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

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
JournalBiology of Blood and Marrow Transplantation
DOIs
Publication statusAccepted/In press - 2018 Jan 1

Fingerprint

Busulfan
Melphalan
Stem Cell Transplantation
Multiple Myeloma
Stomatitis
Disease-Free Survival
Prospective Studies
Transplants
Survival
Mortality
Infection
Therapeutics

Keywords

  • Autologous transplantation
  • Intravenous busulfan
  • Melphalan
  • Multiple myeloma

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

Phase 2 Study of an Intravenous Busulfan and Melphalan Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (KMM150). / Jung, Sung Hoon; Lee, Je Jung; Kim, Jin Seok; Min, Chang Ki; Kim, Kihyun; Choi, Yunsuk; Eom, Hyeon Seok; Joo, Young Don; Kim, Sung Hyun; Kwak, Jae Yong; Kang, Hye Jin; Lee, Jae Hoon; Lee, Ho Sup; Mun, Yeung Chul; Moon, Joon Ho; Sohn, Sang Kyun; Park, Seong Kyu; Park, Yong; Shin, Ho Jin; Yoon, Sung Soo.

In: Biology of Blood and Marrow Transplantation, 01.01.2018.

Research output: Contribution to journalArticle

Jung, SH, Lee, JJ, Kim, JS, Min, CK, Kim, K, Choi, Y, Eom, HS, Joo, YD, Kim, SH, Kwak, JY, Kang, HJ, Lee, JH, Lee, HS, Mun, YC, Moon, JH, Sohn, SK, Park, SK, Park, Y, Shin, HJ & Yoon, SS 2018, 'Phase 2 Study of an Intravenous Busulfan and Melphalan Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (KMM150)', Biology of Blood and Marrow Transplantation. https://doi.org/10.1016/j.bbmt.2018.01.004
Jung, Sung Hoon ; Lee, Je Jung ; Kim, Jin Seok ; Min, Chang Ki ; Kim, Kihyun ; Choi, Yunsuk ; Eom, Hyeon Seok ; Joo, Young Don ; Kim, Sung Hyun ; Kwak, Jae Yong ; Kang, Hye Jin ; Lee, Jae Hoon ; Lee, Ho Sup ; Mun, Yeung Chul ; Moon, Joon Ho ; Sohn, Sang Kyun ; Park, Seong Kyu ; Park, Yong ; Shin, Ho Jin ; Yoon, Sung Soo. / Phase 2 Study of an Intravenous Busulfan and Melphalan Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (KMM150). In: Biology of Blood and Marrow Transplantation. 2018.
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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.",
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AU - Jung, Sung Hoon

AU - Lee, Je Jung

AU - Kim, Jin Seok

AU - Min, Chang Ki

AU - Kim, Kihyun

AU - Choi, Yunsuk

AU - Eom, Hyeon Seok

AU - Joo, Young Don

AU - Kim, Sung Hyun

AU - Kwak, Jae Yong

AU - Kang, Hye Jin

AU - Lee, Jae Hoon

AU - Lee, Ho Sup

AU - Mun, Yeung Chul

AU - Moon, Joon Ho

AU - Sohn, Sang Kyun

AU - Park, Seong Kyu

AU - Park, Yong

AU - Shin, Ho Jin

AU - Yoon, Sung Soo

PY - 2018/1/1

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N2 - 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.

AB - 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.

KW - Autologous transplantation

KW - Intravenous busulfan

KW - Melphalan

KW - Multiple myeloma

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