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

What's the purpose of this trial?

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months.

This trial is currently open and accepting patients.


What will happen during the trial?

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

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Observational Trial

Enrollment: 1,200 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Open and Accepting

California

St Joseph Heritage Healthcare

Fullerton, CA

Open and Accepting

UCSF Medical Center (Parnassus)

San Francisco, CA

Open and Accepting

Florida

Holy Cross Hospital

Fort Lauderdale, FL

Open and Accepting

GenesisCare

Jacksonville, FL

Open and Accepting

Millennium Oncology Research Clinic

Pembroke Pines, FL

Open and Accepting

Comprehensive Hematology and Oncology

Saint Petersburg, FL

Open and Accepting

Kansas

Central Care Cancer Center (Heartland)

Garden City, KS

Open and Accepting

Maine

Central Maine Medical Center

Lewiston, ME

Open and Accepting

Michigan

Michigan Center of Medical Research

Farmington Hills, MI

Open and Accepting

Missouri

Alliance for Multi-Specialty Research

Kansas City, MO

Open and Accepting

New Jersey

Regional Cancer Care Associates

Freehold Township, NJ

Open and Accepting

Regional Cancer Care Associates

Howell Township, NJ

Open and Accepting

Regional Cancer Care Associates - Little Silver

Little Silver, NJ

Open and Accepting

North Carolina

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Ohio

Hematology & Oncology Associates

Canton, OH

Open and Accepting

Tri-County Hematology and Oncology

Massillon, OH

Open and Accepting

South Carolina

Charleston Hematology Oncology Associates PA West Ashley

Charleston, SC

Open and Accepting

Prisma Health Cancer Institute - Eastside Eastside

Greenville, SC

Open and Accepting

South Dakota

Prairie Lakes Health Care System

Watertown, SD

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Renovatio Clinical

The Woodlands, TX

Open and Accepting
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