UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011503
Receipt number R000013401
Scientific Title Intermediate-cyclophosphamide and bortezomib for peripheral blood stem cell mobilization in multiple myeloma
Date of disclosure of the study information 2013/08/19
Last modified on 2013/08/16 21:12:27

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Basic information

Public title

Intermediate-cyclophosphamide and bortezomib for peripheral blood stem cell mobilization in multiple myeloma

Acronym

IDCY-BOR PBSCH Study

Scientific Title

Intermediate-cyclophosphamide and bortezomib for peripheral blood stem cell mobilization in multiple myeloma

Scientific Title:Acronym

IDCY-BOR PBSCH Study

Region

Japan


Condition

Condition

multiple myeloma

Classification by specialty

Medicine in general Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of stem cell harvesting with intermediate-dose cyclophosphamide and bortezomib in multiple myeloma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Number of CD34 cells harvested
Safety

Key secondary outcomes

CR and CR+VGPR
Incidence of graft failure


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

Cyclophosphamide 2g/m2/day day2,3 div
Bortezomib 1.3mg/m2/day day1,4.8.11 sc
G-CSF Filgrastim 400 microgram/m2/day or Lenograstim 10microgram/kg/day

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

1.Performance status(ECOG)0-2
2.Adequate organ function
Absolute neutrophil count; no less than 1000/mm3, platelet count; no less than 75000/mm3
AST/ALT; no less than 3 times the ULN, T-Bil; no less than 2.0mg/dl
Serum creatinine; no less than 2.0mg/dl
No severe cardiac failure
PaO2; more than 60mmHg or SaO2; more than 90%
3.Complete informed concent

Key exclusion criteria

1.Uncontrollable organ dysfunction(liver dysfuction, renal insufficiency, cardiac dysfunction, respiratory dysfunction, diabetes mellitus, infection)
2.Pregnant female
3.HBsAg positive, HCVAb positive, HIVAb positive
4.Coexistence of malignancy
5.Serious mental disorders
6.Those who are considered as inappropriate to register by attending physicians

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Yamaguchi

Organization

Ishikawa Prefectural Central Hospital

Division name

Department of Hematology

Zip code


Address

2-1 Kuratsuki Higashi, Kanazawa

TEL

076-237-8211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Aiko Sawazaki

Organization

Ishikawa Prefectural Central Hospital

Division name

Department of Hematology

Zip code


Address

2-1 Kuratsuki Higashi, Kanazawa

TEL

076-237-8211

Homepage URL


Email

asawa2322@gmal.com


Sponsor or person

Institute

Department of Hematology, Ishikawa Prefectural Central Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 08 Month 19 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

2013 Year 07 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 10 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 08 Month 16 Day

Last modified on

2013 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013401


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name