UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004421
Receipt No. R000005281
Scientific Title Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma.
Date of disclosure of the study information 2010/10/20
Last modified on 2018/08/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.