UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010258
Receipt number R000012007
Scientific Title Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma
Date of disclosure of the study information 2013/03/18
Last modified on 2018/03/21 07:51:59

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Basic information

Public title

Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma

Acronym

SMUIM4-MM02

Scientific Title

Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma

Scientific Title:Acronym

SMUIM4-MM02

Region

Japan


Condition

Condition

Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of CD34 cells harvested
Toxicities

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

Bortezomib (1.3 mg/m2/day) is added to the mobilization regimen on days 1, 8, and 15, in addition to high-dose cyclophosphamide (1.5 g/m2/day) given on day 1 and 2. 400 micrograms/m2/day of filgrastim (rhG-CSF) is provided subcutaneously after the nadir value of the absolute neutrophil count until harvest. At most three times of harvest is allowed if the total number of CD34 cells does not reach 1x106/kg.

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) Good performance status (0-2). Patients with bad performance status by the osteolytic lesions can be included.
2) Age more than 20 and less than 65 years old.
3) Main Organ function is maintained.
4) Those who are evaluated to be able to survive more than 3 months.
5) In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.

Key exclusion criteria

1) Patients HIV-HBs-and HCV-positive.
2) Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
3) Patients with a history of active malignancy.
4) Patients with severe psychiatric disorders.
5) Patients with pregnancy or lactation.
6) Those who are considered as inappropriate to register by attending physicians.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Sato

Organization

Sapporo Medical University Hospital

Division name

Fourth Department of Internal Medicine

Zip code


Address

S-1, W-16, Chuo-ku, Sapporo

TEL

011-611-2111

Email

tsutomus@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Sato

Organization

Sapporo Medical University Hospital

Division name

Fourth Department of Internal Medicine

Zip code


Address

S-1, W-16, Chuo-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

tsutomus@sapmed.ac.jp


Sponsor or person

Institute

Fourth Department of Internal Medicine, Sapporo Medical University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Fourth Department of Internal Medicine, Sapporo Medical University, School of Medicine

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 03 Month 18 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

Completed

Date of protocol fixation

2013 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 18 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 03 Month 16 Day

Last modified on

2018 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name