Observational Study of Current Standard Treatments for Adults With Relapsed or Refractory Multiple Myeloma
Led by Janssen Pharmaceutica N.V., Belgium · Updated on 2026-07-06
300
Participants Needed
90
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to observe the real-life effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in adults with previously treated relapsed andor refractory multiple myeloma over a 24-month period. The study focuses on participants receiving routine care for this condition as part of their regular medical treatment.
Participants with relapsed or refractory multiple myeloma undergoing standard antimyeloma treatments in routine clinical practice will be observed. There is no investigational treatment administered by the study instead, medical records will be the primary data source to track treatments and outcomes during the study.
During the study, participants medical records will be reviewed to assess response rates, survival, disease progression, quality of life, and adverse events over up to 52 months. Patient health and well-being will be monitored using standardized questionnaires, and safety will be evaluated through reported side effects. The overall involvement includes observation and data collection without changing the participants treatment plans.
CONDITIONS
Brief Title
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Research Team
S
Study Contact
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Diagnosed with multiple myeloma according to International Myeloma Working Group criteria
For Period 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
For Period 3: ECOG Performance Status of 0, 1, or 2
Not pregnant and not planning pregnancy during the study period
Signed informed consent acknowledging understanding of the study's observational nature
For Period 1 and 2: Received at least 3 prior lines of therapy, each with at least 1 complete cycle unless disease progressed
For Period 1 and 2: Documented progressive disease after last treatment or within previous 6 months with refractory or non-responsive status
Measurable disease at screening as defined by serum or urine monoclonal protein levels or free light chain abnormalities
For Period 1: Prior exposure to a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
For Period 2: Prior exposure to a proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, and BCMA-targeted therapy
For Period 3: Starting talquetamab treatment for relapsed/refractory multiple myeloma with measurable disease or bone lesions
You will not qualify if you...
Pregnant women or those planning pregnancy during the study period
Participants who have not received the required prior therapies or do not meet measurable disease criteria
Participants with ECOG performance status outside the specified grades for each study period
Those who do not provide informed consent to participate in the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit
Observation Period
Duration - Up to 52 months
Participants are observed while receiving standard antimyeloma treatments in routine clinical practice. Researchers collect data from medical records and may use questionnaires to assess health and quality of life.
Visits and assessments as per routine care; data collected regularly
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent.
Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma.
Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma.
Philippe Moreau, María-Victoria Mateos, Maria Esther Gonzalez Garcia...