A 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 Austria, Germany, Japan, Puerto Rico, 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.

Investigational Site Number 8400008, Fullerton, California

Status

Recruiting

Address

Investigational Site Number 8400008

Fullerton, California, 92835

Investigational Site Number 8400009, San Francisco, California

Status

Recruiting

Address

Investigational Site Number 8400009

San Francisco, California, 94143

Investigational Site Number 8400007, Jacksonville, Florida

Status

Recruiting

Address

Investigational Site Number 8400007

Jacksonville, Florida, 32204

Investigational Site Number 8400023, Lakeland, Florida

Status

Recruiting

Address

Investigational Site Number 8400023

Lakeland, Florida, 33805

Investigational Site Number 8400025, Pembroke Pines, Florida

Status

Recruiting

Address

Investigational Site Number 8400025

Pembroke Pines, Florida, 33024

Investigational Site Number 8400019, Garden City, Kansas

Status

Recruiting

Address

Investigational Site Number 8400019

Garden City, Kansas, 67846

Investigational Site Number 8400010, Farmington Hills, Michigan

Status

Recruiting

Address

Investigational Site Number 8400010

Farmington Hills, Michigan, 48334

Investigational Site Number 8400006, Bolivar, Missouri

Status

Recruiting

Address

Investigational Site Number 8400006

Bolivar, Missouri, 65613

Investigational Site Number 8400016, Kansas City, Missouri

Status

Recruiting

Address

Investigational Site Number 8400016

Kansas City, Missouri, 64114

Investigational Site Number 8400017, Freehold, New Jersey

Status

Recruiting

Address

Investigational Site Number 8400017

Freehold, New Jersey, 07728

Investigational Site Number 8400024, Howell, New Jersey

Status

Recruiting

Address

Investigational Site Number 8400024

Howell, New Jersey, 07731

Investigational Site Number 8400018, Little Silver, New Jersey

Status

Recruiting

Address

Investigational Site Number 8400018

Little Silver, New Jersey, 07739

Investigational Site Number 84000015, Canton, Ohio

Status

Recruiting

Address

Investigational Site Number 84000015

Canton, Ohio, 44708

Investigational Site Number 8400012, Massillon, Ohio

Status

Recruiting

Address

Investigational Site Number 8400012

Massillon, Ohio, 44646

Investigational Site Number 8400020, Charleston, South Carolina

Status

Recruiting

Address

Investigational Site Number 8400020

Charleston, South Carolina, 29414

Investigational Site Number 8400011, Greenville, South Carolina

Status

Recruiting

Address

Investigational Site Number 8400011

Greenville, South Carolina, 29615

Investigational Site Number 8400013, Houston, Texas

Status

Recruiting

Address

Investigational Site Number 8400013

Houston, Texas, 77030

International Sites

Investigational site number 400002, Steyr, Austria

Status

Recruiting

Address

Investigational site number 400002

Steyr, , 4400

Investigational Site Number 2760014, Aschaffenburg, Germany

Status

Recruiting

Address

Investigational Site Number 2760014

Aschaffenburg, , 63739

Investigational Site Number 2760016, Aschaffenburg, Germany

Status

Recruiting

Address

Investigational Site Number 2760016

Aschaffenburg, , 63739

Investigational Site Number 2760025, Bad Liebenwerda, Germany

Status

Recruiting

Address

Investigational Site Number 2760025

Bad Liebenwerda, , 04924

Investigational Site Number 2760020, Bamberg, Germany

Status

Recruiting

Address

Investigational Site Number 2760020

Bamberg, , 96052

Investigational Site Number 2760003, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number 2760003

Berlin, , 10117

Investigational Site Number 2760009, Berlin, Germany

Status

Recruiting

Address

Investigational Site Number 2760009

Berlin, , 10715

Investigational Site Number 2760007, Donauwörth, Germany

Status

Recruiting

Address

Investigational Site Number 2760007

Donauwörth, , 86609

Investigational site number 2760001, Dortmund, Germany

Status

Recruiting

Address

Investigational site number 2760001

Dortmund, , 44263

Investigational Site Number 2760010, Frankfurt, Germany

Status

Recruiting

Address

Investigational Site Number 2760010

Frankfurt, , 60389

Investigational Site Number 2760015, Goslar, Germany

Status

Recruiting

Address

Investigational Site Number 2760015

Goslar, , 38642

Investigational Site Number 2760012, Hanover, Germany

Status

Recruiting

Address

Investigational Site Number 2760012

Hanover, , 30449

Investigational Site Number 2760013, Herrsching Am Ammersee, Germany

Status

Recruiting

Address

Investigational Site Number 2760013

Herrsching Am Ammersee, , 82211

Investigational Site Number 2760008, Leipzig, Germany

Status

Recruiting

Address

Investigational Site Number 2760008

Leipzig, , 04289

Investigational Site Number 2760006, Muenchen, Germany

Status

Recruiting

Address

Investigational Site Number 2760006

Muenchen, , 81241

Investigational Site Number 2760021, Oldenburg, Germany

Status

Recruiting

Address

Investigational Site Number 2760021

Oldenburg, , 26121

Investigational Site Number 2760019, Würzburg, Germany

Status

Recruiting

Address

Investigational Site Number 2760019

Würzburg, , 97080

Investigational Site Number 3920005, Okayama, Japan

Status

Recruiting

Address

Investigational Site Number 3920005

Okayama, , 701-1192

Investigational Site Number 3920001, Yamagata-shi, Japan

Status

Recruiting

Address

Investigational Site Number 3920001

Yamagata-shi, , 990-9585

Investigational Site Number 8400001, Hato Rey, Puerto Rico

Status

Recruiting

Address

Investigational Site Number 8400001

Hato Rey, , 00917