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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04458831
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sanofi
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Sciences & Operations
Principal Investigator Affiliation	Sanofi
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Kuwait, Netherlands, Puerto Rico, Russian Federation, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Plasma Cell Myeloma

Additional Details

Duration per participant is 2.5 years

Arms & Interventions

Arms

: Cohort 1

Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria

Interventions

Drug: - isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

Drug: - Pomalidomide

Pharmaceutical form: oral

Drug: - Dexamethasone

Pharmaceutical form: oral

Drug: - Carfilzomib

Pharmaceutical form: solution for infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas Medical Sciences Site Number : 8400021

Little Rock, Arkansas, 72205-7199

Site Contact

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