UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003076
Receipt number R000003667
Scientific Title Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma
Date of disclosure of the study information 2010/02/01
Last modified on 2012/02/14 14:09:39

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Basic information

Public title

Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma

Acronym

Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma

Scientific Title

Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma

Scientific Title:Acronym

Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma

Region

Japan


Condition

Condition

relapsed and/or refractory multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this trial is to evaluate the safety (mainly, neurotoxicity) and the efficacy of 4 cycles of CBD regimen for the patients with relapsed and/or refractory multiple myeloma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

safety (neurotoxixty evaluated by FACT/GOG NTX ver. 4.0)

Key secondary outcomes

response rate as efficacy (antitumor activity) time to response, response rate after 5 more cycles, progression free survival, overall survival


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

1.The case of having no neuropathy and neural pain due to peripheral neuropaty defined using NANDA
bortezomib(BTZ):1.3mg/m2 intravenously day 1,8,15 of 21-day cycle
cyclophosphamide(CY):50mg/body orally daily
dexamethasone(DEX):20mg/cody orally on day of and day after bortezomib

2.The case of having neuropathy and neural pain due to peripheral neuropaty defined using NANDA
bortezomib(BTZ):1.0mg/m2 intravenously day 1,8,15 of 21-day cycle
cyclophosphamide(CY):50mg/body orally daily
dexamethasone(DEX):20mg/cody orally on day of and day after bortezomib

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.performance status:0-2
2.total WBC count>=3000/mm3, absolute neutrophil count>=1000/mm3, platelete count>=75000/mm3, Hb>=8.0g/dL
3.ATL and AST of less than 2.5 times the ULN, TB. od less than 1.5 times the ULN
4.serum creatinine less than 1.5times the ULN
5.nomal ECG
6.no interstitial pneumonitis
7.peripheral and neuropaty grade<=2 defined using NCI-CTCAE v3.0

Key exclusion criteria

performance status:3 and 4(excluding PS3 by bone pain and fracture)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideo Yagi

Organization

Nara Hospital Kinki University School Of Medicine

Division name

Department of Hematology

Zip code


Address

1248-1 Otsuda, Nara, 630-0293 JAPAN

TEL

0743-77-0880

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hideo Yagi

Organization

Nara Hospital Kinki University School Of Medicine

Division name

Department of Hematology

Zip code


Address

1248-1 Otsuda, Nara, 630-0293 JAPAN

TEL

0743-77-0880

Homepage URL


Email



Sponsor or person

Institute

Nara Hospital Kinki University School Of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nara Hospital Kinki University School Of Medicine

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

2010 Year 02 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

Open public recruiting

Date of protocol fixation

2009 Year 10 Month 16 Day

Date of IRB


Anticipated trial start date

2010 Year 02 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

2010 Year 01 Month 22 Day

Last modified on

2012 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name