UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039016 |
|---|---|
| Receipt number | R000044367 |
| Scientific Title | IRD (ixazomib, lenalidomide, and dexamethasone) consolidation therapy after autologous peripheral hematopoietic stem cell transplantation for elderly multiple myeloma patients. |
| Date of disclosure of the study information | 2019/12/28 |
| Last modified on | 2023/10/04 15:08:59 |
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Basic information
Public title
IRD (ixazomib, lenalidomide, and dexamethasone) consolidation therapy after autologous peripheral hematopoietic stem cell transplantation for elderly multiple myeloma patients.
Acronym
IRD consolidation after ASCT
Scientific Title
IRD (ixazomib, lenalidomide, and dexamethasone) consolidation therapy after autologous peripheral hematopoietic stem cell transplantation for elderly multiple myeloma patients.
Scientific Title:Acronym
IRD consolidation after ASCT
Region
| Japan |
Condition
Condition
multiple myaloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety of IRD consolidation therapy after ASCT for MM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of 4 cycles of IRD consolidation therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4 cycles of IRD consolidation therapy will be administered.
ixazomib 3mg at day 1,8, 15 on a 28-day cycle basis.
lenalidomide 15mg at day 1-21 on a 28-day cycle basis.
dexamathasone 20mg day 1, 8, 15, 22 on a 28 day cycle basis.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Participants must sign the most current institutional review board (IRB)-approved informed consent form(ICF).
2) Multiple myeloma patients who received ASCT in 3 months and achieved partial response or better.
3) Age 65 - 74 years or <65 years who are not deemed appropriate for KRD consolidation therapy.
4) ECOG performance status 0-1.
5) Neutrophil >1000 and platelet >75000.
6) Serum GOT or GPT < 3.0 X upper limit of normal (ULN), and Serum total bilirubin < 1.5 ULN
7) Serum creatinine clearance > 30 ml/min.
Key exclusion criteria
1) Peripheral neuropathy grade > 2
2) Uncontrolled diabetes.
3) Uncontrolled hypertension, arrhythmia, or heart failure.
4) Uncontrolled infectious diseases.
5) Uncontrolled psychiatric disorders.
6) Pregnant or lactating patients.
7) Allergic to ixazomib or lenalidomide.
8) Inability to comply with RevMmate.
9) Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Target sample size
28
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
4-17-56 Akabanedai, Kita-ku, Tokyo
TEL
03-5963-3311
akiratan@jadecom.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
4-17-56 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
not applicable
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
4-17-56 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 | 12 | Month | 28 | 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
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | 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 | 12 | Month | 27 | 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=R000044367
