UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of intensified induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma: a phase2 study
Title of the study (Brief title)	JSCT-MM14
Region	Japan

Condition
Condition	Multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate efficacy and safety of novel agents in each phase of treatment in patients with newly diagnosed multiple myeloma, and to investigate efficacy of detection of minimal residual disease (MRD).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Probability of CR after consolidation therapy.
Key secondary outcomes	1. CR + stringent CR (sCR) rates after induction therapy. 2. CR + sCR rates after autologous stem cell transplantation. 3. sCR rates after consolidation therapy. 4. CR + sCR rates after maintenance therapy. 5. 3-years progression free survival (PFS) 6. 3-years overall survival (OS) 7. 3-years time to progression (TTP) 8. Incidence of adverse events. 9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy. 10. Detection of minimal residual disease (MRD) in autologous grafts.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Induction therapy (4 courses, every 3 weeks):Bortezomib 1.3mg/m2 sc (day1,4,8,11), cyclophosphamide 500mg/m2 iv (day1, 8), dexamethasone 40mg/day po (day 1,4,8, 11). PBSC harvest: Bortezomib 1.3mg/m2 sc (day1, 4, 8, 11). Cyclophosphamide 1.5g/m2 div (day 8, 9). G-CSF High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 sc (day-4,-1,3,6). HD-melphalan 100mg/m2 div (day -3,-2). PBSCT (day 0) Consolidation therapy (2 courses, every 4 weeks): Bortezomib 1.3mg/m2 sc (day1, 8, 15), lenalidomide 25mg/body po (day1-21), and dexamethasone 40mg/day po (day1, 8, 15,22). Maintenance therapy (every 4 weeks until PD): Lenalidomide 10mg/day po (day 1 to 21)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). Age from 20 to 65 years old. 2. Measureable M protein in serum or urine or abnormal serum k/l ratio by the serum free light chain measurement. 3. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.) 4. Main Organ function is maintained 5. Those who are evaluated to be able to survive more than 3 months. 6. For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study. 7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by having been obtained.
Key exclusion criteria	1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia. 2. Patients with amyloidosis. 3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study. 4. Patients who received prednisolone more than 30mg/day within 14 days before participation. 5. Involvement of central nervus system with myeloma cells 6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative). 7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 8. Patients with a history of active malignancy during the past 5 years. 9. Patients with psychiatric disorders such as schizophrenia etc. 10. Pregnant women, pre-menopausal women, and lactating women. 11. History of hypersensitivity to mannitol or boron. 12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary 13. Those who are considered as inappropriate to register by attending physicians.
Target sample size	53

Research contact person
Name of lead principal investigator	Kazutaka Sunami
Organization	National Hospital Organization Okayama Medical Center
Division name	Division of Hematology
Address	Okayama, Japan
TEL	086-294-9911
Email	jsct-office@umin.ac.jp

Public contact
Name of contact person	Kazutaka Sunami
Organization	JSCT
Division name	MM14 datacenter
Address	3-3-13,Kyobashi,Chuou-ku,Tokyo,Japan
TEL	03-6225-2025
Homepage URL
Email	jsct-office@umin.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Celgene Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

札幌医科大学附属病院　腫瘍･血液内科 北海道がんセンター　血液内科 北海道大学病院　血液内科 市立札幌病院　血液内科 市立函館病院　血液内科 秋田大学医学部附属病院　輸血部･血液内科 仙台医療センター　血液内科 宮城県立がんセンター　血液内科 山形県立中央病院　血液内科 新潟大学大学病院　血液・内分泌・代謝内科 群馬大学医学部附属病院　血液内科 西群馬病院　血液内科 東京医科大学病院　血液内科 東京女子医科大学病院　血液内科 埼玉医科大学総合医療センター　血液内科 近畿大学医学部　血液・膠原病内科 近江八幡市立総合医療センター　内科 京都府立医科大学附属病院　血液・腫瘍内科 京都鞍馬口医療センター　血液内科 金沢大学医学部附属病院　血液･呼吸器内科 富山県立中央病院　血液内科 富山赤十字病院　内科 JCHO 神戸中央病院　内科 兵庫県立がんセンター　血液内科 広島大学原爆放射線医科学研究所 血液･腫瘍内科 広島西医療センター　内科 山口大学医学部附属病院　第三内科 中国中央病院　血液内科 島根大学医学部附属病院　腫瘍･血液内科 島根県立中央病院　血液腫瘍科 岡山労災病院　内科 岡山医療センター　血液内科 香川大学医学部附属病院　血液･免疫･呼吸器内科 徳島県立中央病院　血液内科 高知大学医学部附属病院　血液・呼吸器内科 松山赤十字病院　内科 愛媛県立中央病院　血液内科 四国がんセンター　血液腫瘍内科 原三信病院　血液内科 福岡赤十字病院　血液腫瘍内科 九州がんセンター　血液内科 九州大学病院　血液・腫瘍内科 千早病院　内科 浜の町病院　血液内科 福岡大学病院　腫瘍・血液・感染症内科 九州医療センター　血液内科 JCHO九州病院　血液・腫瘍内科 久留米大学病院　血液・腫瘍内科 佐賀県医療センター好生館　血液内科 熊本医療センター　血液内科 鹿児島大学病院　血液膠原病内科

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 04 Day
Last modified on	2016 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019093