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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019917
Receipt No. 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 2018/12/03

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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
Last name of lead principal investigator
1st name
Middle name
Last name Hisashi Tsurumi
Organization Gifu University Hospital
Division name Department of hematology
Zip code
Address 1-1 Yanagido Gifu
TEL 058-230-6000
Email htsuru@gifu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Junichi Kitagawa
Organization Gifu University Hospital
Division name Department of hematology
Zip code
Address 1-1 Yanagido Gifu
TEL 058-230-6000
Homepage URL http://seesaawiki.jp/ghsg/
Email jkitagawa1128@gmail.com

Sponsor
Institute Gifu University Hospital
Institute
Department

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
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 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
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
Anticipated trial start date
2014 Year 03 Month 01 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
2015 Year 11 Month 24 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022473

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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