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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027600
Receipt No. R000031632
Scientific Title 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
Date of disclosure of the study information 2017/06/02
Last modified on 2017/06/02

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Basic information
Public title 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
Acronym The safety of meloxicam before autologous PBSCH and the collection efficiency of hematopoietic stem cells
Scientific Title 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
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Aiko Igarashi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name Hematology division
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo 113-8677, Japan
TEL 03-3823-2101
Email aikochan@muc.biglobe.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Aiko Igarashi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name Hematology division
Zip code
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)

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
2017 Year 06 Month 02 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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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