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

Sanofi

Status

Enrolling

Conditions

Plasma Cell Myeloma

Treatments

Drug: Pomalidomide

Drug: isatuximab SAR650984

Drug: Dexamethasone

Drug: Carfilzomib

Study type

Observational

Funder types

Industry

Identifiers

NCT04458831

OBS16577

Details and patient eligibility

About

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

Full description

Duration per participant is 2.5 years

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.