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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002611
Receipt No. R000003185
Scientific Title Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VD (Velcade, Dexamethasone) Induction Followed by HDT With ASCT and thalidomide maintenance for Newly Diagnosed MM
Date of disclosure of the study information 2009/11/01
Last modified on 2010/10/09

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Basic information
Public title Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VD (Velcade, Dexamethasone) Induction Followed by HDT With ASCT and thalidomide maintenance for Newly Diagnosed MM
Acronym Sequential VAD and VD Followed by HDT With ASCT and Thalidomide Maintenance for NDMM
Scientific Title Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VD (Velcade, Dexamethasone) Induction Followed by HDT With ASCT and thalidomide maintenance for Newly Diagnosed MM
Scientific Title:Acronym Sequential VAD and VD Followed by HDT With ASCT and Thalidomide Maintenance for NDMM
Region
Japan

Condition
Condition Newly Diagnosed Multiple Myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary Objective is to assess the response rate of sequential VD (Velcade, Dexamethasone) induction therapy as a first line treatment for the patients with multiple myeloma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1.To assess the response rate of patients given sequential VAD and VD induction followed by high dose therapy with autologous stem cell transplantation
2.To assess the toxicities of sequential VAD and VD induction chemotherapy, high dose therapy with autologous stem cell transplantation
Key secondary outcomes

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 Drug: velcade
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
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Previously untreated newly diagnosed patients with MM (stage II-III)
2.Age 15-65
3.Eastern Cooperative Oncology Group Performance Status 0-2
4.EF > 50%, FVC and FEV > 50%, DLCO >50%
5.Platelet count 100 x 109/L (pretreatment platelet transfusion is not allowed, while transfusion during the treatment is permitted), hemoglobin 8 g/dL (Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) 1.5 x 109/L
6.Adequate liver function (bilirubin < UNL(Upper Normal Limit) x 2 and ALT/AST < UNL x 3)
7.Adequate renal function (serum creatinine < UNL x 1.5 or creatine clearance > 60 ml/min)
8.Signed the informed consent, have the will and ability to follow the protocol.
Key exclusion criteria 1. History of allergic reaction attributable to compounds containing boron or mannitol
2. Known hypersensitivity to thalidomide or dexamethasone
3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
4. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
5. Acute severe infection requiring antibiotic therapy
6. Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin)
7. Pregnancy or breastfeeding
8. Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion)
9. Previous renal transplantation
10. Recurrent deep vein thrombosis or pulmonary embolism
11. Uncontrolled diabetes mellitus
12. Receipt of extensive radiation therapy within 4 weeks ((Extensive means RT to more than 2 anatomic sites).
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Sakamaki
Organization Tokyo Metroplolitan Komagome Hospital
Division name Sub-director
Zip code
Address 3-18-22 Hinkomagome Bunkyo-ku Tokyo 1138677 Japan
TEL 03-3823-2101
Email

Public contact
Name of contact person
1st name
Middle name
Last name kazuteru ohashi
Organization Tokyo Metroplolitan Komagome Hospital
Division name Hematology Division
Zip code
Address
TEL 03-3823-2101
Homepage URL
Email k.ohashi@cick.jp

Sponsor
Institute Ochanomizu blood study committee
Institute
Department

Funding Source
Organization NPO Ibaraki blood, tumor, palliative care study committee
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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 お茶の水血液検討会

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 09 Day
Last modified on
2010 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003185

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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