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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036375
Receipt No. R000041398
Scientific Title Efficacy and safety of VRd (bortezomib, lenalidomide, dexamethasone) induction therapy, autologous hematopoietic stem cell transplantation, KRd (carfilzomib, lenalidomide, dexamethasone) consolidation and lenalidomide maintenance therapy for newly diagnosed multiple myeloma (phase II study)
Date of disclosure of the study information 2019/04/01
Last modified on 2021/07/14

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Basic information
Public title Efficacy and safety of VRd (bortezomib, lenalidomide, dexamethasone) induction therapy, autologous hematopoietic stem cell transplantation, KRd (carfilzomib, lenalidomide, dexamethasone) consolidation and lenalidomide maintenance therapy for newly-diagnosed multiple myeloma (phase II study).
Acronym VRd/ASCT/KRd/Len maintenance (TKMC MM1801)
Scientific Title Efficacy and safety of VRd (bortezomib, lenalidomide, dexamethasone) induction therapy, autologous hematopoietic stem cell transplantation, KRd (carfilzomib, lenalidomide, dexamethasone) consolidation and lenalidomide maintenance therapy for newly diagnosed multiple myeloma (phase II study)
Scientific Title:Acronym VRd/ASCT/KRd/Len maintenance (TKMC MM1801)
Region
Japan

Condition
Condition Newly-diagnosed multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy the series of treatments of consised of VRd induction therapy, autologous hematopoietic stem cell transplantation, KRd consolidation and lenalidomide maintenance therapy for newly-diagnosed multiple myeloma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete response rate after KRd consolidation therapy
Key secondary outcomes 1.Overall survival rate
2.Progression-free survival rate
3.Response rates after each regimes
4.Best response rate
5.Number of CD34 positive cell yield by PBSCH
6.Adverse events of each regimens

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) VRd (bortezomib 1.3mg/m^2 day1,4,8,11, lenalidomide 25 mg day1-14, dexamethasone 20mg day1,2,4,5,8,9,11,12, 21-days cycle, 4 cycles)
2) PBSCH by 4g/m^2-cyclophosphamide combined with G-SCF of G-CSF alone
3) ASCT (melphalan 200mg/m^2 supported by autologous hematopoietci stem cells infusion)
4) KRd (carfilzomib 20/27mg day1,2,8,9,15,16, lenalidomide 15mg day1-21, dexamethasone 20mg day1,2,8,9,15,16,22,23, 28-days cycle, 4 cycles)
5) lenalidomide (10mg) maintenace therapy (until PD or intolerance)
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) Newly-diagnosed multiple myeloma (2014 IMWG criteria)
2) ECOG performance status 0-2
3) Reserved organ functions
a) T.Bil </= 1.5 X WNL, and AST/ALT </= 2.5 X WNL
b) ejection fraction >/= 50%
c) SaO2 >/= 93%
4) Written informed consent
Key exclusion criteria 1) Patients who are allergic to drugs used by this protocol study
2) Patients with severe cardiac dysfunction
3) Patients with active and uncontrolled infections
4) Patients with HBs antigen (+) or HCV antibody (+).
5) Patients with uncontrolled malignancies
6) Pregnant women, women who could be pregnant or women who is breast feeding
7) Patients with uncontrolled gastric ulcer
8) Past history of renal transplantation
9) Past history of pulmonary embolism, cardiac infarction and/or brain infarction
10) Patients with uncontrolled diabetes
11) severe psychiatric disorders
12) Patients with other inadequate conditions determined by investigators
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Akiyoshi
Middle name
Last name Miwa
Organization Tokyo-Kita Medical Center
Division name Department of Hematology
Zip code 115-0053
Address 56-17-4 Akabanedai, Kita-Ku, Tokyo
TEL 03-5963-3311
Email miwaamoromniavincit@yahoo.co.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Tanimura
Organization Tokyo-Kita Medical Center
Division name Department of Hematology
Zip code 115-0053
Address 56-4-17, Akabanedai, Kita-Ku, Tokyo
TEL 03-5963-3311
Homepage URL
Email akiratan@jadecom.jp

Sponsor
Institute Tokyo-Kita Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo-Kita Medical Center
Address 56-4-17 Akabanedai, Kita-ku, Tokyo
Tel 03-5963-3311
Email tk-umin@tokyokita-jadecom.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
2019 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2021 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
2019 Year 04 Month 01 Day
Last modified on
2021 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041398

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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