UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of clarithromycin, pomalidomide and dexamethasone(ClaPD) for patients with relapsed or refractory multiple myeloma
Title of the study (Brief title)	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	Kiyoshi Ando
Organization	Tokai University
Division name	Division of Hematology/Oncology
Address	143 shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Email	andok@keyaki.cc.u-tokai.ac.jp

Public contact
Name of contact person	Hiroki Numata
Organization	Tokai University
Division name	Division of Hematology/Oncology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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