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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009750
Receipt No. R000011425
Scientific Title Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.
Date of disclosure of the study information 2013/01/15
Last modified on 2016/07/12

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Basic information
Public title Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.
Acronym Shimousa MM-01 VCD study
Scientific Title Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.
Scientific Title:Acronym 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)

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

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
1st name
Middle name
Last name Masahiro Takeuchi
Organization Chiba University Hospital
Division name Department of Hematology
Zip code
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
1st name
Middle name
Last name Hisashi Wakita
Organization Japanese Red Cross Society Narita Hospital
Division name Department of hematology and Oncology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011425

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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