UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031216 |
|---|---|
| Receipt number | R000035466 |
| Scientific Title | A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2019/07/01 15:09:18 |
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Basic information
Public title
A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
Acronym
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
Scientific Title
A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
Scientific Title:Acronym
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
Region
| Japan |
Condition
Condition
Relapsed and/or Refractory Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Progression-free survival (PFS)
Key secondary outcomes
PFS rate at 12 months and 24 months
Overall survival (OS)
Best response
Time to next treatment (TTNT)
Duration of therapy (DOT)
Proportion of patients who continue to receive treatment at 12 months and 24 months after start of treatment
Overall response rate (ORR)
Complete response (CR) plus very good partial response (VGPR) rate (CR+VGPR rate)
Patient-reported outcomes: health-related quality of life (HRQoL), as evaluated by the EORTC QLQ-C30 and MY-20 instruments
Rate of minimal residual disease (MRD) negativity in the bone marrow of patients who achieve CR
Relative dose intensity (RDI) for ixazomib, lenalidomide and dexamethasone
Bone evaluation
AEs
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Men and women aged 20 years or older at the time of enrollment
2. Patients with RRMM
3. Patients who are scheduled to start IRd therapy
4. Patients who can provide written informed consent of their own free will before the start of study treatment
5. Patients who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study
Key exclusion criteria
1. Female patients who are nursing or pregnant
2. Patients who have been treated with ixazomib
3. Patients with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
4. Patients with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for patients with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment
5. Patients who are not registered with, or comply with, the guidelines of the lenalidomide management program
6. Patients who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Iida |
Organization
Nagoya City University Graduate School
Division name
Medical Sciences, Hematology and Oncology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-shi, Aichi
TEL
03-6779-8013
ixa_obs_office@cmic.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeda Study Registration Call Center |
Organization
Takeda Pharmaceutical Company Limited
Division name
Medical Research, Global Medical Affairs-Japan,
Zip code
Address
1-1, Nihonbashihoncho 2-chome, Chuo-ku, Tokyo
TEL
03-3278-2111
Homepage URL
ixa_obs_office@cmic.co.jp
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT03433001
Org. issuing International ID_1
A service of the U.S. National Institutes of Health
Study ID_2
JapicCTI-183860
Org. issuing International ID_2
Japan Pharmaceutical Information Center
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 09 | 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 | 01 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | 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
To investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035466
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