An observational study in Relapsed/Refractory Multiple Myeloma, sponsored by Takeda. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Takeda · Observational
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
The study will enroll approximately 480 patients.
This multi-center trial will be conducted in Japan.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 774 is above the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of all participants with a diagnosis of multiple myeloma and received their first dose of NINLARO/lenalidomide, and dexamethasone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The usual adult dosage for oral administration is 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle will be repeated for 6 cycles. The dose may be reduced appropriately according to the patient's condition. Participants will receive interventions as part of routine medical care.
Drug: Ixazomib
Ixazomib capsules
Also known as: NINLARO capsules, MLN9708
Number of Participants Reporting One or More Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 24 Week (From start of administration to the end of 6 cycles)
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug.
Time frame: Up to 24 Week (From start of administration to the end of 6 cycles)
Participants took part in the survey at 316 investigative sites in Japan, from 24 May 2017 to 8 March 2022.
| Milestone | Ixazomib 4 mg |
|---|---|
| Started | 774 |
| Completed | 742 |
| Not completed | 32 |
| Withdrew: Protocol violation | 32 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| Participants | Ixazomib 4 mg |
|---|---|
| Number of Participants Reporting One or More Adverse Events (AEs) | 642 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug.
| Participants | Ixazomib 4 mg |
|---|---|
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | 573 |
Collected over Up to 24 Week (From start of administration to the end of 6 cycles). Non-serious events are listed at a 5.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ixazomib 4 mg | 11/742 (1.5%) | 193/742 (26%) | 515/742 (69.4%) |
| Event | Ixazomib 4 mg |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 73/742 |
| DiarrhoeaGastrointestinal disorders | 44/742 |
| PneumoniaInfections and infestations | 22/742 |
| VomitingGastrointestinal disorders | 17/742 |
| Neutrophil count decreasedInvestigations | 14/742 |
| NauseaGastrointestinal disorders | 11/742 |
| White blood cell count decreasedInvestigations | 9/742 |
| AnaemiaBlood and lymphatic system disorders | 7/742 |
| Decreased appetiteMetabolism and nutrition disorders | 7/742 |
| Neuropathy peripheralNervous system disorders | 7/742 |
| Event | Ixazomib 4 mg |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 313/742 |
| DiarrhoeaGastrointestinal disorders | 178/742 |
| NauseaGastrointestinal disorders | 82/742 |
| VomitingGastrointestinal disorders | 52/742 |
| RashSkin and subcutaneous tissue disorders | 52/742 |
| Neuropathy peripheralNervous system disorders | 45/742 |
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Age, Continuous(Years) | Ixazomib 4 mg |
|---|---|
| Mean | 70.6 ± 9.85 |
| Sex: Female, Male(Participants) | Ixazomib 4 mg |
|---|---|
| Female | 391 |
| Male | 351 |
| Race and Ethnicity Not Collected(Participants) | Ixazomib 4 mg |
|---|
| Region of Enrollment(Participants) | Ixazomib 4 mg |
|---|---|
| Japan | 742 |
| Duration of Diagnosis of Relapsed/Refractory Multiple Myeloma(Years) | Ixazomib 4 mg |
|---|---|
| Mean | 4.49 ± 3.902 |
| Number of Participants with Relapsed/Refractory Multiple Myeloma(Participants) | Ixazomib 4 mg |
|---|---|
| Count of participants | 742 |
| International Staging System(Participants) | Ixazomib 4 mg |
|---|---|
| Stage I | 140 |
| Stage II | 260 |
| Stage III | 290 |
| Missing | 50 |
| Eastern Cooperative Oncology Group Performance Status(Participants) | Ixazomib 4 mg |
|---|---|
| Scale = 0 | 240 |
| Scale = 1 | 294 |
| Scale = 2 | 112 |
| Scale = 3 | 81 |
| Scale = 4 | 15 |
8 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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