UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study to examine the safety of combination with selective COX2 inhibitor meloxicam before autologous peripheral blood stem cell harvest and the collection efficiency of hematopoietic stem cells
Title of the study (Brief title)	The safety of meloxicam before autologous PBSCH and the collection efficiency of hematopoietic stem cells
Region	Japan

Condition
Condition	Patients with multiple myeloma who receive autologous peripheral blood stem cell harvest
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the safety of combination with selective COX2 inhibitor meloxicam before autologous peripheral blood stem cell harvest and the collection efficiency of hematopoietic stem cells
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative incidence and severity of bleeding, gastrointestinal ulcer and renal dysfunction and analgesic effect
Key secondary outcomes	The collection efficiency of hematopoietic stem cells

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 are administered meloxicam 10 mg once per day from the 10th day after the administration of the anticancer drug until 2 days before apheresis
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)Patients who receive their first autologous peripheral blood stem cell harvest 2)Patients who are eligible for apheresis 3)Written informed consent
Key exclusion criteria	1)Patients who are not eligible for apheresis 2)Allergy to meloxicam 3)Patients who cannot take medicine orally on the 10th day after the administration of the anticancer drug 4)Patients with bleeding tendency before treatment 5)Patients who are difficult to maintain platelets more than 20,000/mm3 even if appropriate measures such as platelet transfusion are done 6)Patients with active gastrointestinal ulcer 7)Patients with severe renal dysfunction (G3b or more in GFR classification) 8)Patients with aspirin-induced asthma or a history of aspirin-induced asthma 9)Inadequate condition as diagnosed by primary physician
Target sample size	5

Research contact person
Name of lead principal investigator	Aiko Igarashi
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name	Hematology division
Address	3-18-22 Honkomagome, Bunkyo-ku,Tokyo 113-8677, Japan
TEL	03-3823-2101
Email	aikochan@muc.biglobe.ne.jp

Public contact
Name of contact person	Aiko Igarashi
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name	Hematology division
Address	3-18-22 Honkomagome, Bunkyo-ku,Tokyo 113-8677, Japan
TEL	03-3823-2101
Homepage URL
Email	aikochan@muc.biglobe.ne.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
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	2017 Year 06 Month 02 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 08 Day
Anticipated trial start date	2016 Year 07 Month 01 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	2017 Year 06 Month 02 Day
Last modified on	2017 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031632