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Assessing current treatments for relapsed and refractory multiple myeloma

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

Observational Janssen Pharmaceutica N.V., Belgium · NCT05160584

This study looks at how well current treatments work for people with relapsed and refractory multiple myeloma by tracking their experiences and outcomes over two years.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Pharmaceutica N.V., Belgium Industry-sponsored
Drugs / interventionstalquetamab
Locations87 sites (Leoben and 86 other locations)
Trial IDNCT05160584 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness, safety, and patient-reported outcomes associated with standard of care treatments for patients with relapsed and/or refractory multiple myeloma over a 24-month period. Participants will be monitored to gather real-life data on their treatment experiences and outcomes. The study does not involve any experimental interventions, focusing instead on the current clinical practices in managing this condition.

Who should consider this trial

Good fit: Ideal candidates include individuals with a documented diagnosis of relapsed and/or refractory multiple myeloma who have received at least three prior lines of therapy.

Not a fit: Patients who are newly diagnosed or have not undergone multiple lines of therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of existing treatments, potentially improving patient care and treatment strategies.

How similar studies have performed: Other observational studies have shown success in evaluating real-world treatment outcomes, suggesting that this approach is validated in the field.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
* For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
* For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
* For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
* For Period 1 and 2: 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
* For Period 1 and 2: 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
* For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
* Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
* For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain \>= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (\>=1 lesion has 2 diameters \>= 1 centimeter \[cm\])

Where this trial is running

Leoben and 86 other locations

+37 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Multiple Myeloma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.