UMIN-CTR Clinical Trial

Basic information
Public title	A trial evaluating the efficacy and safety of Laftidine for protection against bortezomib-induced peripheral neuropathy.
Acronym	A trial evaluating the efficacy and safety of Laftidine for bortezomib-induced peripheral neuropathy.
Scientific Title	A trial evaluating the efficacy and safety of Laftidine for protection against bortezomib-induced peripheral neuropathy.
Scientific Title:Acronym	A trial evaluating the efficacy and safety of Laftidine for bortezomib-induced peripheral neuropathy.
Region	Japan

Condition
Condition	Multiple Myeloma
Classification by specialty	Medicine in general Hematology and clinical oncology Neurology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aim to clarify the efficacy and safety of Laftidine for protection against bortezomib-induced peripheral neuropathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was the incidence of peripheral neuropathy grade 1 with neuropathic pain and grater than Grade2 as graded by the CTCAE v. 4.0 criteria.
Key secondary outcomes

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	lafutidine was administered orally at a dose of 10 mg twice a day from the first course to the forth course of chemotherapy with Bortezomib.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed as Multiple myeloma and indicated for chemotherapy that contains bortezomib. (1.3mg/m2) 2. Patients indicated for administration of H2-receptor antagonist or proton pump inhibitors. 3. Patients older than 20 years 4. Patients without severe liver failure( AST or ALT is greater than three times the upper limit of normal) and kidney failure(estimated EGFR is less than 50ml / min) 5. Patients with performance status 0-2 6. Patients accepted the participation for this study after full explanation and understanding of the content s of this study
Key exclusion criteria	1. Patients with hypersensitivity reaction for lafutidine 2. Patients with active disease except for multiple myeloma. 3. Patients with peripheral neuropathy. 4. Patients with oral drugs that affect the neurological disorder.(Methylcobalamin, Anticonvulsants(Pregabalin, Gabapentin , Carbamazepine) , Tricyclic antidepressants( Amitriptyline, Nortriptyline, Amoxapine) ,Serotonin and norepinephrine reuptake inhibitors(Duloxetine), Antiarrhythmic drugs(Mexiletine, Flecainide) , Goshajinkigan, Shakuyakukanzoutou, etc.) 5. The patients who are receiving H2 antagonist or proton pump inhibitors, and who cannot stop these drugs. 6. Patients who require administration of Intrathecal chemotherapy. 7. Patients with severe hypersensitivity reaction for any medications. 8. Patients with HIV infection 9. Pregnant women. 10. Breast feeding women. 11. Patients who considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 12. Patients who do not agree with his or her intention 13. Patients whom the doctor recognizes unsuitable subject.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yuzuru Kanakura
Organization	Osaka University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Zip code
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	+81-6-6879-3871
Email	handai-cbc-jimu@bldon.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kenji Oritani
Organization	Osaka University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Zip code
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	+81-6-6879-3871
Homepage URL
Email	handai-cbc-jimu@bldon.med.osaka-u.ac.jp

Sponsor
Institute	Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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

大阪府立成人病センター（大阪府）：Osaka Medical Center for Cancer and Cardiovascular Diseases(Osaka) NTT西日本大阪病院（大阪府）： NTT WEST Osaka Hospital(Osaka) 県立西宮病院(兵庫県)：Hyogo Prefectural Nishinomiya Hospital(Hyogo) 大手前病院（大阪府）：Otemae Hospital(Osaka) 市立芦屋病院（兵庫県）：Ashiya Municipal Hospital(Hyogo) 市立池田病院（大阪府）：Ikeda City Hospital(Osaka) 市立伊丹病院（大阪府）：Itami City Hospital(Osaka) 堺市立総合医療センター（大阪府）：Sakai City Medical Center(Osaka) 市立吹田病院（大阪府）：Suita Municipal Hospital(Osaka) 市立豊中病院（大阪府）：Toyonaka Municipal Hospital(Osaka) 住友病院（大阪府）：Sumitomo Hospital(Osaka) 日生病院（大阪府）：Nissay Hospital(Osaka) 市立箕面病院（大阪府）：Minoh City Hospital(Osaka) りんくう総合医療センター（大阪府）：Rinku General Medical Center(Osaka) 八尾市立病院（大阪府）：Yao Municipal Hospital(Osaka) 関西労災病院（兵庫県）：Kansai Rosai Hospital(Hyogo) 国立病院機構大阪医療センター（大阪府）： National Hospital Organization Osaka National Hospital(Osaka) 医療法人川崎病院（兵庫県）：Kobe Kawasaki Hospital(Hyogo) 市立川西病院（大阪府）：Kawanishi City Hospital(Osaka)

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 26 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	2016 Year 04 Month 26 Day
Date of IRB	2016 Year 03 Month 08 Day
Anticipated trial start date	2016 Year 05 Month 23 Day
Last follow-up date	2019 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	2016 Year 04 Month 26 Day
Last modified on	2019 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024918