UAMS - Translational Research Institute

Condition

• Plasma Cell Myeloma

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 Contact

Detailed Description

Duration per participant is 2.5 years