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A Phase II study of 153 Sm‐EDTMP and high‐dose melphalan as a peripheral blood stem cell conditioning regimen in patients with multiple myeloma
Author(s) -
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 Iva.,
Ansell Stephen M.,
Porrata Luis,
Elliott Michelle A.,
Johnston Patrick B.,
Hogan William J.,
Gertz Morie A.
Publication year - 2010
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.21696
Subject(s) - medicine , melphalan , multiple myeloma , context (archaeology) , regimen , phases of clinical research , surgery , oncology , nuclear medicine , toxicity , paleontology , biology
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 153 Samarium ethylenediaminetetramethylenephosphonate ( 153 Sm‐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 153 Sm were based on dosimetry and were calculated to deliver 40 Gy to the bone marrow. The therapeutic dose of 153 Sm‐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 153 Sm‐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. 2010. © 2010 Wiley‐Liss, Inc.