UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000168
Receipt number R000000239
Scientific Title Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)
Date of disclosure of the study information 2005/09/12
Last modified on 2007/06/25 19:02:17

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Basic information

Public title

Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

Acronym

Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

Scientific Title

Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

Scientific Title:Acronym

Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

Region

Japan


Condition

Condition

Multiple myeloma that refractory or relapsed for autologous stem cell transplantation

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Phase I study to evaluate the safety of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

1)Therapy related mortality at 100 days after hematopoietic stem cell transplantation 2)Engraftment rate at 100 days after hematopoietic 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

Non-myeloablative conditioning of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors

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) Refractory(except for CR and vPR) or relapse for autologus stem cell transplantation 2) Aged 20 to 65 years 3) HLA matched sibling donor 4) ECOG PS 0-2 5) Sufficient organ function 6) Written informed concent

Key exclusion criteria

1) Insulin dependent diabetes mellitus 2) Uncontrolable HT 3) Unstable angina, heart failure, or myocardial infarction 4) interstitial pneumonia or pulmonary fibrosis 5) positive HBs antigen 6) seropositive to HCV 7) seropositive to HIV 8) Severe infections 9)double cancer 10)Pregnant women 11) Sever mental disease 12) Patients inappropriate for transplantation with reasons other than above.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Morishima, M.D.,Ph.D.

Organization

Aichi Cancer Center

Division name

Department of Cell Therapy and Hematology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN

TEL

052-762-6111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takakazu Kawase, M.D.

Organization

Aichi Cancer Center

Division name

Department of Cell Therapy and Hematology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN

TEL

052-762-6111

Homepage URL

http://www.c-shot.or.jp/study/0403/outline/

Email

t-kawase@aidhi-cc.jp


Sponsor or person

Institute

Nagoya BMT Group

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

C-SHOT0403

Org. issuing International ID_1

Center for Supporting Hematology-Oncology Trials

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 12 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

Terminated

Date of protocol fixation

2004 Year 08 Month 13 Day

Date of IRB


Anticipated trial start date

2004 Year 08 Month 01 Day

Last follow-up date

2008 Year 08 Month 01 Day

Date of closure to data entry

2008 Year 08 Month 01 Day

Date trial data considered complete

2008 Year 08 Month 01 Day

Date analysis concluded

2008 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 12 Day

Last modified on

2007 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000239


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name