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.
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.
Department of Hematology, Tokyo Medical and Dental University, Tokyo 113-0034, Japan.
Masahide
M
Yamamoto
Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo 113-8677, Japan.
Kazuteru
K
Ohashi
Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo 113-8677, Japan.
Kazuhiko
K
Kakihana
Department of Hematology, Saitama Medical University Hospital, Iruma, Saitama 350-0495, Japan.
Yuichi
Y
Nakamura
Department of Hematology, Mito Medical Center, National Hospital Organization, Mito, Ibaraki 311-3193, Japan.
Takuya
T
Komeno
Department of Clinical Oncology, Ibaraki Prefectural Central Hospital, Ibaraki Clinical Education and Training Center, University of Tsukuba Hospital, Tsukuba, Ibaraki 305-8576, Japan.
Hiroshi
H
Kojima
Biomedical Statistics and Bioinformatics Graduate School of Medicine, Kyoto University, Kyoto 606-8502, Japan.
Satoshi
S
Morita
Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo 113-8677, Japan.
Hisashi
H
Sakamaki
adverse effect; autologous peripheral blood stem-cell transplantation; dose-finding study; lenalidomide