UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019917 |
|---|---|
| Receipt number | R000022473 |
| Scientific Title | Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2019/11/28 15:21:03 |
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Basic information
Public title
Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma
Acronym
Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma (GHSG MM-01)
Scientific Title
Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma
Scientific Title:Acronym
Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma (GHSG MM-01)
Region
| Japan |
Condition
Condition
Unfit patients with relapsed or refractory multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To search therapeutic strategy that obtain maximum effect with minimizing adverse events for elderly or frail patients with relapsed or refractory multiple myeloma,
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The best response during 1 year from initiation of treatment.
Key secondary outcomes
(1) Safety: Hematological toxicity of grade 4, non-hematological toxicity of grade 3 to 4
(2) Continuation rate of treatment
(3) Total dosage of lenalidomide
(4) Overall survival
(5) Progression-free survival (the rate of patients who are not recognized as having progression or recurrence)
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
Lenalidomide 10mg daily on day 1-21 every 28 days, Dexamethasone 20mg a week on day 1, 8, 15, and 22 every 28 days
Lenalidomide dose will be escalated from 10mg to 25mg (5mg per cycle) if there are no grade3 hematological toxicities and grade2 non-hematological toxicities.
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) Multiple myeloma diagnosed in the criteria of IMWG
(2) Patients aged 20 years old and over with autologous stem cell transplantation ineligible multiple myeloma
(3) There is no treatment experience with lenalidomide, relapsed or refractory multiple myeloma patients with medical history over the past 1 regimen (bortezomib intolerance, also including patients paraprotein relapse)
(4) Patients who have been judged by the initial dose of the attending physician is necessary loss of lenalidomide
(5) Patients with ECOG of Perfomance Status (PS) 0-3
(6) Patients who keep the function of major organs, it meets the following criteria
1. Neutrophil count 1,000 / mm3 or more
2. Platelets 50,000 / mm3 or more
3. Serum total bilirubin value is less than three times of the facility upper limit of normal
4. Serum AST, ALT value is less than five times of the facility upper limit of normal
(7) 6 months or more of survival can be expected
(8) Creatinine clearance 30 mL / min or more
(9) Patients who can comply with lenalidomide drug management procedures (RevMate)
(10) In patients receiving notice, that consent in writing was obtained from his participation in the study
Key exclusion criteria
(1) Patients who have received treatment with lenalidomide
(2) Patients who have hypersensitivity to lenalidomide or dexamethasone
(3) non-secretory myeloma, solitary plasmacytoma, plasma cell leukemia, of POEMS syndrome patients
(4) HBs antigen positive, HCV antibody-positive, HTLV-I antibody-positive cases, of HIV antibody-positive patients
(5) Patients with a history of malignancy
(6) Patients with pregnancy, patients who may be pregnant, or patients during lactation
(7) uncontrolled liver dysfunction, renal dysfunction, cardiac dysfunction, lung dysfunction, diabetes, A high blood pressure, infections
(8) patients with severe mental disorders
(9) patients with deep vein thrombosis or pulmonary embolism
(10) Patients who are regarded as inappropriate for participation to this clinical study by attending physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Tsurumi |
Organization
Gifu University Hospital
Division name
Department of hematology
Zip code
501-1194
Address
1-1 Yanagido Gifu
TEL
058-230-6000
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kitagawa |
Organization
Gifu University Hospital
Division name
Department of hematology
Zip code
501-1194
Address
1-1 Yanagido Gifu
TEL
058-230-6000
Homepage URL
http://seesaawiki.jp/ghsg/
jkitagawa1128@gmail.com
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of hematology, Gifu University Hospital
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
IMedical Review Board of Gifu University Graduate School of Medicine
Address
1-1 Yanagido Gifu
Tel
058-230-6059
rinri@gifu-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
岐阜大学医学部附属病院（岐阜県）
岐阜県総合医療センター（岐阜県）
岐阜市民病院（岐阜県）
岐阜赤十字病院（岐阜県）
岐北厚生病院（岐阜県）
一宮市立木曽川市民病院（愛知県）
高山赤十字病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
http://image01.seesaawiki.jp/g/g/ghsg/0dd6c19d776fe02a.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022473
