UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase 2 study
Title of the study (Brief title)	JSCT-MM16
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 new drugs in each phase of treatment in patients with newly diagnosed symptomatic multiple myeloma, and to investigate efficacy of detection of minimal residual disease (MRD). Induction therapy: bortezomib, lenalidomide, and dexamethasone (VRD). Conditioning regimen in autologous stem cell transplantation: bortezomib and high-dose melphalan. Consolidation therapy: carfilzomib, lenalidomide, and dexamethasone (KRD). Maintenance therapy: lenalidomide (until-PD).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete response (CR) rates 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 Treatment Failure (TTF) 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	Uncontrolled
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) scBor 1.3mg/m2 day1,4,8,11 + Len 25mg/body day1-14 + Dex 40mg/body day1,4,8,11 PBSC harvest scBor 1.3mg/m2 day1,4,8,11 + CY 1.5g/m2 day8,9 + G-CSF High dose chemotherapy and PBSCT scBor 1.3mg/m2 day-4,-1,3,6 + HD-Mel 100mg/m2 day-3,-2 PBSCT day0 Consolidation therapy (4 courses, every 4 weeks) Cfz 20/27mg/m2 day1,2,8,9,15,16 + Len 25mg/body day1-21 + Dex 40mg/body day1,8,15 Maintenance therapy (every 4 weeks until PD) Len 10mg/day day1-21 until-PD
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. Age from 20 to 65 years old. 2. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). 3. Measureable M protein in serum or urine or abnormal serum kappa/lambda ratio by the serum free light chain measurement. 4. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.) 5. Main Organ function is maintained 6. Those who are evaluated to be able to survive more than 3 months. 7. 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 according to the proposal of RevMate. For male patients, to agree the appropriate method of contraception during the study according to the proposal of RevMate. 8. 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	133

Research contact person
Name of lead principal investigator	Toshihiro Miyamoto
Organization	Kyushu University Graduate School of Medical Science
Division name	Department of Medicine and Biosystemic Science
Address	Fukuoka, Japan
TEL	092-
Email	jsct-office@umin.ac.jp

Public contact
Name of contact person	Toshihiro Miyamoto
Organization	JSCT
Division name	MM16 DC
Address	104-0031
TEL	03-6225-2025
Homepage URL
Email	jsct-office@umin.ac.jp

Sponsor
Institute	JSCT
Institute
Department

Funding Source
Organization	CELGENE K.K. ONO PHARMACEUTICAL CO., LTD.
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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 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	2016 Year 09 Month 26 Day
Last modified on	2017 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027823