UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.
Title of the study (Brief title)	Shimousa MM-01 VCD study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of VCD (Velcade, cyclophosphamide and dexamethasone) therapy compared with BD (bortezomib and dexamethasone) therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	CR/VGPR rate after 4 cycles of VCD therapy
Key secondary outcomes	1) Incidence of adverse events after 4 cycles of VCD therapy 2) Efficacy of peripheral blood stem cell harvest 3) Time to progression 4) Overall survival at two years after treatment 5) Treatment efficacy at two years after treatment 6) Incidence of adverse event at two years after treatment 7) Relationship between treatment efficacy at 4 cycles of VCD treatment and progression free survival (PFS)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Velcade;(Bortezomib) 1.3 mg/m2 (s.c.) Days 1, 4, 8, 11 (cycle 1) Days 1, 8, 15, 22 (cycle 2, 3, 4) + Cyclophosphamide 500 mg/m2 (div) days 1, 8 + Dexamethasone 20 mg (p.o. or div) Days 1, 2, 4, 5, 8, 9, 11, 12 (C-1) Days 1, 2, 8, 9, 15, 16, 22, 23 (C-2, 3, 4)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Symptomatic multiple myeloma defined by IMWG criteria. 2.Measurable M protein in serum or urine 3.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.) 4.Age from 18 to 70 years old. 5.Main organ function is maintained 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.voluntary written informed consent
Key exclusion criteria	1. Non-secretory MM and plasmacell leukemia. 2. Patients with HIV antibody positive, HBs antigen posiive or HCV antibody 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. Patient was suspected pneumonia (Interstitial pneumonia). 8. Those who are considered as inappropriate to register by attending physicians.
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiro Takeuchi
Organization	Chiba University Hospital
Division name	Department of Hematology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-225-6502
Email	m-takeuchi@faculty.chiba-u.jp

Public contact
Name of contact person	Hisashi Wakita
Organization	Japanese Red Cross Society Narita Hospital
Division name	Department of hematology and Oncology
Address	90-1 Iida-cho, Narita, Japan
TEL	0476-22-2311
Homepage URL
Email	mm01vcd@gmail.com

Sponsor
Institute	Shimousa blood study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Shimousa blood study group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	千葉大学医学部附属病院（千葉県）、成田赤十字病院（千葉県）、亀田総合病院（千葉県）、旭中央病院（千葉県）、船橋中央病院（千葉県）済生会習志野病院（千葉県）、順天堂大学医学部附属浦安病院（千葉県）、金沢大学医学部附属病院（石川県）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 15 Day
Anticipated trial start date	2012 Year 11 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	2013 Year 01 Month 10 Day
Last modified on	2016 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011425