About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
Disqualifiers
None
Trial population
The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionThere is no interventional treatment component for participants with RRMM in this study.
Treatment groups
Trial outcomes
Primary outcomes
Overall Response Rate (ORR)
Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).
Secondary outcomes
Very Good Partial Response (VGPR) Rate
VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.
Complete Response (CR) Rate
CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.
Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.
Minimal Residual Disease (MRD) Negative Rate
MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.
Sponsors and contacts
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