UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013467
Receipt No. R000015621
Scientific Title Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma
Date of disclosure of the study information 2014/03/20
Last modified on 2020/01/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma
Acronym Personalized BiRd for relapsed or refractory multiple myeloma
Scientific Title Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma
Scientific Title:Acronym Personalized BiRd for relapsed or refractory multiple myeloma
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 and safety of BiRd therapy for relapsed or refractory multiple myeloma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Best response rate
Key secondary outcomes Safety
Incidence of adverse events
Incidence of infection
Progression free survival
Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 <Personalized BiRd>
Clarithromycin 200mg x 2/day(Day1-28) p.o
Lenalidomide 5-25mg/day(Day1-21) p.o
Dexamethasone 20-40mg/day(Day1, 8, 15, 22) p.o

*VES-13(Vulnerable Elders Survey-13)
VES-13 is performed before the start of the study to evaluate frailty.
Lenalidomide dosage is adjusted according to VES-13 score and renal function.

[VES-13 score<3] (Fit)
<Lenalidomide>
CCr>60ml/min
Lenalidomide 25mg/body once daily
30<CCr<60ml/min
Lenalidomide 15mg/body once daily
CCr<30ml/min
Lenalidomide 15mg/body every other day

<Dexamethasone>
40mg/day weekly

[VES-13 score>=3] (Frail)
<Lenalidomide>
CCr>60ml/min
Lenalidomide 15mg/body once daily
30<CCr<60ml/min
Lenalidomide 10mg/body once daily
CCr<30ml/min
Lenalidomide 5mg/body once daily

<Dexamethasone>
20mg/day weekly
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)aged more than 20 years old
(2)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG)
(3)relapsed or refractory cases after at least one prior chemotherapy
(4)having measurable paraprotein
(5)performance status:0-2,or 3 due to osteolytic lesions alone
(6)coexisting conditions are eligible as follows:
1)neutrophil count; more than 1,000/mm3
2)platelet count; more than 75,000/mm3
3)serum AST, ALT< 5 times the ULN
4)serum T-Bil< 3 times the ULN
5)serum Cr< 3 times the ULN
6)ejection fraction >= 50%
(7)Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method
(8)Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
(9)patients who are observed RevMate
Key exclusion criteria (1) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more.
(2)Patients who have had a complication of active double cancer within the past 5 years.
(3)HBs antigen positive,HCV antibody positive, HIV antibody positive patients
(4) serious mental disorders such as schizophrenia
(5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms
(6) Patients with severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection
(7)Patients with plasma cell leukemia, cardiac amyloidosis and POEMS syndrome
(8)Ptients with thrombosis
(9)Women who are or may be pregnant
(10)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code 2408555
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa
TEL 045-331-1961
Email n-tomo@eurus.dti.ne.jp

Public contact
Name of contact person
1st name Tomonori
Middle name
Last name Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code 2408555
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa
TEL 045-331-1961
Homepage URL
Email n-tomo@eurus.dti.ne.jp

Sponsor
Institute Yokohama Municipal Citizen's Hospital
Institute
Department

Funding Source
Organization None
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 Yokohama Municipal Citizen's Hospital
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan
Tel 0453311961
Email ke06-fukushima@city.yokohama.jp

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
2014 Year 03 Month 20 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 12
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
2014 Year 03 Month 17 Day
Date of IRB
2014 Year 02 Month 16 Day
Anticipated trial start date
2014 Year 03 Month 20 Day
Last follow-up date
2020 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 19 Day
Last modified on
2020 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.