What's the purpose of this trial?
To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months.
This trial is currently open and accepting patients.
What will happen during the trial?
Primary Objective:
To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months
To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice
To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice
To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)
To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)
Secondary Objective:
Not applicable
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
Age ≥18 years
* 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 up to three months before ICF are eligible .
Most important exclusion criteria for potential participants:
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.
Additional Trial Information
Observational Trial
Enrollment: 1,200 patients (estimated)
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