Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma: a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12)
Creators
- Sunami, Kazutaka1
- Matsumoto, Morio2
- Fuchida, Shin-ichi3
- Omoto, Eijiro4
- Takamatsu, Hiroyuki5
- Adachi, Yoko6
- Choi, Ilsong7
- Fujishima, Naohito8
- Kiguchi, Toru9
- Miyamoto, Toshihiro10
- Maeda, Akio11
- Suzumiya, Junji12
- Yamamura, Ryosuke13
- Nagafuji, Koji14
- Nakazato, Tomonori15
- Kuroda, Yoshiaki16
- Yujiri, Toshiaki17
- and others
- 1. National Hospital Organization Okayama Medical Center, Department of Hematology (Japan)
- 2. National Hospital Organization Shibukawa Medical Center, Department of Hematology (Japan)
- 3. Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center, Department of Hematology (Japan)
- 4. Yamagata Prefectural Central Hospital, Department of Hematology (Japan)
- 5. Pharmaceutical and Health Sciences, Kanazawa University, Department of Hematology/Respiratory Medicine, Faculty of Medicine, Institute of Medical (Japan)
- 6. Japan Community Health Care Organization Kobe Central Hospital, Department of Internal Medicine (Japan)
- 7. National Hospital Organization Kyushu Cancer Center, Department of Hematology (Japan)
- 8. Akita University Hospital, Division of Blood Transfusion (Japan)
- 9. Chugoku Central Hospital, Department of Hematology (Japan)
- 10. Kyushu University, Medicine and Biosystemic Science, Graduate School of Medical Sciences (Japan)
- 11. Hyogo Cancer Center, Department of Hematology (Japan)
- 12. Shimane University Hospital, Innovative Cancer Center/Oncology-Hematology (Japan)
- 13. Osaka Saiseikai Nakatsu Hospital, Department of Hematology (Japan)
- 14. Kurume University School of Medicine, Division of Hematology and Oncology, Department of Medicine (Japan)
- 15. Yokohama Municipal Citizen's Hospital, Department of Hematology (Japan)
- 16. Hiroshima University, Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine (Japan)
- 17. Yamaguchi University School of Medicine, Third Department of Internal Medicine (Japan)
Description
Background
The Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance.Methods
Sixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year.
Results
Complete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56%, respectively. The grade 3/4 toxicities (≥ 10%) with VCD treatment included neutropenia (27%), anemia (19%), and thrombocytopenia (11%). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64% and 88%, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group.
Conclusions
The study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.
Additional details
Identifiers
Publishing Information
- Journal Title
- International Journal of Clinical Oncology
- Journal Volume
- 24
- Journal Issue
- 8
- Journal Page Range
- p. 966-975
- ISSN
- 1341-9625
INIS
- Country of Publication
- Japan
- Country of Input or Organization
- International Atomic Energy Agency (IAEA)
- INIS RN
- 54122094
- Subject category
- S62: RADIOLOGY AND NUCLEAR MEDICINE;
- Descriptors DEI
- ANEMIAS; DEXAMETHASONE; DIAGNOSIS; ELDERLY PEOPLE; ENDOXAN; MORTALITY; PATIENTS; STEM CELLS; THERAPY; TOXICITY
- Descriptors DEC
- ADRENAL HORMONES; ADULTS; AGE GROUPS; AGED ADULTS; ALKYLATING AGENTS; ANIMAL CELLS; ANIMALS; CORTICOSTEROIDS; DISEASES; DRUGS; GLUCOCORTICOIDS; HEMIC DISEASES; HORMONES; HUMAN POPULATIONS; HUMANS; HYDROXY COMPOUNDS; IMMUNOSUPPRESSIVE DRUGS; KETONES; MAMMALS; MEDICINE; MINORITY GROUPS; ORGANIC COMPOUNDS; POPULATIONS; PREGNANES; PRIMATES; SOMATIC CELLS; STEROID HORMONES; STEROIDS; SYMPTOMS; VERTEBRATES
Optional Information
- Copyright
- Copyright (c) 2019 Japan Society of Clinical Oncology