UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032675 |
|---|---|
| Receipt number | R000037258 |
| Scientific Title | Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/05/25 17:05:18 |
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Basic information
Public title
Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma.
Acronym
prospective trial of ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma
Scientific Title
Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma.
Scientific Title:Acronym
prospective trial of ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma
Region
| Japan |
Condition
Condition
refractory multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of consolidation and maintenance therapy with IRd therapy in patients with transplant-ineligible multiple myeloma.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of stringent CR achievemnt during the IRd therapy.
Key secondary outcomes
1 Time to sCR achievement period
2 MRD negativity achievement rate
3 ORR
4 Safety
5 PFS
6 OS
7 pharmacokinetics of lenalidomide, ixazomib
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
The patients are treated with ixazomib (Day1, 8, 15) and lenalidomide (Day1-21) and dexamethasone (Day1, 8, 15, 22) therapy every 28 day cycle for 1 year
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 MM patients with PR, VGPR, CR
2 transplant-ineligible MM patients without the improvement of response depth during the most recent 6 cycles of Ld therapy.
3 with consent
4 measureble M-protein
5 PS 0-2
6 contraceptive
Key exclusion criteria
1 relapsed myeloma
2 previous treatment history of ixazomib
3 not tolerable to lenalidomide, bortezomib, dexamethasone
4 with Grade 2 or higher peripheral neuropathy
5 pregnancy
6 Abnormality of blood test
7 CNS involvement
8 Plasma cell leukemia
9 with severe infection
10 with intestinal pneumoniae
11 with double and more cancer
12 without consent of blood transfusion
13 and other
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Kobayashi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Hematology, Nephrology, Rheumatology,
Zip code
Address
1-1-1 Hondo, Akita City, Akita, Japan
TEL
018846116
takahiro@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kobayashi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Hematology, Nephrology, Rheumatology,
Zip code
Address
1-1-1 Hondo, Akita City, Akita, Japan
TEL
018846116
Homepage URL
takahiro@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University hosipital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037258
