TY - JOUR
T1 - Thalidomide maintenance therapy in Japanese myeloma patients
T2 - a multicenter, phase II clinical trial (COMET study)
AU - Murakami, Hirokazu
AU - Kasamatsu, Tetsuhiro
AU - Murakami, Jun
AU - Kiguchi, Toru
AU - Kanematsu, Takeshi
AU - Ogawa, Daisuke
AU - Takamatsu, Hiroyuki
AU - Handa, Hiroshi
AU - Ozaki, Shuji
AU - Miki, Hirokazu
AU - Takahashi, Takeshi
AU - Takeo, Takaaki
AU - Yamauchi, Tatsuya
AU - Morishita, Takanobu
AU - Kosugi, Hiroshi
AU - Shimizu, Kazuyuki
N1 - Publisher Copyright:
© 2019, Japanese Society of Hematology.
PY - 2019/4/5
Y1 - 2019/4/5
N2 - A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.
AB - A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.
KW - Adverse events
KW - Efficacy
KW - Maintenance
KW - Multiple myeloma
KW - Thalidomide
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UR - http://www.scopus.com/inward/citedby.url?scp=85063893456&partnerID=8YFLogxK
U2 - 10.1007/s12185-019-02607-z
DO - 10.1007/s12185-019-02607-z
M3 - Article
C2 - 30701467
AN - SCOPUS:85063893456
SN - 0925-5710
VL - 109
SP - 409
EP - 417
JO - International Journal of Hematology
JF - International Journal of Hematology
IS - 4
ER -