Actively Recruiting
A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed andor Refractory Multiple Myeloma
Led by Janssen Pharmaceutica N.V., Belgium · Updated on 2026-06-05
300
Participants Needed
89
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in people with relapsed andor refractory multiple myeloma over a 24-month period. This observational study focuses on participants who have previously received treatment and aims to understand real-life clinical practice outcomes. The study is sponsored by Janssen Pharmaceutica N.V., Belgium, and collects data from routine medical care without interventional treatments. Participants with relapsedrefractory multiple myeloma receiving standard antimyeloma treatments as part of their regular clinical care will be observed. The primary source of data will be the participants medical records. There is no experimental drug or placebo involved. The study includes different observation periods to assess various outcomes related to response rates, disease progression, and quality of life. During the study, researchers will review participants medical records and track a wide range of outcomes including overall response rate, progression-free survival, adverse events, and health-related quality of life using validated questionnaires. The study follows participants for up to 52 months, monitoring treatment responses, safety, and patient-reported oral toxicities. This long-term observation helps to understand treatment effectiveness and patient experiences in everyday clinical settings.
CONDITIONS
Brief Title
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a documented diagnosis of multiple myeloma according to International Myeloma Working Group diagnostic criteria (Periods 1, 2, and 3 with specific timing and treatment distinctions)
- For Periods 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1; for Period 3: ECOG grade of 0, 1, or 2
- Must not be pregnant or planning pregnancy during the study period
- Must sign informed consent form indicating understanding and willingness to participate
- For Periods 1 and 2: Received at least 3 prior lines of therapy with at least 1 complete treatment cycle for each, unless progressive disease was best response
- For Periods 1 and 2: Have documented evidence of progressive disease per IMWG criteria on or after last regimen or be refractory/non-responsive within previous 6 months
- For Periods 1 and 2: Measurable disease at screening as defined by specific serum or urine monoclonal protein levels or light chain criteria
- For Period 1: Prior therapy includes a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
- For Period 2: Prior therapy includes proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, and BCMA-targeted therapy
- For Period 3: Measurable disease at screening or presence of bone lesions or plasmacytomas meeting defined criteria
You will not qualify if you...
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