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

Investigation of an Investigational Medication in Patients with Relapsed/Refractory Multiple Myeloma

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 use of an investigational medication in patients with relapsed and/or refractory multiple myeloma (RRMM). Multiple myeloma is a type of cancer that affects plasma cells, which are found in the bone marrow. In this study, the effectiveness of the investigational medication will be assessed in terms of overall response rate and other parameters such as progression-free survival and duration of response.

Participants will undergo routine clinical evaluations and complete quality of life questionnaires. The study will also collect information on patient demographics, disease characteristics, and treatment history to better understand the safety and effectiveness of the investigational medication in a real-world setting. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

  • Who can participate: Adults aged 18 and older with relapsed and/or refractory multiple myeloma who have received at least one prior line of therapy may participate. Participants must be able to understand and complete study-related questionnaires and provide informed consent.
  • Study details: Participants will continue their usual care while information is collected about their condition and response to the investigational medication. They will also complete questionnaires about their quality of life.
  • Study timelines: The study will last 2.5 years.

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