UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035970 |
|---|---|
| Receipt number | 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 | 2022/08/24 11:19:46 |
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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
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
misayo.hayashi.wg@hitachi.com
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040960
