Clareo Health | A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Duration per participant is 2.5 years
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
