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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002442
Receipt No. R000002977
Scientific Title Targeting complete response by Upfront Bortezomib followed by Autologous transplantation and consolidataion therapy
Date of disclosure of the study information 2009/09/10
Last modified on 2018/10/02

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Basic information
Public title Targeting complete response by Upfront Bortezomib followed by Autologous transplantation and consolidataion therapy
Acronym TUBA study
Scientific Title Targeting complete response by Upfront Bortezomib followed by Autologous transplantation and consolidataion therapy
Scientific Title:Acronym TUBA study
Region
Japan

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

Objectives
Narrative objectives1 The study will be conducted to evaluate the safety and efficacy of TUBA protocol therapies (Induction therapy [high dose dexamethasone therapy, bortezomib with dexamethasone (BD) therapy], autologous stemcell transplantation, consolidation therapy [weekly BD therapy]).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of achivement of CR or more (sCR, CR) 100 days after autologous stem cell transplantation
Key secondary outcomes Distribution of all response after treatment,
The ratio of patients who complete the treatment protocol
3 year progression free survival
3 year overall survival
safety

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 (4x21-day cycles)
Bortezomib 1.3mg/m2iv day1,4,8,11
Dexamethazone 20mg/day p.o. day 1,2,4,5,8,9,11,12

Filgrastim 200ug/m2/day sc day1,2,3,4,(5),(6)
Apheresis day4,(5),(6)

High-dose phase
melphalan 100mg/m2/day iv day-2,-1
Stem cell infusion day0
Filgrastim day7-

Consolidation phase (4x 28-day cycle)
If CR is achieved by autologous stem cell transplantation, treatment will be terminated. If the effect is less than CR, the following conosolidation phase will be started at day100.
Bortezomib 1.3mg/m3 iv day1,8,15
Dexamethasone 20mg/day p.o. day1,2,8,9,15,16
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 Inclusion criteria;
1. The patients who meet the following inclusion criteria will be enrolled in this study.
2. Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria (Appendix 1) of the International Myeloma Working Group (IMWG)
3. Untreated patients without a history of pretreatment excluding local radiotherapy from pretreatment
- Patients with a lesion measurable in the evaluation of efficacy
-Patients with a quantifiable serum M protein level (generally serum M protein level >= 1.0 g/dL in terms of IgG per >=0.5 g/dL in terms of IgA)
- Patients with a urine M protein level quantifiable by electrophoresis (generally urine M protein level >=0.2 g/day)
4. Patients who are 20 to 65 years old at the time of enrollment in this study
5. Patients in good general condition (in performance status (PS) 0 to 2) (Appendix 2)
6. Patients who have the following laboratory values 14 days before provisional enrollment (N presents the upper limit of the institutional standard value)
7. Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method,
8. Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.

Key exclusion criteria Exclusion criteria
1. Patients with a past history of allergy to the drug described in the protocol
2. Patients diagnosed with smoldering myeloma or MGUS
3. Patients who cannot be expected to live for more than 3 months
4. Patients who have had a complication of active double cancer* within the past 5 years
* Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment or lesions corresponding to intramucosal carcinoma (excluding cervical carcinoma presenting in FIGO Stage I)
5. HBs antigen, HCV antibody or HIV antibody positive patients
6. Patients with grade 2 or severer peripheral neuropathy or peripheral neurogenic pain (Ctcae v3.0 JCOG/JSCO ver.)
7. Patients who have or suspected of having a serious active infection
8. Patients with serious mental disorders
9. Patients with serious pulmonary dysfunction
10. Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality (e.g., a shadow of ground-glass opacity) on CT scan (high-resolution CT) regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or a radiologist)
11. Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment
12. Patients who are complicated by poorly controlled diabetes mellitus
13. Patients who are receiving hemodialysis on account of nephropathy other than the underlying disease
14. Women who are or may be pregnant or are nursing
15. Other patients who are, in the opinion of the caring investigator, unfit for enrollment in the study

Target sample size 47

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization Saitama Medical Center, Jichi Medical Univerisity
Division name Division of Hematology
Zip code
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL 048-647-2111
Email ycanda-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiriko Terasako
Organization Saitama Medical Center, Jichi Medical Univerisity
Division name Division of Hematology
Zip code
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL 048-647-2111
Homepage URL
Email goodluck@y7.dion.ne.jp

Sponsor
Institute Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2015 Year 12 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 09 Month 03 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002977

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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