UMIN-CTR Clinical Trial

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	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 26 Day
Date of IRB	2017 Year 05 Month 30 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2025 Year 05 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	2017 Year 03 Month 10 Day
Last modified on	2021 Year 03 Month 13 Day

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