angela^*; Wiseman Gregory A; Lacy Martha Q; Hayman Suzanne R; Kumar Shaji K; Buadi Francis; Dingli David; Laumann Krista M; Allred Jake; Geyer Susan M; Litzow Mark R; Gastineau Dennis A; Inwards David J; Micallef Ivana N; Ansell Stephen M; Porrata Luis; Elliott Michelle A; Johnston Patrick B; Hogan William J; Gertz Morie A

来源：American Journal of Hematology, 2010, 85(6): 409-413.

DOI：10.1002/ajh.21696

Multiple myeloma (MM) remains an incurable illness affecting nearly 20,000 individuals in the United States per year. High-dose melphalan (HDM) with autologous hematopoietic stem cell support (ASCT) is one of the mainstays of therapy for younger patients, but little advancement has been made with regards to conditioning regimens. We opted to combine (15)3Samarium ethylenediaminetetramethylenephosphonate (Sm-153-EDTMP), a radiopharmaceutical approved for the palliation of pain caused by metastatic bone lesions, with HDM and ASCT in a Phase II study. Individualized doses of Sm-153 were based on dosimetry and were calculated to deliver 40 Gy to the bone marrow. The therapeutic dose of Sm-153-EDTMP was followed by HDM and ASCT. Forty-six patients with newly diagnosed or relapsed disease were treated. Study patients were compared to 102 patients contemporaneously treated with HDM and ASCT. Fifty-nine percent of study patients achieved a very good partial response (VGPR) or better. With a median follow-up of 7.1 years, the median overall survival and progression free survival (PFS) from study registration was 6.2 years (95% CI 4.6-7.5 years) and 1.5 years (1.1-2.2 years), respectively, which compared favorably to contemporaneously treated non-study patients. Addition of high-dose Sm-153-EDTMP to melphalan conditioning appears to be safe, well tolerated, and worthy of further study in the context of novel agents and in the Phase III setting. Am. J. Hematol. 85:409-413, 2010.

• 出版日期2010-6