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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024166
Receipt No. R000027818
Scientific Title Phase 2 study of clarithromycin, pomalidomide and dexamethasone(ClaPD) for patients with relapsed or refractory multiple myeloma
Date of disclosure of the study information 2016/09/26
Last modified on 2016/09/26

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Basic information
Public title Phase 2 study of clarithromycin, pomalidomide and dexamethasone(ClaPD) for patients with relapsed or refractory multiple myeloma
Acronym ClaPD for RRMM
Scientific Title Phase 2 study of clarithromycin, pomalidomide and dexamethasone(ClaPD) for patients with relapsed or refractory multiple myeloma
Scientific Title:Acronym ClaPD for RRMM
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 ClaPD therapy for relapsed or refractory multiple myeloma patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Progression-free survival,Overall survival,Complete response rate,Stringent complete response rate,Very good partial response rate,Partial response rate,

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 <ClaPD>
Clarithromycin 400mg x 2/day(Day1-28) p.o
Pomalidomide 1-4mg/day(Day1-21) p.o
Dexamethasone 20-40mg/day(Day1, 8, 15, 22) p.o
28day/cycle until PD
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1)aged 20 and more than 20 years old ,and 80 and less than 80 years old
(2)progression disease cases after latest chemotherapy who received bortezomib and lenalidomide before.
(3)having measurable paraprotein; M protein>=0.5g/dL (IgG,IgA,IgM),or M protein>=0.05g/dL (IgD), or Urine M protein>200mg/day
(4)performance status:0-2,or 3 due to osteolytic lesions alone
(5)coexisting conditions are eligible as follows:
・serum AST, ALT< 3 times the ULN
・neutrophil count; more than 1,000/mm3
・platelet count; more than 75,000/mm3
・serum AST, ALT< 5 times the ULN
・percutaneous oxygen saturation>=93%
(6)expected surviving more than 1 month
(7)patients who are observed RevMate
(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
Key exclusion criteria Pregnancy or Lactation
Patients with plasma cell leukemia, cardiac amyloidosis and POEMS syndrome
Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 3 or more
Patients with severe hepatic dysfunction, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, and uncontrolled hypertension
Patients with tuberculosis, herpetic keratoconjunctivitis, systemic fungal infection, and with other active infections
Patients with acute myocardial infarction within 6 months, with deep venous thrombosis or with pulmonary embolism within 3 years
Patients who have had a complication of active double cancer within the past 5 years
HBs antigen positive,HCV antibody positive, HIV antibody positive patients
Patients with a clinical picture of interstitial pneumonia or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms
Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Ando
Organization Tokai University
Division name Division of Hematology/Oncology
Zip code
Address 143 shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Email andok@keyaki.cc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Numata
Organization Tokai University
Division name Division of Hematology/Oncology
Zip code
Address 143 shimokasuya, Isehara, Kanagawa
TEL 0463-93-1121
Homepage URL
Email gensasuke@yahoo.co.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization None
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 東海大学病院(神奈川県)、海老名総合病院(神奈川県)、秦野赤十字病院(神奈川県)、小澤病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 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
Date of protocol fixation
2015 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 26 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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