UMIN-CTR Clinical Trial

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
Email	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/
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	IMedical Review Board of Gifu University Graduate School of Medicine
Address	1-1 Yanagido Gifu
Tel	058-230-6059
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022473