主要目標: 評估 isatuximab 用於常規臨床實踐中 RRMM 患者 12 個月內的療效,以整體緩解率(ORR)表示 評估 isatuximab 的其他療效參數,如無惡化存活期(PFS)、PFS 率(PFSR)、緩解持續時間(DoR)、至緩解時間、至首次後續治療的時間及意圖、非常好的部分緩解或更佳率、完全緩解(CR)或更佳率
適應症:Plasma Cell Myeloma
收案條件
納入條件
- Age ≥18 years or country's legal age of majority if the legal age is \>18 years old at the time of enrollment
- Patients with RRMM who have at least one prior line of therapy
- Patients for whom the treating physician has made the decision to initiate isatuximab per routine practice and independently of the purpose of the study; for retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of three months prior to study enrollment
- Able to understand and complete the study-related questionnaires
- Patient must have given signed informed consent prior to study start. For retrospectively enrolled patients who are deceased at the date of enrollment into the study, a waiver of consent will be required; patients who have started and stopped treatment or whose treatment is still ongoing at ICF are eligible
排除條件
- Patients who are receiving isatuximab for an indication other than RRMM
- Patients who have received any other investigational drug or prohibited therapy for this study within 28 days or five half-lives from randomization, whichever is longer
- Patients having contraindication to the isatuximab summary of product characteristics (SMPC) or package insert (PI)
- Patients having contraindications as noted in the drug-specific local isatuximab SMPC/PI of combination drugs
- Any country-related specific regulation that would prevent the patient from entering the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Further eligibility criteria might apply.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。