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Clinical Trials in the UK / NCT05160584
Recruiting Observational

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

NCT05160584 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Pharmaceutica N.V., Belgium
Phase
Observational
Started
2021-11-18
Last updated
2026-08-28

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

No intervention

No intervention: There is no interventional treatment component for participants with RRMM in this study.

Study summary

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 \[cm\])

Primary outcome measure(s)

Trial sites (90)

FacilityCityRegionStatus
LKH Leoben Leoben Austria Recruiting
Krankenhaus der barmherzigen Schwestern Vienna Austria Recruiting
UZ Antwerpen Edegem Belgium Recruiting
Ziekenhuis Oost-Limburg Genk Belgium Recruiting
UZ Leuven Leuven Belgium Completed
Chu Helora Hospital De Mons Site Kennedy Mons Belgium Recruiting
Vitaz Sint-Niklaas Belgium Recruiting
Ucl de Mont-Godinne Yvoir Belgium Completed
CHRU de Lille Hopital Claude Huriez Lille France Completed
CHU de Montpellier Hopital Saint Eloi Montpellier France Completed
CHU de Nantes hotel Dieu Nantes France Completed
Centre hospitalier Lyon-Sud Pierre-Bénite France Completed
Pôle IUC Oncopole CHU Toulouse France Completed
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berin Germany Completed
Universitaetsklinikum Koeln Cologne Germany Completed
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden Dresden Germany Completed
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik Hamburg Germany Completed
St. Barbara-Klinik Hamm GmbH Hamm Germany Completed
Universitaetsklinikum Heidelberg Heidelberg Germany Completed
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany Completed
MVZ Mitte-Onkologische Schwerpunktpraxis Leipzig Germany Completed
Universitaetsklinikum Leipzig Leipzig Germany Completed
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany Tübingen Germany Completed
Universitatsklinikum Wurzburg Würzburg Germany Completed
Heinrich-Braun-Klinikum gGmbH Zwickau Germany Completed
University Hospital of Alexandroupolis Alexandroupoli Greece Recruiting
Henry Dunant Hospital Center Athens Greece Recruiting
Laiko General Hospital Of Athens 1 Athens Greece Recruiting
Laiko General Hospital of Athens 2 Athens Greece Recruiting
Alexandra Hospital Athens Greece Recruiting
Metaxa Cancer Center Hospital Of Piraeus Piraeus Greece Recruiting
General University Hospital of Patras Rio Greece Recruiting
Anticancer Hospital of Thessaloniki Theageneio Thessaloniki Greece Recruiting
Ahepa University General Hospital of Thessaloniki Thessaloniki Greece Recruiting
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II Bari Italy Completed
U.O. Ematologia Istituto Tumori Giovanni Paolo II Bari Italy Recruiting
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Bologna Italy Recruiting
Policlinico di Catania Catania Italy Completed
Ospedale Civile di Civitanova Marche Civitanova Marche Italy Recruiting
IRCCS Azienda Ospedaliera San Martino - IST Genova Italy Completed

+ 50 more sites — see the full list on the official registry below.

More Janssen Pharmaceutica N.V., Belgium trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05160584 on ClinicalTrials.gov ↗ ← All trials in the UK