A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Investigating the Effectiveness and Safety of an Investigational Medication for Relapsed or Refractory Multiple Myeloma, a Type of Cancer Affecting Plasma Cells
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
- 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.
This study investigates the effectiveness of an investigational medication in patients with relapsed or refractory multiple myeloma (RRMM). Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. The purpose of this study is to assess how well patients respond to the treatment in terms of overall response rate, progression-free survival, and duration of response. The study also aims to understand the profiles of patients receiving this treatment, including their demographics and prior treatment history.
Participants in this study will undergo regular assessments to monitor the safety of the investigational medication, which involves tracking any adverse events. Additionally, the study will evaluate the quality of life for participants using specific questionnaires developed for cancer patients. These questionnaires help measure the impact of the treatment on the participants' daily lives and overall well-being.
- Who can participate: Adults aged 18 years or older with relapsed or refractory multiple myeloma who have received at least one prior therapy can participate. Participants must understand and complete study questionnaires, provide informed consent, and may have started the investigational treatment up to three months before the study.
- Study details: Participants will receive the investigational medication as part of routine clinical practice. They will complete questionnaires to assess their quality of life during the study. The study will also involve regular monitoring for any adverse effects related to the treatment.
- Study Timelines: The study will last 2.5 years.
