Overview
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 initiated 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
Description
Duration per participant is 2.5 years
Eligibility
- Age 18 years
- Patients with MM who received at least one prior line of therapy and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria, including patients with:
Refractory disease: patients who were refractory to all previous lines of treatment but should have achieved at least a minimal response (MR) in one previous line
Relapsed and refractory disease: patients who were relapsed from at least one previous line of treatment and refractory to the last line of treatment. Patients can be refractory to other previous line/lines of treatment
Note: Patients must have achieved a MR or better to at least one of the previous lines of treatment (i.e., primary refractory disease is not eligible)
- Patients who will be treated with isatuximab, solely determined by the treating physician, and independent of the study
- Able to understand and complete the study-related questionnaires
- Patient must have given signed informed consent prior to study start
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
- Diagnosed or treated for another malignancy within three years prior to study inclusion with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in -situ malignancy, or low risk prostate cancer after curative therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.