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Biol Blood Marrow Transplant. 2018 May;24(5):923-929. doi: 10.1016/j.bbmt.2018.01.004. Epub 2018 Jan 12.

Phase 2 Study of an Intravenous Busulfan and Melphalan Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (KMM150).

Author information

1
Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, Republic of Korea.
2
Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, Republic of Korea. Electronic address: drjejung@chonnam.ac.kr.
3
Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: hemakim@yuhs.ac.
4
Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University of Korea, Seoul, Republic of Korea.
5
Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Seoul, Republic of Korea.
6
Departmenrt of Internal Medicine, Ulsan University Hospital, Ulsan, Republic of Korea.
7
Department of Hematology-Oncology, National Cancer Center, Goyang-si, Republic of Korea.
8
Department of Hematology-Oncology, Inje University Busan Paik Hospital, Busan, Republic of Korea.
9
Department of Hematology-Oncology, Dong-A Medical Center, Busan, Republic of Korea.
10
Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Republic of Korea.
11
Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.
12
Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Republic of Korea.
13
Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.
14
Department of Internal Medicine, Ewha Woman's University School of Medicine, Seoul, Republic of Korea.
15
Departmen of Hematology-Oncology, Kyungpook National University Hospital, Daegu, Republic of Korea.
16
Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.
17
Division of Hematology-Oncology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
18
Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea.
19
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.

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

PMID:
29339269
DOI:
10.1016/j.bbmt.2018.01.004
[Indexed for MEDLINE]
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