NCT03169361 · REGISTRY CONDITION SEARCH

NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2023-12-07

The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants Reporting One or More Adverse Events (AEs)

→

outcome · POSTED

Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * All patients who have been confirmed as administration of the drug. Exclusion Criteria: * None
healthy Volunteers: false
sampling Method: PROBABILITY_SAMPLE
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT
study Population: The study population will consist of all participants with a diagnosis of multiple myeloma and received their first dose of NINLARO/lenalidomide, and dexamethasone.

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: Ixazomib
label
Ixazomib 4 mg

interventions

arm Group Labels
Ixazomib 4 mg
description
Ixazomib capsules
name
Ixazomib
other Names
NINLARO capsules
MLN9708
type
DRUG

Study design

observational Model: COHORT
time Perspective: PROSPECTIVE

Enrollment

count: 774
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants Reporting One or More Adverse Events (AEs)
time Frame
Up to 24 Week (From start of administration to the end of 6 cycles)
description
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.
measure
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
time Frame
Up to 24 Week (From start of administration to the end of 6 cycles)

Full study description

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.

Source references