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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035970
Receipt No. R000040960
Scientific Title The efficacy of combination of Olanzapine, Aprepitant, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving autologous peripheral blood stem cell transplantation for multiple myeloma
Date of disclosure of the study information 2019/02/25
Last modified on 2019/02/21

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Basic information
Public title The efficacy of combination of Olanzapine, Aprepitant, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving autologous peripheral blood stem cell transplantation for multiple myeloma
Acronym The efficacy of Olanzapin for PBSCT
Scientific Title The efficacy of combination of Olanzapine, Aprepitant, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving autologous peripheral blood stem cell transplantation for multiple myeloma
Scientific Title:Acronym The efficacy of Olanzapin for PBSCT
Region
Japan

Condition
Condition multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of combination of Olanzapine, Aprepitant, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving autologous peripheral blood stem cell transplantation for multiple myeloma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete response rate for the delayed phase (24-120 hours), defined as no emetic episodes and no use of rescue medication
Key secondary outcomes Complete response rate for the acute phase (0-24 hours) and the overall phase (0-120 hours). Complete control rate for the acute, delayed and overall phase.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olanzapine group
Olanzapine; 5mg PO on days 1 to 5
Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3
Palonosetron; 0.75mg IV on day 1
Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 4
Interventions/Control_2 Standard precaution proup
Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3
Palonosetron; 0.75mg IV on day 1
Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 4
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients who undergo autologous stem cell transplantation
2)ECOG-Performance Status (PS) is 0-2
3)Patients who are not allergic to Olanzapine
4)Patients who don't have a history of diabetes
5)Patient who provided written consents for this study
Key exclusion criteria 1)Uncontrolled active infection.
2)Active gastrointestinal ulcer.
3)Serious psychiatric illness.
4)Patient who is judged to be medically unfit by physician.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Misayo Shimizu
Organization Hitachi general hospital
Division name hematology,oncology
Zip code
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL 0294231111
Email misayo.hayashi.wg@hitachi.com

Public contact
Name of contact person
1st name
Middle name
Last name Misayo Shimizu
Organization Hitachi general hospital
Division name hematology,oncology
Zip code
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL 0294231111
Homepage URL
Email misayo.hayashi.wg@hitachi.com

Sponsor
Institute Hitachi general hospital
Institute
Department

Funding Source
Organization Hitachi general 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
2019 Year 02 Month 25 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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
2019 Year 02 Month 21 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040960

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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