UMIN-CTR Clinical Trial

Basic information
Public title	the study of the influence of the harvest of the CD34 positive peripheral blood stem cell of the induction therapy using lenalidomide,cyclophosphamide,dexamethasone(RCd therapy) for untreated symptomatic multiple myeloma
Acronym	the study of the influence of the harvest of peripheral blood stem cell using RCd therapy for multiple myeloma
Scientific Title	the study of the influence of the harvest of the CD34 positive peripheral blood stem cell of the induction therapy using lenalidomide,cyclophosphamide,dexamethasone(RCd therapy) for untreated symptomatic multiple myeloma
Scientific Title:Acronym	the study of the influence of the harvest of peripheral blood stem cell using RCd therapy for 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 examine the efficacy and safety of the induction regimen,that is high dose dexamethasone therapy and then the combination therapy of lenalidomide,cyclophosphamide and dexamethasone(RCd therapy) prior to autologous stem cell transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	the amount of autologus blood stem cell harvest
Key secondary outcomes	response rale

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	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	1) high dose dexamethasone therapy 1 cycle is 28 days (day1-4,7-10,17-20) 1 cycle is administered 2)RCd therapy Combination therapy of lenalidomide,cyclophosphamide and dexamethasone each cycle is 28 days. RCd therapy is repeated 4 cycles 3)auto peripheral blood stem cell harvest by the conditioning regimen of high dose cyclophosphamide. 4) peripheral blood stem cell autotransplation by the conditioning regimen of high dose L-PAM.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)symptomatic untreated multiple myeloma diagnosed by criteria of IMWG 2)Aged 20 to 65 years old 3)Performance Status(PS) of 0-2 on ECOG scale 4)The function of the organ is kept,and the following standards are filled 4-1 bone marrow function 4-1-1 the neutrophil counts is 1,000/micro liter or more 4-1-2 the platelet is 5,0000/micro liter or more 4-1-3 Hb is 8.0 g/dl or more 4-2 liver function 4-2-1 The serum AST,ALT value is less than twice a facilities standard value. 4-2-2 The serum total bilirubin value is 2.0 mg/dl or less 4-3 renal function 4-3-1 The serum creatinine value is 2.0 mg/dl or less 4-4 cardiac function 4-4-1 QTc prolongation,ischemic change,atrial fibrillation and ventricular arrhythmia to need treatment is neither found in echocardiography. 4-4-2 LV Ejection Fraction is 50 percent or more. 4-5 respiratory function 4-5-1 Abnormal findings in lung field are not recognized on X-ray
Key exclusion criteria	1)myeloma of nonsecreted form, plasma cell leukemia 2)patients of HIV antibody positivity, HCV antibody positivity and HBs antigen positivity 3)patients who are defective to control liver , renal ,cardiac or respiratory function and patients who suffer from diabetes, high blood pressure and infectious disease. 4) patients who suffer from brisk double cancer 5)patients of serious mental disorder 6)pregnant women and possibility getting pregnant,and suckling during examination period 7)patients who admit lung injury according to clinical findings. And patients who recognize abnormal shadow in the lung field on the Xp or CT. 8)Additionally, patients whom doctor in charge judges inappropriate
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Arima Naomichi
Organization	Kagoshima University Hospital
Division name	Dept Hematology and Immunology
Zip code
Address	Sakuragaoka 8-35-1,Kagoshima City
TEL	099-275-5934
Email

Public contact
Name of contact person	1st name Middle name Last name Kawada Hideaki
Organization	Kagoshima University Hospital
Division name	Dept Hematology and Immunology
Zip code
Address	Sakuragaoka 8-35-1,Kagoshima City
TEL	099-275-5934
Homepage URL
Email	hkawada@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital, Dept. Hematology and Immunology
Institute
Department

Funding Source
Organization	Kagoshima University Hospital,Dept. Hematology and Immunology
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
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	鹿児島大学病院（鹿児島県）、鹿児島医療センター（鹿児島県）、慈愛会　今村病院（鹿児島県）、慈愛会　今村病院分院（鹿児島県）、　今給黎病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 07 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	Open public recruiting
Date of protocol fixation	2012 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2015 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	2012 Year 09 Month 06 Day
Last modified on	2013 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010197

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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