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Search / Trial NCT05160584

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

Launched by JANSSEN PHARMACEUTICA N.V., BELGIUM · Dec 15, 2021

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how well current treatments for multiple myeloma work in everyday medical practice. Specifically, it focuses on patients who have already received treatment for their multiple myeloma, but their disease has either come back or did not respond to previous therapies. The trial will last for 24 months and aims to see how safe and effective these standard treatments are for these patients in a real-world setting.

To be eligible for the study, participants need to have a confirmed diagnosis of multiple myeloma and must have had at least three previous treatment attempts. They should also be well enough to participate, with a performance status that indicates they can carry out daily activities. Importantly, women who are pregnant or planning to become pregnant during the study cannot take part. Those who join the trial will be monitored closely to gather information on how their disease responds to the treatments they receive. This study is currently looking for participants, so it's a great opportunity for those who meet the criteria and are seeking further treatment options.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • For Period 1, 2 and 3
  • Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
  • 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
  • Participants must sign an informed consent form (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
  • 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
  • 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: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level .5 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

About Janssen Pharmaceutica N.V., Belgium

Janssen Pharmaceutica N.V., based in Belgium, is a leading pharmaceutical company dedicated to the research, development, and commercialization of innovative therapies across a range of therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. As a subsidiary of Johnson & Johnson, Janssen leverages cutting-edge science and state-of-the-art technology to address unmet medical needs and improve patient outcomes globally. With a strong commitment to clinical research and collaboration, Janssen Pharmaceutica strives to advance healthcare through the discovery of novel treatments, ensuring high standards of safety and efficacy in all its clinical trials.

Locations

London, , United Kingdom

Bristol, , United Kingdom

Maidstone, , United Kingdom

Nottingham, , United Kingdom

Amsterdam, , Netherlands

London, , United Kingdom

Pierre Bénite, , France

Heidelberg, , Germany

Leoben, , Austria

Leuven, , Belgium

Würzburg, , Germany

Paris Cedex 10, , France

Lille, , France

Pavia, , Italy

Salamanca, , Spain

Santiago De Compostela, , Spain

Meldola, , Italy

London, , United Kingdom

Yvoir, , Belgium

Athens, , Greece

Lille, , France

Lecce, , Italy

Alexandroupoli, , Greece

Lille, , France

San Giovanni Rotondo, , Italy

Wuerzburg, , Germany

London, , United Kingdom

Groningen, , Netherlands

Zwickau, , Germany

Leipzig, , Germany

Würzburg, , Germany

San Giovanni Rotondo, , Italy

Heidelberg, Baden Wuerttemberg, Germany

Madrid, , Spain

Madrid, , Spain

Santander, , Spain

Valencia, , Spain

Roma, , Italy

Reggio Calabria, , Italy

Pamplona, , Spain

Palermo, , Italy

Genova, , Italy

Valencia, , Spain

Bologna, , Italy

Nantes Cedex 1, , France

Roma, , Italy

Granada, , Spain

Leon, , Spain

Muenster, , Germany

Zaragoza, , Spain

Barcelona, , Spain

Sint Niklaas, , Belgium

Wien, , Austria

Athens, , Greece

Bari, , Italy

Jerez De La Frontera, , Spain

Koeln, , Germany

Genova, , Italy

Rome, , Italy

Palma, , Spain

Vicenza, , Italy

Toulouse Cedex 9, , France

Hamburg, , Germany

Tübingen, , Germany

Catania, , Italy

Padova, , Italy

Tricase, , Italy

Valladolid, , Spain

Surrey, , United Kingdom

Dresden, , Germany

Leipzig, , Germany

Gijón, , Spain

Genk, Limburg, Belgium

Montpellier Cedex 5, , France

Poitiers Cedex, , France

Berin, , Germany

Hamm, , Germany

Leon, , Spain

Koeln, , Germany

Nantes Cedex 1, , France

Tubingen, , Germany

Nantes Cedex 1, , France

Roma, , Italy

Padova, , Italy

Thessaloniki, , Greece

London, , United Kingdom

Roma, , Italy

Salamanca, , Spain

Montpellier Cedex 5, , France

Karlsruhe, , Germany

Leipzig, , Germany

Mons, , Belgium

Rio, , Greece

Peiraias, , Greece

Civitanova Marche, , Italy

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Study Director

Janssen Pharmaceutica N.V., Belgium

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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