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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028488
Receipt No. R000032596
Scientific Title The single-arm phase II study evaluating pomalidomide-plus-dexamethasone for relapsed/refractory multiple myeloma and phase II study evaluating pomalidomide-bortezomib-dexamethasone for the patients who are not able to achieve PR after pomalidomide-plus-dexamethasone therapy
Date of disclosure of the study information 2017/08/02
Last modified on 2018/01/15

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Basic information
Public title The single-arm phase II study evaluating pomalidomide-plus-dexamethasone for relapsed/refractory multiple myeloma and phase II study evaluating pomalidomide-bortezomib-dexamethasone for the patients who are not able to achieve PR after pomalidomide-plus-dexamethasone therapy
Acronym J-MEN 010 Study
Scientific Title The single-arm phase II study evaluating pomalidomide-plus-dexamethasone for relapsed/refractory multiple myeloma and phase II study evaluating pomalidomide-bortezomib-dexamethasone for the patients who are not able to achieve PR after pomalidomide-plus-dexamethasone therapy
Scientific Title:Acronym J-MEN 010 Study
Region
Japan

Condition
Condition Relapse and Refractory Multiple Myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary objective of this study is to evaluate the effect of pomalidomide+dexamethasone therapy for early relapsed multiple myeloma patients who have been previously treated with bortezomib and lenalidomide and within 1-4 prior regimens. The secondary objective is to evaluate pomalidomide+bortezomib+dexamethasone therapy for the patients who are not able to achieve PR after pomalidomide+dexamethasone therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate of 4 cycles of pomalidomid+dexamethasone therapy
Key secondary outcomes Overall response rate of bortezomib+pomalidomid+dexamethasone (BPd)
stringent complete response (sCR)
Complete response (CR)
Overall response (more than PR)
2 years progression free survival
3 years progression free survival
2 years overall survival
3 years overall survival
median progression free survival
adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pomalidomide, Dexamethasone PomD
Pomalidomide, Bortezomib, Dexamethasone PBd
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. Relapsed/refractory multiple myeloma diagnosed according to IMWG criteria and previously treated with bortezomib and lenalidomide.
2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
a.Serum M-protein > 0.5g/dL, or
b.In subjects without detectable serum M-protein, Urine M-protein>200mg/24 hour, or serum free light chai (sFLC)>100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
3. Can receive up to 4 lines of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment)
4. 20 years old or more
5. ECOG Performance status 0 or 1 or 2
6. Patients must meet the following clinical laboratory criteria with 21 days of starting treatment
a. Absolute neutrophil count (ANC) >1,000/mm3 and platelet >50,000/mm3 (>30,000/mm3 if myeloma involvement in the bone marrow is >50%)
b. Total bilirubin<1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3 x ULN.
c. Calculated creatinine clearance > 30mL/min or creatinine < 3mg/dL.
7. adhere to RevMate
8. written informed consent



Key exclusion criteria 1.Female patients who are lactating or pregnant
2.Multiple Myeloma of IgM subtype
3.Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
4.POEMS syndrome
5.Plasma cell leukemia or circulating plasma cells >2 x 109/L
6.Waldenstroms Macroglobulinaemia
7.Patients with known amyloidosis
8.Patients with GVHD
9.Patients with cataract
10.Glucocorticoid>30mg/day 14 days prior to obtaining informed consent
11,Chemotherapy with approved within 21 days prior to starting pomalidomide treatment
12.Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
13.Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
14.Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
15.HBs antigen positive, HCV antibody positive, HIV antibody positive
16.malignancy within the past 3 years except:
a.Adequately treated basal cell or squamous cell skin cancer
b.Carcinoma in situ of the cervix
c.Breast carcinoma in situ with full surgical resection
17.Patients with steroid or lenalidomide hypersensitivity
18.Prior treatment with pomalidomide
19.Peripheral neuropathy > Grade 2
20.Un-controlled liver dysfunction, renal dysfunction, heart failure, lung dysfunction, diabetes, hypertension
21.active infection
22.Myocardial infarction within 4 months or deep vein thrombosis, pulmonary embolism within 3 years prior to informed consent
23.interstitial pneumonitis, pulmonary fibrosis, abnormal interstitial shadow by CT scan
24.inappropriate for study by any reason

Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Sadao Ishida
Organization Japan Red Cross Medical Center
Division name Hematology
Zip code
Address 4-1-22 Hiroo Shibuyaku Tokyo
TEL 03-3400-1311
Email i.s.h.i.28@rondo.ocn.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroshi Handa
Organization Gunma University Hospital
Division name Division of Hematology
Zip code
Address 3-39-15 Showa-machi Maebashi Gunma
TEL 027-220-8166
Homepage URL
Email handahiroshi@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Celgene Corporation
Organization
Division
Category of Funding Organization Profit organization
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 群馬大学医学部附属病院(群馬県)
日本赤十字医療センター(東京都)
公益財団法人仁泉会 北福島医療センター(福島県)
国立病院機構 岡山医療センター(岡山県)
徳島県立中央病院(徳島県)
国立病院機構 災害医療センター(東京都)
札幌医科大学附属病院(北海道)
市立札幌病院(北海道)
神奈川県立がんセンター(神奈川県)
大垣市民病院(岐阜県)
金沢大学付属病院(石川県)
JCHO 京都鞍馬口医療センター(京都府)
静岡県立静岡がんセンター(静岡県)
秋田大学医学部附属病院(秋田県)
社会療法人北楡会 札幌北楡病院(北海道)
医療法人菊郷会 愛育病院(東京都)
公益財団法人 永寿総合病院(東京都)
日本医科大学付属病院(東京都)
近畿大学医学部奈良病院(奈良県)
国立病院機構 渋川医療センター(群馬県)

Japan Myeloma Network

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 02 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
2017 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 08 Month 02 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032596

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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