Trials / Active Not Recruiting
Active Not RecruitingNCT05013190
A Study of NINLARO® in Chinese Adults With Multiple Myeloma
Clinical Outcome of Ixazomib (NINLARO®) Based Regimens in Chinese Patients With Multiple Myeloma Previously Receiving a Bortezomib/Carfilzomib-Based (re)Induction Regimen in Clinical Setting of Real World: An Open-Label, Single-Arm, Multicenter, Observation Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib/carfilzomib -based to an Ixazomib-based treatment.
Detailed description
This is a non-interventional, prospective study of participants with multiple myeloma (MM). Participants will be treated with ixazomib based regimens until progression or unacceptable toxicity leading to a discontinuation or change in regimen, for a maximum of 26 cycles (24 months) (as per NINLARO® label) in real world clinical setting. The study will enroll approximately 80 participants. The data will be collected prospectively in medical charts and will be recorded into electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort: • Participants with MM This multi-center trial will be conducted in China. The overall time for data collection in the study will be 24 months. Participants will be followed once every 3 months for a period not exceeding 24 months, ending 12 months after the last participant's enrollment unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | This is a non-interventional study. |
Timeline
- Start date
- 2021-10-29
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2021-08-19
- Last updated
- 2026-01-08
Locations
12 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05013190. Inclusion in this directory is not an endorsement.