Clinical trial · Observational
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
NCT03433001CI-TRIAL-00072037completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed and/or Refractory Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ixazomib | Drug | Ixazomib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Ixazomib + Lenalidomide + Dexamethasone
- description
- Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
- interventionNames
- Drug: Ixazomib
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 36 Months as a maximum
- description
- PFS was defined as the period from the start of ixazomib, lenalidomide, dexamethasone (IRd) therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved free light chain (FLC) levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women aged 20 years or older at the time of enrollment 2. Patients with RRMM 3. Participants who are scheduled to start IRd therapy 4. Participants who can provide written informed consent of their own free will before the start of study treatment 5. Participants who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study Exclusion Criteria: 1. Female Participants who are nursing or pregnant 2. Participants who have been treated with ixazomib 3. Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients 4. Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment 5. Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program 6. Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
References
Publications (2)
- DERIVEDKogure Y, Handa H, Ito Y, Ri M, Horigome Y, Iino M, Harazaki Y, Kobayashi T, Abe M, Ishida T, Ito S, Iwasaki H, Kuroda J, Shibayama H, Sunami K, Takamatsu H, Tamura H, Hayashi T, Akagi K, Shinozaki T, Yoshida T, Mori I, Iida S, Maeda T, Kataoka K. ctDNA improves prognostic prediction for patients with relapsed/refractory MM receiving ixazomib, lenalidomide, and dexamethasone. Blood. 2024 Jun 6;143(23):2401-2413. doi: 10.1182/blood.2023022540. PMID 38427753
- DERIVEDHorigome Y, Iino M, Harazaki Y, Kobayashi T, Handa H, Hiramatsu Y, Kuroi T, Tanimoto K, Matsue K, Abe M, Ishida T, Ito S, Iwasaki H, Kuroda J, Shibayama H, Sunami K, Takamatsu H, Tamura H, Hayashi T, Akagi K, Maeda T, Yoshida T, Mori I, Shinozaki T, Iida S. A prospective, multicenter, observational study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in Japan. Ann Hematol. 2024 Feb;103(2):475-488. doi: 10.1007/s00277-023-05428-7. Epub 2023 Sep 11. PMID 37695378