International Journal of Hematology

DOI: 10.1007/s12185-018-2416-4 Pages: 541-550

Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum

1. Kyoto Prefectural University of Medicine, Division of Hematology and Oncology, Department of Medicine

2. Japanese Red Cross Osaka Hospital, Department of Hematology

3. Matsushita Memorial Hospital, Department of Hematology

4. Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center, Department of Hematology

5. Kansai Medical University, First Department of Internal Medicine

6. Osaka University Graduate School of Medicine, Department of Hematology and Oncology

7. Japanese Red Cross Kyoto Daini Hospital, Department of Hematology

8. Kyoto Prefectural University of Medicine, Department of Biostatistics, Graduate School of Medical Science

9. Japanese Red Cross Kyoto Daiichi Hospital, Department of Hematology

10. Kinki University School of Medicine, Division of Hematology, Nara Hospital

11. Toyonaka Municipal Hospital, Department of Hematology

12. Nishiwaki Municipal Hospital, Department of Hematology

13. Osaka Medical Center for Cancer and Cardiovascular Disease, Department of Hematology and Oncology

14. PL General Hospital, Department of Hematology

15. Osaka Saiseikai Nakatsu Hospital, Department of Hematology

16. Kawasaki Hospital, Department of Hematology and Oncology

17. Kinki University, Division of Hematology and Rheumatology, Department of Internal Medicine, Faculty of Medicine

18. Kyoto University, Department of Hematology and Oncology

19. Osaka City University, Department of Hematology, Graduate School of Medicine

Correspondence to:
Junya Kuroda
Tel: +81-75-251-5740



Determinants of the efficacy and safety of pomalidomide (POM) monotherapy or POM plus dexamethasone (DEX) (POM/DEX) for relapsed and refractory multiple myeloma (RRMM) were examined retrospectively in a real-world clinical practice setting in Japan. The subjects were 108 patients registered with the Kansai Myeloma Forum, who were treated with either POM or POM/DEX. Of these, 79 (73%), 73 (68%), and 58 (54%) were resistant to bortezomib (BTZ), lenalidomide (LEN), and both BTZ and LEN, respectively. The median overall survival (OS) was not reached. The median time to treatment failure (TTF) was 4.4 months. The best response was recorded in 96 patients, with a 31% overall response rate (ORR) and a 79% rate of achieving at least stable disease. Number of pre-POM regimens ≥ 5, non-IgG-type M-protein, and time from initial therapy to POM or POM/DEX therapy < 2 years were associated with shorter TTF and OS. Frequent (> 10%) severe adverse events included neutropenia (55.1%), thrombocytopenia (33.7%), anemia (30.6%), febrile neutropenia (12.2%), fatigue (11.2%), and anorexia (10.2%). In conclusion, POM and POM/DEX showed substantial efficacy against RRMM, but new combination therapies with POM are needed to improve efficacy further without causing hematologic toxicities.

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