Status:
ACTIVE_NOT_RECRUITING
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Lead Sponsor:
Sanofi
Conditions:
Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Duration per participant is 2.5 years
Eligibility Criteria
Inclusion
- Age ≥18 years or country's legal age of majority if the legal age is \>18 years old at the time of enrollment
- 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 or whose treatment is still ongoing at 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. Further eligibility criteria might apply.
Exclusion
Key Trial Info
Start Date :
August 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 23 2026
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT04458831
Start Date
August 13 2020
End Date
February 23 2026
Last Update
June 27 2025
Active Locations (129)
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1
University of Arkansas Medical Sciences Site Number : 8400021
Little Rock, Arkansas, United States, 72205-7199
2
St. Joseph Heritage Healthcare Site Number : 8400008
Fullerton, California, United States, 92835
3
University of California San Francisco (PARENT) Site Number : 8400009
San Francisco, California, United States, 94143
4
Holy Cross Hospital Site Number : 8400030
Fort Lauderdale, Florida, United States, 33308