UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2019 Year 02 Month 15 Day
Date of IRB	2019 Year 02 Month 04 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
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	2022 Year 08 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040960