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 phase2 study
Title of the study (Brief title)	JSCT-MM12
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, cyclophosphamide, and dexamethasone (VCD). Conditioning regimen in autologous stem cell transplantation: bortezomib and high-dose melphalan. Consolidation therapy: bortezomib, thalidomide, and dexamethasone (VTD). Maintenance therapy: lenalidomide (one year).
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. Probability of CR + sCR after induction therapy. 2. Probability of CR + sCR after autologous stem cell transplantation. 3. Probability of sCR after consolidation therapy. 4. Probability of CR + sCR after maintenance therapy. 5. 2-years progression free survival (PFS) 6. 2-years overall survival (OS) 7. Time to progression (TTP) 8. Incidence of adverse events. 9. Probability of molecular remission (mCR) after autologous stem cell transplantation, consolidation therapy, 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 1st course: Bortezomib 1.3mg/m2 iv (day1,4,8,11), cyclophosphamide 500mg/m2 iv (day1, 8), dexamethasone 40mg/body po (day 1,4,8, 11) 2nd and 3rd courses: Bortezomib 1.3mg/m2 iv (day1,8,15,22), cyclophosphamide 300mg/m2 iv (day1,8,15,22), dexamethasone 40mg/body po (day1,8,15,22). PBSC harvest: Cyclophosphamide 1.5g/m2 div (day 1 , 2) High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 iv (day-4,-1). L-PAM 100mg/m2 div (day -3,-2). PBSCT (day 0) Consolidation therapy (2 courses): Bortezomib 1.3mg/m2 iv (day1,8,15,22), thalidomide 100mg/body p.o. (day1-35), and dexamethasone 40mg/boby (day1,8, 15, 22). Maintenance therapy (one year): Lenalidomide 10mg/body p.o. (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. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). 2. Measureable M protein in serum or urine. 3. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.) 4. Age from 20 to 65 years old. 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. For male patients, to agree the appropriate method of contraception during the study. 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 have been obtained.
Key exclusion criteria	1. Non-secretory MM and plasmacell leukemia. 2. Patients HIV-positive 3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 4. Patients with a history of active malignancy during the past 5 years. 5. Patients with psychiatric disorders such as schizophrenia etc. 6. Pregnant women, pre-menopausal women, and lactating women. 7. History of hypersensitivity to mannitol or boron. 8. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary 9. Those who are considered as inappropriate to register by attending physicians.
Target sample size	56

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
Email

Public contact
Name of contact person
Organization	JSCT
Division name	MM12 datacenter
Address
TEL
Homepage URL
Email	jsct-office@umin.ac.jp

Sponsor
Institute	Japan Study Group for Cell Therapy and Transplantation
Institute
Department

Funding Source
Organization	Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
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	2012 Year 02 Month 02 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 01 Month 24 Day
Anticipated trial start date	2012 Year 03 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 02 Day
Last modified on	2018 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008493