Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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 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 initiated 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

Details

Duration per participant is 2.5 years

Keywords

Plasma Cell Myeloma Multiple Myeloma Neoplasms, Plasma Cell Dexamethasone Pomalidomide isatuximab SAR650984 Carfilzomib

Eligibility

For people ages 18 years and up

  • Age ≥18 years
  • Patients who are are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria.
  • Patients who are isatuximab-naïve and for whom the treating physician has made the decision to initiate isatuximab prior to patient inclusion and independently of the purpose of the study
  • Able to understand and complete the study-related questionnaires
  • Patient must have given signed informed consent prior to study start

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
  • Diagnosed or treated for another malignancy within three years prior to study inclusion with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in -situ malignancy, or low risk prostate cancer after curative therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations

  • Investigational Site Number 8400009 accepting new patients
    San Francisco California 94143 United States
  • Investigational Site Number 8400008 accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT04458831
Study Type
Observational [Patient Registry]
Last Updated