已完成 NCT04458831

Isatuximab 用于复发及/或难治性多发性骨髓瘤(RRMM)患者的前瞻性、非介入性、跨国、观察性研究

骨髓瘤不适用

主要目标: 评估 isatuximab 用于常规临床实践中 RRMM 患者 12 个月内的疗效,以整体缓解率(ORR)表示 评估 isatuximab 的其他疗效参数,如无进展生存期(PFS)、PFS 率(PFSR)、缓解持续时间(DoR)、至缓解时间、至首次后续治疗的时间及意图、非常好的部分缓解或更佳率、完全缓解(CR)或更佳率

适应症:Plasma Cell Myeloma

入组条件

纳入标准

  • 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

排除标准

  • 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.

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。