A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refrac
The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.
| Condition(s) | Relapsed/Refractory Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma. |
| Who can participate | Inclusion Criteria: * For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date * For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2 * |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Janssen Pharmaceutica N.V., Belgium |
| Locations | Leoben, Austria; Vienna, Austria; Edegem, Belgium; Genk, Belgium; Leuven, Belgium; Mons, Belgium (+83 more sites) |
| Start date | 2021-11-18 |
| NCT ID | NCT05160584 |
| Official listing | https://clinicaltrials.gov/study/NCT05160584 |