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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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