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

Primary outcomes

1. Overall response rate (ORR)

   Time frame: 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

2. Progression free survival (PFS)

   Time frame: 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.

3. Progression free survival rate (PFSR)

   Time frame: up to 18 months

   The proportion of patients who do not progress and are alive at a specific time intervals

4. Duration of response (DoR)

   Time frame: 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.

5. Time to response (TTR)

   Time frame: 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

6. Time to first subsequent anti-myeloma therapy

   Time frame: Up to 30 months

   Time from the initiation of isatuximab until the start of subsequent therapy or death.

7. Rate of very good partial response or better

   Time frame: 12 months

   Comprising VGPR, CR, and sCR within 12 months

8. Rate of complete response (CR) or better

   Time frame: 12 months

   Comprising CR and sCR responses within 12 months

9. Number of Participants with Adverse events

   Time frame: 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

10. 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)

    Time frame: 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.

11. Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)

    Time frame: 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).