Phase 2 Study of an Intravenous Busulfan and Melphalan Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (KMM150)
Sung-Hoon Jung, Je-Jung Lee, Jin Seok Kim, Chang-Ki Min, Kihyun Kim, Yunsuk Choi, Hyeon-Seok Eom, Young Don Joo, Sung-Hyun Kim, Jae-Yong Kwak, Hye Jin Kang, Jae Hoon Lee, Ho Sup Lee, Yeung-Chul Mun, Joon Ho Moon, Sang Kyun Sohn, Seong Kyu Park, Yong Park, Ho-Jin Shin, Sung-Soo Yoon, Korean Multiple Myeloma Working Party, Sung-Hoon Jung, Je-Jung Lee, Jin Seok Kim, Chang-Ki Min, Kihyun Kim, Yunsuk Choi, Hyeon-Seok Eom, Young Don Joo, Sung-Hyun Kim, Jae-Yong Kwak, Hye Jin Kang, Jae Hoon Lee, Ho Sup Lee, Yeung-Chul Mun, Joon Ho Moon, Sang Kyun Sohn, Seong Kyu Park, Yong Park, Ho-Jin Shin, Sung-Soo Yoon, Korean Multiple Myeloma Working Party
Abstract
This prospective study evaluated the efficacy and toxicity of intravenous busulfan and melphalan as a conditioning regimen for autologous stem cell transplantation (ASCT) in patients with multiple myeloma (MM). A total of 99 patients with MM, enrolled between January 2013 and March 2016, received intravenous busulfan (9.6 mg/kg) and melphalan (140 mg/m2) before ASCT. The median time to transplant was 6.2 months, and 90 (90.9%) patients underwent ASCT within 12 months of the diagnosis. The overall response rate after ASCT was 94.0%, including 43.5% with a stringent complete response/complete response, 27.3% with very good partial response, and 23.2% with partial response. The most common severe nonhematologic toxicity (grade 3 to 4) was infection (26.3%) and stomatitis (15.2%). Three (3.2%) patients developed veno-occlusive disease. No treatment-related mortality was observed. After a median follow-up of 26.1 months, the median progression-free survival was 27.2 months (range, 13.0 to 41.4 months) and median overall survival was not reached. In conclusion, a conditioning regimen of intravenous busulfan and melphalan was effective and tolerable. ClinicalTrials.gov. number: NCT01923935.
Keywords: Autologous transplantation; Intravenous busulfan; Melphalan; Multiple myeloma.
Copyright © 2018 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
Source: PubMed