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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort 1 Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
  • Drug: isatuximab SAR650984
    Pharmaceutical form: solution for infusion Route of administration: intravenous
    Other names:
    • Sarclisa
  • Drug: Pomalidomide
    Pharmaceutical form: oral
    Other names:
    • Pomalyst
  • Drug: Dexamethasone
    Pharmaceutical form: oral
  • Drug: Carfilzomib
    Pharmaceutical form: solution for infusion

Recruiting Locations

Investigational Site Number 8400021
Little Rock, Arkansas 72205

Investigational Site Number 8400008
Fullerton, California 92835

Investigational Site Number 8400009
San Francisco, California 94143

Investigational Site Number 8400007
Jacksonville, Florida 32204

Investigational Site Number 8400023
Lakeland, Florida 33805

Investigational Site Number 8400025
Pembroke Pines, Florida 33024

Investigational Site Number 8400026
Saint Petersburg, Florida 33709

Investigational Site Number 8400019
Garden City, Kansas 67846

Investigational Site Number 8400010
Farmington Hills, Michigan 48334

Investigational Site Number 8400006
Bolivar, Missouri 65613

Investigational Site Number 8400016
Kansas City, Missouri 64114

Investigational Site Number 8400017
Freehold, New Jersey 07728

Investigational Site Number 8400024
Howell, New Jersey 07731

Investigational Site Number 8400018
Little Silver, New Jersey 07739

Investigational Site Number 8400015
Canton, Ohio 44708

Investigational Site Number 8400012
Massillon, Ohio 44646

Investigational Site Number 8400020
Charleston, South Carolina 29414

Investigational Site Number 8400011
Greenville, South Carolina 29615

Investigational Site Number 8400013
Houston, Texas 77030

Investigational Site Number 8400001
Hato Rey, Puerto Rico 00917

More Details

NCT ID
NCT04458831
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
Contact-Us@sanofi.com

Detailed Description

Duration per participant is 2.5 years

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.