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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013704
Receipt No. R000015995
Scientific Title Targeting Complete Response in Younger transplant-eligible Multiple myeloma patients with Bortezomib and Lenalidomide treatment after relapse with autologous stem cell transplantation
Date of disclosure of the study information 2014/04/14
Last modified on 2014/04/18

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Basic information
Public title Targeting Complete Response in Younger transplant-eligible Multiple myeloma patients with Bortezomib and Lenalidomide treatment after relapse with autologous stem cell transplantation
Acronym CYMBAL study
Scientific Title Targeting Complete Response in Younger transplant-eligible Multiple myeloma patients with Bortezomib and Lenalidomide treatment after relapse with autologous stem cell transplantation
Scientific Title:Acronym CYMBAL study
Region
Japan

Condition
Condition multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The study will be conducted to evaluate the safety and efficacy of re-treatment for transplant-eligible multiple myeloma patients who relapsed after autologus stem cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of achivement of CR or more after VRD therapy
Key secondary outcomes 1) Distribution of all response after treatment
2) The ratio of patients who complete the treatment protocol
3) 2 year progression free survival
4) 2 year overall suvival
5) safety

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 1) VRD therapy (4X21-day cycles)
Bortezomib
1.3mg/m2 i.v. or s.c. day1,8,15
Lenalidomide
25mg/body p.o. day1-14
Dexamethasone
40mg/body p.o. day1,8,15

2-1) Patients less than 50 years of age who have candidates for allogenic hematopoietic cell transplantation (allo-HCT) donor
2-1-1) Patients who keep autologous stem cell
Autologous peripheral blood stem cell transplantation (auto PBSCT) followed by allo-HCT
2-1-2) Patients who don't keep autologous stem cell
Peripheral blood stem cell harvest mobilised by cyclophosphamide
PBSC+; auto PBSCT followed by allo-HCT
PBSC-; additional 0-4 cycles of VRD therapy follwed by lenalidomide (LEN) maintenance

2-2) Patients who don't fit 2-1) criteria
2-2-1) Patients who keep autologous stem cell
Auto PBSCT followed by LEN maintenance
2-2-2) Patients who don't keep autologous stem cell
Peripheral blood stem cell harvest mobilised by cyclophosphamide
PBSC+; auto PBSCT followed by LEN maintenance
PBSC-; additional 4 cycles of VRD therapy follwed by LEN maintenance



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) Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
2) Patients who achieved at least partial response (PR) after auto PBSCT with or without consolidation therapy
3) 1 year has elapsed since auto PBSCT
4) Patients who meet the following re-treatment criteria
4-1) Patient with secretory myeloma resulted in clincal relapse
4-2) Patients with PR with monoclonal protein (M protein) levels of less or equal 0.5g/dL, resulted in either the clinical or significant paraprotein relapse
4-3) Patients relapsing from complete response (CR) or very good partial response (VGPR), resulted in either the clinical relapse or paraprotein relapse with 0.5g/dL or more M protein.
5) Patients with a measurable lesion or
quantifiable M protein
6) Patients who are 20 to 65 years old at the time of enrollment in this study
7) Patients in good general condition (in ECOG Performance Status;0to2)
8) Pathents who have the following physical function 14 days before enrollment (N presents the upper limit of the institutional standard value)
8-1) SpO 2;94% or more (including indirect SpO2 measurement)
8-2) neutrophil count;1000/uL or more and platelet count;50000/uL or more
8-3) unnecessary for hemodialysis
8-4)Total bilirubin ;less ore equal 1.5XN, AST ;less or equal2.5XN and ALT ;less ore equal 2.5XN
9) 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 or male patients who agree to contraception by contraceptive operation or other appropriative method
10) 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 Imformed Concent Form and Patient Inmormation

Key exclusion criteria 1) Patients with a past history of allergy to the drug described in the protocol
2) Patients daiagnosed plasma cell neoplasm other than symptomatic multiple myeloma
3) Patients who cannnot be expected to live for more than 3 months
4) Patients who have had a complication of active double cancer* within the past 5 years
*Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment, or lesions corresponding to intramucosal carcinoma (cervical carcinoma presenting in FIGO stage I)
5) HBs antigen, HCV antibody or HIV antibody positive patients
6) Patients with grade 2 or severer peripheral neuropathy or peripherl neurogenic pain (CTCAE v4.0)
7) Patients who have or suspected of having a serious active infection
8) Patients with serious mental disorders
9) Patients with serious pulmonary dysfunction
10) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality (e.g. a shadow of ground-glass opacity) on CT scan regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or radiologist)
11) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment
12) Patients who are complicated by poorly controlled diabetes mellitus
13) Patients who are receiving hemodialysis
14) Patients who have serious liver dysfunction
15)Women who are or may be pregnant or are nursing
16) Other patients who are, in the opinion of the caring investigator, unfit for enrolloment in this study
Target sample size 41

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL 048-647-2111
Email ycanda-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiriko Saito
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL 048-647-2111
Homepage URL
Email goodluck@y7.dion.ne.jp

Sponsor
Institute Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization Div. Hematol, Saitama Medical Center, Jichi Medical Univ.
This research fund is in part supported by the donation from Celgene, Kyowa Hakko Kirin, Takeda Pharma, Shionogi Pharma Co., Ltd., etc.
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 14 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
2014 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 14 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
2014 Year 04 Month 13 Day
Last modified on
2014 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015995

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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