A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
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
Condition
- Plasma Cell Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
- 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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1 | Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria |
|
Recruiting Locations
More Details
- NCT ID
- NCT04458831
- Status
- Active, not recruiting
- Sponsor
- Sanofi
Detailed Description
Duration per participant is 2.5 years