Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma

Conditions

Multiple myeloma

Muranushi H, Kanda J, Kobayashi M, Maeda T, Kitano T, Tsuji M, Ueda Y, Ishikawa T, Nohgawa M, Watanabe M, Imada K, Moriguchi T, Itoh M, Ohno H, Yonezawa A, Hirata H, Arima N, Asagoe K, Anzai N, Nagata K, Yasuno S, Kuwabara Y, Kitao H, Kim I, Kawagishi K, Ueshima K, Tominari S, Nakayama T, Yamashita K, Takaori-Kondo A.

2022-12-012 citations

10.1080/16078454.2022.2032915

Phase II Trial of Bortezomib-Based Induction, Autologous Stem Cell Transplantation, Bortezomib-Based Consolidation, and Bortezomib Maintenance in Newly Diagnosed Multiple Myeloma in Japan

Junya Kanda, Masayuki Kobayashi, Takeshi Maeda, Toshiyuki Toshiyuki, Masaaki Tsuji et al. (29 authors)

Blood2018-11-29

10.1182/blood-2018-99-113816

Interventions

Induction therapy (1st and 2nd courses) Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1-3, 8-10 ,15-17, 22-24) every 28

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1, Diagnosis of symptomatic multiple myeloma based on IMWG criteria. No prior therapy for MM. 3, Measurable M protein in serum or urin. 4, Age 20-65 years. 5, Performance status ECOG 0-2 (PS 3 possible only for osteolytic lesion). 6, Adequate organ functin. 7, Estimated life-expectancy greater than 3 months. 8, Sined, informed consent.

Exclusion criteria

Exclusion criteria: 1, Non-secretary multiplemyeloma and plasma cell leukemia 2, HIV antibody positive, HBsAg positive, HBV-DNA positive, and HCV antibody positive. 3, Known hypersensivity to mannitol or boron. 4, Pregnant or breast-feeding women. 5, Active malignancy within last 5 years. 6, Serious psychiatric disordes or illness that could potentially interfere with the completion of treatment according to this protocol. 7, Active infection or serious co-morbid medical condition. 8, Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of chest CT. 9, History of sever hypersensivity to drugs. 10,Participants who are recoginized as inadaptable for this protocol.

Design outcomes

Primary

Measure	Time frame
CR rate 100 days after autologous PBSCT	—

Secondary

Measure	Time frame
ORR after indecution therapy ORR after PBSCH ORR after 100 days after PBSCT ORR after consolidation therapy ORR during maiteinance therapy at 6, 12, 18, 24 months 2-years progression free survival 2 years overall survival Time to pregression Incidence of adverse events mCR rate after induction, PBSCH, PBSCT, consolidation and maintenance therapy Detection of Minimal residual disease in PBSCH products Numer of CD34 cells harvested Incidence of graft failure Completion rate of maintenance therapy	—

Measure

Time frame

ORR after indecution therapy ORR after PBSCH ORR after 100 days after PBSCT ORR after consolidation therapy ORR during maiteinance therapy at 6, 12, 18, 24 months 2-years progression free survival 2 years overall survival Time to pregression Incidence of adverse events mCR rate after induction, PBSCH, PBSCT, consolidation and maintenance therapy Detection of Minimal residual disease in PBSCH products Numer of CD34 cells harvested Incidence of graft failure Completion rate of maintenance therapy

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Countries

Japan

Contacts

Public ContactKobayashi Masayuki

Kyoto University Hospital Department of Hematology/Oncology

mkobayas@kuhp.kyoto-u.ac.jp075-751-3164

Outcome results

None listed