UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma
Title of the study (Brief title)	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	Tsutomu Sato
Organization	Sapporo Medical University Hospital
Division name	Fourth Department of Internal Medicine
Address	S-1, W-16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	tsutomus@sapmed.ac.jp

Public contact
Name of contact person	Tsutomu Sato
Organization	Sapporo Medical University Hospital
Division name	Fourth Department of Internal Medicine
Address	S-1, W-16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	tsutomus@sapmed.ac.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012007