UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028488 |
|---|---|
| Receipt number | 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 | 2022/10/09 17:16:21 |
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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
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Ishida |
Organization
Japan Red Cross Medical Center
Division name
Hematology
Zip code
150-8935
Address
4-1-22 Hiroo Shibuyaku Tokyo
TEL
03-3400-1311
i.s.h.i.28@rondo.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Handa |
Organization
Gunma University Hospital
Division name
Division of Hematology
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi Gunma
TEL
027-220-8166
Homepage URL
handahiroshi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
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
Gunma University Hospital
Address
3-39-15 Showa-machi Maebashi Gunma
Tel
027-220-8763
nakamurt@gunma-u.ac.jp
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2022 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032596
