UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma.
Acronym	JSCT-MM10
Scientific Title	Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma.
Scientific Title:Acronym	JSCT-MM10
Region	Japan

Condition
Condition	Multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of Bortezomib and dexamethasone as re-induction therapy in patients with non-response to high dose dexamethasone therapy. To investigate efficacy and safety of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Probability of CR+VGPR after lenalidomide plus dexamethasone consolidation therapy.
Key secondary outcomes	1.Probability of CR+VGPR after lenalidomide maintenance therapy. 2.time to progression (TTP) 3.2-years progression free survival (PFS) 4.2-years overall survival (OS) 5.Incidence of 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	High dose dexamethasone therapy(one course):Dexamethasone 40mg/body po or iv(day 1-4,9-12,17-20) Bortezomib plus dexamethasone therapy(up to 4 courses):Bortezomib 1.3mg/m2 iv (day1,4,8,11).Dexamethasone 20mg/body po (day1,2,4,5,8,9,11,12) PBSC harvest:Cyclophosphamide 2g/m2 div (day1,2) High dose Chemotherapy (L-PAM) and PBSCT:L-PAM 100mg/m2 div (day-3,-2). PBSCT(day0) Lenalidomide plus dexamethasone therapy (2 courses): Lenalidomide 25mg/body po (day1 to 21). Dexamethasone 40mg/body po (day1,8,15,22). Lenalidomide maintenance therapy (one year): Lenalidomide 10mg/body po (day1 to 21)
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG) 2.Measureable M protein in serum or urine. 3.Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.) 4. Age from 20 to 65 years old. 5.Main Organ function is maintained 6. Those who are evaluated to be able to survive more than 3 months. 7.For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study. 8.In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained. Bortezomib plus dexamethasone therapy (at the second registration) 1. The efficacy evaluation after high dose dexamethasone therapy is under VGPR. 2. Good performance status (0-2). 3. Main Organ function is maintained. 4. Those who are evaluated to be able to survive more than 3 months.
Key exclusion criteria	1.Peripheral neuropathy (>=grade 2) 2.Prior high dose dexamethasone therapy caused severe adverse events as follows; Liver dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection. 3.Patient was suspected pneumonia (Interstitial pneumonia) by high dose dexamethasone therapy. (Consult a respiratory specialist if necessary) 4.Those who are considered as inappropriate to register by attending physicians.
Target sample size	37

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazutaka Sunami
Organization	National Hospital Organization Okayama Medical Center
Division name	Division of Hematology
Zip code
Address	Okayama, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	JSCT
Division name	MM10 datacenter
Zip code
Address
TEL
Homepage URL
Email	jsct-office@umin.ac.jp

Sponsor
Institute	Japan Study Group for Cell Therapy and Transplantation
Institute
Department

Funding Source
Organization	Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

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	Main results already published
Date of protocol fixation	2010 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2014 Year 05 Month 20 Day
Date of closure to data entry	2014 Year 05 Month 24 Day
Date trial data considered complete	2015 Year 06 Month 17 Day
Date analysis concluded	2015 Year 08 Month 12 Day

Other
Other related information

Management information
Registered date	2010 Year 10 Month 20 Day
Last modified on	2018 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005281

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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