UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027600 |
|---|---|
| Receipt number | 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 00:17:58 |
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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
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
aikochan@muc.biglobe.ne.jp
Public contact
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
aikochan@muc.biglobe.ne.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
