UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021864
Receipt number R000025208
Scientific Title Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Date of disclosure of the study information 2016/05/15
Last modified on 2017/04/12 09:14:04

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Basic information

Public title

Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Acronym

Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Scientific Title

Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Scientific Title:Acronym

Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Region

Japan


Condition

Condition

Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the combination of bortezomib, low dose cyclophosphamide and G-CSF in multiple myeloma patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Successful mobilization (Single collection:>4x106/kg CD34 positive cell) rate

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive bortezomib (1.3mg/2 day4,7), cyclophosphamide (1g/m2 day1) and G-CSF (days 4-) and begin apheresis on day 8. Patients undergo apheresis for up to 2 days.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Diagnosis with multiple myeloma and eligible for 1st autologous transplantation
(2)ECOG performance status 0-2
(3)WBC >2.5x109/L, Neutrophil 1.2x109/L, Platelet count >100x109/L
(4)AST, ALT, T-Bil less than two times the upper limit of normal
(5)Serum Cr =< 2mg/dl
(6)Left ventricular ejection fraction => 50%
(7)SpO2 =>95%
(8)Voluntary written informed consent form before performance of any study-related procedure

Key exclusion criteria

(1)Patient has hypersensitivity to bortezomib, cyclophosphamide, and G-CSF.
(2)Patient has Grade =>2 peripheral neuropathy
(3)Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, cardiac amyloidosis
(4)Known interstitial Pneumonitis
(5)Uncontrolled intercurrent infection
(6)Known HBs antigen positive, HCV antibody positive
(7)Known HTLV-I antibody positive, HIV antibody positive
(8)Female patients who are pregnant and/or breastfeeding.
(9)Active gastrointestinal bleeding
(10)Serious psychiatric illness
(11)A co-morbid condition which, in the view of the investigators, renders the patient at high risk for this study

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahide Yamamoto

Organization

Tokyo Medical and Dental University

Division name

Department of Hematology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5211

Email

hide.hema@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahide Yamamoto

Organization

Tokyo Medical and Dental University

Division name

Department of Hematology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5211

Homepage URL


Email

hide.hema@tmd.ac.jp


Sponsor or person

Institute

Ochanomizu Hematology Study Group

Institute

Department

Personal name



Funding Source

Organization

NPO Ibaraki blood, tumor, palliative care study committee

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

2016 Year 05 Month 15 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

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 11 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 30 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

2016 Year 04 Month 11 Day

Last modified on

2017 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025208


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name