Plasma Cell Myeloma
Conditions
Brief 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 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
Detailed description
Duration per participant is 2.5 years
Interventions
Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUGPomalidomide
Pharmaceutical form: oral
DRUGDexamethasone
Pharmaceutical form: oral
DRUGCarfilzomib
Pharmaceutical form: solution for infusion
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 12 months | The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria |
| Progression free survival (PFS) | Up to 30 months | Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first. |
| Progression free survival rate (PFSR) | up to 18 months | The proportion of patients who do not progress and are alive at a specific time intervals |
| Duration of response (DoR) | Up to 30 months | Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR, VGPR, CR, or sCR) to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first. |
| Time to response (TTR) | Up to 30 months | Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria |
| Time to first subsequent anti-myeloma therapy | Up to 30 months | Time from the initiation of isatuximab until the start of subsequent therapy or death. |
| Rate of very good partial response or better | 12 months | Comprising VGPR, CR, and sCR within 12 months |
| Rate of complete response (CR) or better | 12 months | Comprising CR and sCR responses within 12 months |
| Number of Participants with Adverse events | Up to 1 month after the end of treatment | Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: infusion associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second primary malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion |
| Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30) | through end of treatment (up to approximately 2 years) | EORTC QLQ-MY20 standardized scores: The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact. |
| Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20) | through end of treatment (up to approximately 2 years) | EORTC QLQ-C30 standardized scores: The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). |
Countries
Argentina, Austria, Belgium, China, France, Germany, Greece, Hong Kong, Italy, Japan, Kuwait, Netherlands, Puerto Rico, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom, United States
Outcome results
None listed