Relapsed/Refractory Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
Detailed description
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. • Ixazomib 4 mg This multi-center trial will be conducted in Japan.
Interventions
DRUGIxazomib
Ixazomib capsules
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients who have been confirmed as administration of the drug.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Adverse Events (AEs) | Up to 24 Week (From start of administration to the end of 6 cycles) | 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. |
| Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | Up to 24 Week (From start of administration to the end of 6 cycles) | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 316 investigative sites in Japan, from 24 May 2017 to 8 March 2022.
Pre-assignment details
Participants with a historical diagnosis of relapsed/refractory multiple myeloma were enrolled. Participants received ixazomib as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Ixazomib 4 mg The usual adult dosage for oral administration was 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 was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care. | 742 |
| Total | 742 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 32 |
Baseline characteristics
| Characteristic | Ixazomib 4 mg | — |
|---|---|---|
| Age, Continuous | 70.6 Years STANDARD_DEVIATION 9.85 | — |
| Body Surface Area | 1.53 Square Meter STANDARD_DEVIATION 0.204 | — |
| Duration of Diagnosis of Relapsed/Refractory Multiple Myeloma | 4.49 Years STANDARD_DEVIATION 3.902 | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 0 | 240 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 1 | 294 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 2 | 112 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 3 | 81 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 4 | 15 Participants | — |
| Healthcare Category Inpatient | 306 Participants | — |
| Healthcare Category Outpatient | 436 Participants | — |
| Height | 156.2 Centimeters (cm) STANDARD_DEVIATION 10.01 | — |
| Hepatic Impairment Had Hepatic Impairment | 46 Participants | — |
| Hepatic Impairment Had No Hepatic Impairment | 696 Participants | — |
| International Staging System Missing | 50 Participants | — |
| International Staging System Stage I | 140 Participants | — |
| International Staging System Stage II | 260 Participants | — |
| International Staging System Stage III | 290 Participants | — |
| Medical Complications Had Medical Complications | 434 Participants | — |
| Medical Complications Had No Medical Complications | 307 Participants | — |
| Medical History Had Medical History | 259 Participants | — |
| Medical History Had No Medical History | 475 Participants | — |
| Medical History Unknown | 7 Participants | — |
| Number of Participants with Relapsed/Refractory Multiple Myeloma | 742 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 742 Participants | — |
| Renal Impairment Had No Renal Impairment | 448 Participants | — |
| Renal Impairment Had Renal Impairment | 294 Participants | — |
| Sex: Female, Male Female | 391 Participants | — |
| Sex: Female, Male Male | 351 Participants | — |
| Weight | 54.10 Kilograms (kg) STANDARD_DEVIATION 11.764 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 742 |
| other Total, other adverse events | 515 / 742 |
| serious Total, serious adverse events | 193 / 742 |
Outcome results
Primary
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)
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixazomib 4 mg | Number of Participants Reporting One or More Adverse Events (AEs) | 642 Participants |
Primary
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)
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixazomib 4 mg | Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) | 573 Participants |