A Prospective Non-interventional Multinational Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

  • STATUS
    Recruiting
  • End date
    Oct 5, 2025
  • participants needed
    1300
  • sponsor
    Sanofi
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Updated on 19 February 2024
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cancer
multiple myeloma
carcinoma
refractory multiple myeloma
isatuximab
line of therapy
complete resection

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

Description

Duration per participant is 2.5 years

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age 18-100 years
Treatment Isatuximab SAR650984
Clinical Study IdentifierNCT04458831
SponsorSanofi
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Age \\u226518 years'
b'Patients with MM who received at least one prior line of therapy and are considered as'
b'RRMM according to the International Myeloma Working Group (IMWG) criteria, including'
b'patients with:'
b'Refractory disease: patients who were refractory to all previous lines of treatment but'
b'hould have achieved at least a minimal response (MR) in one previous line'
b'Relapsed and refractory disease: patients who were relapsed from at least one previous line'
b'of treatment and refractory to the last line of treatment. Patients can be refractory to'
b'other previous line/lines of treatment'
b'Note: Patients must have achieved a MR or better to at least one of the previous lines of'
b'treatment (i.e., primary refractory disease is not eligible)'
b'Patients who will be treated with isatuximab, solely determined by the treating'
b'physician, and independent of the study'
b'Able to understand and complete the study-related questionnaires'
b'Patient must have given signed informed consent prior to study start'
b'Most important exclusion criteria for potential participants:'
b'Patients who are receiving isatuximab for an indication other than RRMM'
b'Patients who have received any other investigational drug or prohibited therapy for'
b'this study within 28 days or five half-lives from randomization, whichever is longer'
b'Patients having contraindication to the isatuximab summary of product characteristics'
b'(SMPC) or package insert (PI)'
b'Patients having contraindications as noted in the drug-specific local isatuximab'
b'SMPC/PI of combination drugs'
b'Any country-related specific regulation that would prevent the patient from entering'
b'the study'
b'Diagnosed or treated for another malignancy within three years prior to study'
b'cell carcinoma of the skin, an in -situ malignancy, or low risk prostate cancer after'
b'curative therapy'
b"The above information is not intended to contain all considerations relevant to a patient's"
b'potential participation in a clinical trial.'
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