International Journal of Hematology

DOI: 10.1007/s12185-019-02607-z Pages: 409-417

Thalidomide maintenance therapy in Japanese myeloma patients: a multicenter, phase II clinical trial (COMET study)

1. Gunma University Graduate School of Health Sciences, Department of Laboratory Sciences

2. Toyama University Hospital, Department of Hematology

3. Chugoku Central Hospital, Department of Hematology

4. Nagoya University Hospital, Department of Clinical Laboratory

5. Nagasaki Prefectural Shimabara Hospital, Department of Hematology

6. Kanazawa University Hospital, Department of Hematology

7. Gunma University, Department of Hematology

8. Tokushima Prefectural Central Hospital, Department of Hematology

9. Tokushima University Hospital, Division of Transfusion Medicine and Cell Therapy

10. Gifu Municipal Hospital, Department of Hematology

11. Yokkaichi Municipal Hospital, Department of Hematology

12. Toki Municipal General Hospital, Department of Hematology

13. Japanese Red Cross Nagoya Daiichi Hospital, Department of Hematology

14. Ogaki Municipal Hospital, Department of Hematology

15. Higashi Nagoya National Hospital, Department of Hematology/Oncology

Correspondence to:
Hirokazu Murakami
Tel: +81-27-220-8973
Email: hmura@gunma-u.ac.jp

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Abstract

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.

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