UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002442
Receipt number 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 14:45:23

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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 or person

Institute

Division of Hematology, Saitama Medical Center, Jichi Medical University

Institute

Department

Personal name



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

Value
https://center6.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