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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026498
Receipt No. R000030430
Scientific Title Evaluation of efficacy and safety of a response adapted therapy adding bortezomib in newly diagnosed, transplant ineligible multiple myeloma patients with insufficient efficacy by lenalidomide - dexamethasone (Rd) therapy.
Date of disclosure of the study information 2017/03/10
Last modified on 2019/09/11

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Basic information
Public title Evaluation of efficacy and safety of a response adapted therapy adding bortezomib in newly diagnosed, transplant ineligible multiple myeloma patients with insufficient efficacy by lenalidomide - dexamethasone (Rd) therapy.
Acronym W-JHS MM01
Scientific Title Evaluation of efficacy and safety of a response adapted therapy adding bortezomib in newly diagnosed, transplant ineligible multiple myeloma patients with insufficient efficacy by lenalidomide - dexamethasone (Rd) therapy.
Scientific Title:Acronym W-JHS MM01
Region
Japan

Condition
Condition Multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We perform an exploratory study on efficacy and safety of the response adapted therapy whose treatment is started with lenalidomide - dexamethasone (Rd) combination therapy and bortezomib is added if the efficacy is insufficient in newly diagnosed, transplant ineligible multiple myeloma patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete response (CR) rate up to 18 cycles
Key secondary outcomes 1. CR rate in the patients with additional administration of bortezomib.
2. Response rate up to 18 cycles.
3. Incidence of adverse events up to 18 cycles.
4. Progression free survival (PFS)
5. Overall survival (OS)
6. Progression free survival from enrollment to progression or death after second line regimen (judged by investigator)(PFS2)
7. Best response in second line regimen.
8. Evaluation of immune dynamics (degree of immune activation)
9. Evaluation of QOL.

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 1.Rd therapy (1-10 cycle):
Lenalidomide from day 1 to day 21 and dexamethasone at day 1, 8, 15 and 22 are administered (10 cycles, every 28 days)
2.Rd+Bor therapy (8 cycles):
Bortezomib is additionally sc administered on day1, 8, 15.
3.Lenalidomide maintenance therapy (every 28 day until PD): Lenalidomide 10mg/day, po (day 1 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

Not applicable
Gender Male and Female
Key inclusion criteria Primary enrollment inclusion criteria
1) Patients are >= 20 years of age
2) Patients who understand the informed consent and can sign the informed consent form by his/her free will.
3) Patients who obey the protocol visit and other rules.
4) Newly diagnosed multiple myeloma.
5) Patients with following measurable M protein by protein electrophoresis analysis
6) Patients who cannot carry out hematopoietic stem cells transplantation.
7) ECOG PS 0, 1 or 2
8) Female childbearing patients who meet the following requirements
Patients who can agree to receive two times of pregnancy test before study drug administration
Patients who can agree to refrain completely from the sex with her partner or be effective contraception measures 28 days before study drug administration, during treatment period and 28 days after discontinuation of study drug administration.
9) Male patients who meet the following requirements:
Patients who can agree to completely refrains from the sex with his partner. 28days after discontinuation of study drug administration.
Patients who agree to not provide a seminal fluid and a sperm during treatment period and 28 days after the discontinuation of study drug administration.
10) Patients who meet the following requirements:
Understand the risk of teratogenicity of lenalidomide.
Can agree to not donate blood during the study drug administration and 28 days after study drug administration.

Secondary enrollment inclusion criteria
1) MM patients meeting all of the following three definitions.
Monoclonal bone marrow plasma cells >=10% or biopsy-proven plasmacytoma
Monoclonal protein (M protein) in serum or urine
any one or more of the following (1) and (2):
(1) Myeloma-related evidence of end organ damage
Hypercalcemia,Renal insufficiency,Anemia,Osteolytic lesion or osteoporosis
(2) Any one or more of the following definition.
60% or greater monoclonal plasma cells on bone marrow examination
Serum Free Light Chain >= 100
More than 2 focal lesions on MR
Key exclusion criteria Primary enrollment exclusion criteria
1) Patients with severe disorder, laboratory test abnormality, mental disease.
2) Patient having a severe disease thought to be exposed to unacceptable risks if he/she participates in the study.
3) Patients who are in a state with the possibility to have an influence on the interpretation of the study data.
4) Patients with treatment history of myeloma.
5) Female patients with pregnancy or nursing.
6) Patients with following laboratory test abnormality.
Neutrophil < 1000/mm3
Platelet before transfusion < 50,000/mm3 (7 days passed after platelet transfusion)
AST or ALT > 3 X ULN
7) Patients with renal failure needed for hemodialysis or peritoneal dialysis.
8) Patients with anamnesis of malignant tumor other than MM
9) Patients who are or will not received antithrombotic therapy.
10) Patients with grade 2 or more peripheral neuropathy.
11) Patients with incontrollable systemic fungal/bacterial/viral infection
12) Patients with primary amyloidosis (AL) (immunoglobulin light chain) or myeloma with amyloidosis.
13) Patients not receiving dexamethasone or with contraindication of dexamethasone. 14) Patients not receiving bortezomib or with contraindication of bortezomib.

Secondary enrollment exclusion criteria
1) Patients met exclusion criteria after primary enrollment.
2) Patient who are confirmed for human immunodeficiency virus (HIV)-positive or treated.
3) Patients with hepatitis B virus (HBs antigen) positive or hepatitis C virus (HCV) antibody positive (if HBc antibody or HBs antibody is positive even if HBs antigen is negative, hepatitis B virus (HBV) DNA test is carried out. If HBV DNA is detected, The patients are excluded)
4) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Yuzuru
Middle name
Last name Kanakura
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code 565-0871
Address C9, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3871
Email kanakura@bldon.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Hirohiko
Middle name
Last name Shibayama
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code 565-0871
Address C9, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3871
Homepage URL
Email hiro@bldon.med.osaka-u.ac.jp

Sponsor
Institute Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Celgene Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Network Fukuoka Certified Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel 092-643-7171
Email mail@crnfukuoka.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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 Day

Related information
URL releasing protocol
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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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
2017 Year 03 Month 10 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030430

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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