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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 30, 2025

Interventions

  • Other: No intervention
    • There is no interventional treatment component for participants with RRMM in this study.

Arms, Groups and Cohorts

  • Participants with Relapsed/Refractory Multiple Myeloma
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Overall Response Rate (ORR)
    • Time Frame: Up to 35 months
    • 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).

Secondary Measures

  • Very Good Partial Response (VGPR) Rate
    • Time Frame: Up to 35 months
    • VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.
  • Complete Response (CR) Rate
    • Time Frame: Up to 35 months
    • CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.
  • Stringent Complete Response (sCR) Rate
    • Time Frame: Up to 35 months
    • sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.
  • Minimal Residual Disease (MRD) Negative Rate
    • Time Frame: Up to 35 months
    • MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.
  • Clinical Benefit Rate (CBR)
    • Time Frame: Up to 35 months
    • CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).
  • Duration of Response (DOR)
    • Time Frame: Up to 35 months
    • 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.
  • Time to Response (TTR)
    • Time Frame: Up to 35 months
    • 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.
  • Time to Best Response
    • Time Frame: Up to 35 months
    • Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.
  • Time to Next Treatment (TTNT)
    • Time Frame: Up to 35 months
    • TTNT is defined as the time from diagnosis to the start of the next-line treatment.
  • Progression-free Survival (PFS)
    • Time Frame: Up to 35 months
    • 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.
  • Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)
    • Time Frame: Up to 35 months
    • 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.
  • Overall Survival (OS)
    • Time Frame: Up to 35 months
    • 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.
  • 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
    • Time Frame: Baseline up to 35 months
    • 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.
  • 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)
    • Time Frame: Baseline up to 35 months
    • 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).
  • Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39
    • Time Frame: Baseline up to 35 months
    • 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).
  • Number of Participants with Adverse Events (AEs)
    • Time Frame: Up to 35 months
    • 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.
  • Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    • Time Frame: Up to 35 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Pharmaceutica N.V., Belgium
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study Director, Janssen Pharmaceutica N.V., Belgium
  • Overall Contact(s)
    • Study Contact, 844-434-4210, Participate-In-This-Study@its.jnj.com

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