A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Study on the Effectiveness of Investigational Medication for RRMM

Recruiting
18 years or above
All
Phase N/A
1200 participants needed
17 Locations

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
  • Age: 18 years or above
  • 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.

Updated on 16 May 2024. Study ID: NCT04458831

This study investigates the effectiveness of an investigational medication for 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 in the bone marrow. Relapsed or refractory means that the cancer has returned after treatment or is not responding to treatment. The purpose of this study is to evaluate how well the investigational medication works in routine clinical practice by measuring the overall response rate, progression-free survival, and other effectiveness parameters.

Participants in the study will undergo various procedures, including assessments of their health and quality of life using specific questionnaires. These questionnaires are designed to understand the impact of the disease and treatment on the participants' daily lives. The safety of the investigational medication will also be monitored through reports of any adverse events experienced by the participants.

  • Who can participate: Adults aged 18 years or older with relapsed or refractory multiple myeloma who have had at least one prior line of therapy may participate. Participants must be able to understand and complete study questionnaires and have given informed consent, unless a waiver is applicable for deceased retrospective participants.
  • Study details: Participants will receive the investigational medication as part of their routine clinical care, as decided by their treating physician. They will be asked to complete questionnaires about their quality of life and health status. Safety will be monitored through reports of any adverse events.
  • Study Timelines: The study will last 2.5 years.

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