UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bortezomib, Low Dose Cyclophosphamide and G-CSF in Promoting Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Title of the study (Brief title)	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	Masahide Yamamoto
Organization	Tokyo Medical and Dental University
Division name	Department of Hematology
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	Masahide Yamamoto
Organization	Tokyo Medical and Dental University
Division name	Department of Hematology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5211
Homepage URL
Email	hide.hema@tmd.ac.jp

Sponsor
Institute	Ochanomizu Hematology Study Group
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025208