A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Official Title
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A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

Conditions
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Relapsed/Refractory Multiple Myeloma

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1 Must not be pregnant or must not plan to become pregnant within the study period Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Relapsed/Refractory Multiple Myeloma<br>Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant. | Other: No intervention<br>* There is no interventional treatment component for participants with RRMM in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC). | Up to 35 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Very Good Partial Response (VGPR) Rate | VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria. | Up to 35 months | 
| Complete Response (CR) Rate | CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria. | Up to 35 months | 
| Stringent Complete Response (sCR) Rate | sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria. | Up to 35 months | 
| Minimal Residual Disease (MRD) Negative Rate | MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria. | Up to 35 months | 
| Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR). | Up to 35 months | 
| Duration of Response (DOR) | DOR is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease as defined in the IMWG criteria. | Up to 35 months | 
| Time to Response (TTR) | TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response. | Up to 35 months | 
| Time to Best Response | Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response. | Up to 35 months | 
| Time to Next Treatment (TTNT) | TTNT is defined as the time from diagnosis to the start of the next-line treatment. | Up to 35 months | 
| Progression-free Survival (PFS) | PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first. | Up to 35 months | 
| Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2) | PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first. | Up to 35 months | 
| Overall Survival (OS) | OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first. | Up to 35 months | 
| Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score | The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Baseline up to 35 months | 
| Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) | The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline up to 35 months | 
| Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39 | EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much). | Baseline up to 35 months | 
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 35 months | 
| Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event. | Up to 35 months |