Unique ID issued by UMIN | UMIN000031216 |
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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 |
A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated with Ixazomib plus Lenalidomide and Dexamethasone
Japan |
Relapsed and/or Refractory Multiple Myeloma
Hematology and clinical oncology |
Malignancy
YES
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.
Safety,Efficacy
Phase IV
Progression-free survival (PFS)
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
300
1st name | |
Middle name | |
Last name | Shinsuke Iida |
Nagoya City University Graduate School
Medical Sciences, Hematology and Oncology
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-shi, Aichi
03-6779-8013
ixa_obs_office@cmic.co.jp
1st name | |
Middle name | |
Last name | Takeda Study Registration Call Center |
Takeda Pharmaceutical Company Limited
Medical Research, Global Medical Affairs-Japan,
1-1, Nihonbashihoncho 2-chome, Chuo-ku, Tokyo
03-3278-2111
ixa_obs_office@cmic.co.jp
Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited
Profit organization
YES
NCT03433001
A service of the U.S. National Institutes of Health
JapicCTI-183860
Japan Pharmaceutical Information Center
2018 | Year | 02 | Month | 09 | Day |
Unpublished
No longer recruiting
2018 | Year | 01 | Month | 29 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 04 | Month | 02 | Day |
2021 | Year | 05 | Month | 31 | Day |
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.
2018 | Year | 02 | Month | 09 | Day |
2019 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035466
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