International Journal of Hematology

DOI: 10.1007/s12185-018-2448-9 Pages: 1-8

Bortezomib maintenance therapy in transplant-ineligible myeloma patients who plateaued after bortezomib-based induction therapy: a multicenter phase II clinical trial

1. National Hospital Organization Shibukawa Medical Center, Department of Hematology

2. Gunma Cancer Center, Department of Hematology

3. Iwate Medical University School of Medicine, Department of Medical Oncology

4. Showa Inan General Hospital, Department of Hematology

5. Yamanashi Prefectural Central Hospital, Department of Medical Oncology

6. Gunma University Graduate School of Medicine, Department of Medicine and Clinical Science

7. Niigata Cancer Center Hospital, Department of Internal Medicine

8. Iwate Prefecture Ofunato Hospital, Department of Hematology

9. National Hospital Organization Matsumoto Medical Center, Department of Hematology

10. Shinshu University School of Medicine, Division of Hematology, Department of Internal Medicine

11. Shinshu University School of Medicine, Department of Biomedical Laboratory Medicine

12. University of Yamanashi, Division of Hematology and Oncology

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

Correspondence to:
Atsushi Isoda
Tel: +81-279-23-1010
Email: aisoda@sbmc.hosp.go.jp

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Abstract

In the era of novel therapeutic agents for multiple myeloma (MM), both the significance of achieving the plateau phase and the efficacy of subsequent maintenance therapy remain unclear. In the present study, we evaluated the efficacy and safety of bortezomib maintenance therapy (biweekly for 1 year) in transplant-ineligible MM patients who plateaued after bortezomib-based induction therapy. Of 36 evaluable patients, the overall response rate during induction therapy was 61%, with a stringent complete response in 6%, a complete response in 6%, a very good partial response in 17%, and a partial response in 33%. Twenty patients achieved the plateau phase and subsequently received bortezomib maintenance therapy. Median progression-free survival from the induction and maintenance therapies was 13.8 months (95% confidence interval, 11.4–23.7 months) and 10.7 months (95% confidence interval, 3.7–10.7 months), respectively. During maintenance therapy, there were no cases with grade ≥ 2 peripheral neuropathy, nor was there any improvement in the quality of the response. In conclusion, although maintenance therapy with biweekly bortezomib for up to 1 year was feasible, plateau-oriented bortezomib induction therapy followed by bortezomib maintenance therapy was not adequate in newly diagnosed transplant-ineligible MM patients.

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