UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000015621