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

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 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


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

Value
https://center6.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