UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036375 |
|---|---|
| Receipt number | 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 | 2023/10/04 15:05:25 |
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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 | Akira |
| Middle name | |
| Last name | Tanimura |
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
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
akiratan@jadecom.jp
Sponsor or person
Institute
Tokyo-Kita Medical Center
Institute
Department
Personal name
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
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
| 2024 | Year | 03 | 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
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041398
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