A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Study of Investigational Medication in Relapsed or Refractory Multiple Myeloma
Study 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 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
Study Details
Duration per participant is 2.5 years
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Plasma Cell Myeloma
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Age: 18 years or above
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Gender: All
- 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
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. Further eligibility criteria might apply.
This study investigates the use of an investigational medication in patients with relapsed and/or refractory multiple myeloma (RRMM). In RRMM, the disease has returned or is resistant to treatment after initial therapy. The purpose of this study is to observe the effectiveness of the medication in routine clinical practice by measuring the overall response rate, progression-free survival, and other response parameters.
Participants will not receive any additional treatment beyond their routine clinical care. The study involves observing patients who are already receiving the investigational medication as part of their standard treatment. Researchers will collect data on patient demographics, disease characteristics, and prior treatment history. They will also monitor safety through adverse event reports and assess quality of life using specific questionnaires.
- Who can participate: Adults aged 18 years or older with relapsed or refractory multiple myeloma who have received at least one prior line of therapy may participate. Participants must already be receiving the investigational medication as decided by their treating physician and be able to complete study-related questionnaires.
- Study details: Participants will continue their routine clinical care while data is collected. The study is observational, meaning no additional treatments or interventions will be administered. Safety and quality of life will be monitored through routine assessments and questionnaires.
- Study timelines: The study will last 2.5 years.
