A multicenter clinical study to determine the feasible initial dose of lenalidomide for maintenance therapy in patients with multiple myeloma following autologous peripheral blood stem‑cell transplantation

Yamamoto,Masahide; Ohashi,Kazuteru; Kakihana,Kazuhiko; Nakamura,Yuichi; Komeno,Takuya; Kojima,Hiroshi; Morita,Satoshi; Sakamaki,Hisashi

doi:10.3892/mco.2016.833

A multicenter clinical study to determine the feasible initial dose of lenalidomide for maintenance therapy in patients with multiple myeloma following autologous peripheral blood stem‑cell transplantation

Authors:
- Masahide Yamamoto
- Kazuteru Ohashi
- Kazuhiko Kakihana
- Yuichi Nakamura
- Takuya Komeno
- Hiroshi Kojima
- Satoshi Morita
- Hisashi Sakamaki
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Affiliations: Department of Hematology, Tokyo Medical and Dental University, Tokyo 113‑0034, Japan, Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo 113‑8677, Japan, Department of Hematology, Saitama Medical University Hospital, Iruma, Saitama 350‑0495, Japan, Department of Hematology, Mito Medical Center, National Hospital Organization, Mito, Ibaraki 311‑3193, Japan, Department of Clinical Oncology, Ibaraki Prefectural Central Hospital, Ibaraki Clinical Education and Training Center, University of Tsukuba Hospital, Tsukuba, Ibaraki 305‑8576, Japan, Biomedical Statistics and Bioinformatics Graduate School of Medicine, Kyoto University, Kyoto 606‑8502, Japan
Published online on: March 28, 2016 https://doi.org/10.3892/mco.2016.833
Pages: 965-970

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Abstract

Maintenance therapy with lenalidomide (LEN) for patients with multiple myeloma (MM) following autologous peripheral blood stem cell transplantation (auto‑PBSCT) may be a promising option for preventing relapse or disease progression. However, the recommended dose of LEN has yet to be firmly established. We herein report the results of a multicenter clinical study for determining the feasible initial dose (FID) of LEN. In this trial, a total of 11 patients who achieved a very good partial response or complete response following auto‑PBSCT were enrolled from five transplant centers in Japan. Three dose levels of LEN (level 0, 5 mg; level 1, 10 mg; and level 2, :15 mg) were tested in this study. FID was defined as the maximum estimated dose at which 70% of the patients could receive maintenance therapy for 12 weeks without any serious adverse events or disease progression. Using a continual reassessment method, 6 patients were assigned to level 0 and the remaining 5 patients were assigned to level 1. All 6 patients (100%) at level 0, but only 2 patients (40%) at level 1, completed 12 weeks of administration with their assigned dose of LEN. The results of our study demonstrated that, although 5 mg of LEN was acceptable in terms of safety, 7.5 mg of LEN may also be an acceptable FID.

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