NCT05160584Active, not recruiting
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 256 (actual)
- First submitted
- 15 Dec 2021
- Start date
- 18 Nov 2021
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Diseases
- Multiple myeloma
- NCT number
- NCT05160584
What you commit to
- Study type: Observational
- Participants enrolled: 256
- From 18 Nov 2021 to the primary completion date, 30 Apr 2028
- 90 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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 \[cm\])
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (90)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LKH Leoben Coordinator of this site? Confirm its status | Leoben | Austria | Unknown status |
| Krankenhaus der barmherzigen Schwestern Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Chu Helora Hospital De Mons Site Kennedy Coordinator of this site? Confirm its status | Mons | Belgium | Unknown status |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
| Ucl de Mont-Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
| Kantonsspital Graubunden Coordinator of this site? Confirm its status | Chur | Switzerland | Unknown status |
| Kantonsspital Winterthur, Medizinische Onkologie Coordinator of this site? Confirm its status | Winterthur | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Hirslanden Klinik Hirslanden Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Coordinator of this site? Confirm its status | Berin | Germany | Unknown status |
| Universitaetsklinikum Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| St. Barbara-Klinik Hamm GmbH Coordinator of this site? Confirm its status | Hamm | Germany | Unknown status |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Staedtisches Klinikum Karlsruhe gGmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Unknown status |
| Universitaetsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| MVZ Mitte-Onkologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Heinrich-Braun-Klinikum gGmbH Coordinator of this site? Confirm its status | Zwickau | Germany | Unknown status |
| Inst. Cat. Doncologia-H Duran I Reynals Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. de Cabuenes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hosp. Univ. Virgen de Las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hosp. de Jerez de La Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| Hosp. de Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hosp. Univ. Ramon Y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hosp. Clinico Univ. de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hosp. Clinico Univ. de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hosp. Univ. Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hosp. Clinico Univ. de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hosp. Univ. Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| CHRU de Lille - Hopital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Montpellier Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Pôle IUC Oncopole CHU Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Georges Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Maidstone Hospital Coordinator of this site? Confirm its status | Maidstone | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| The Royal Marsden NHS Trust Sutton Coordinator of this site? Confirm its status | Surrey | United Kingdom | Unknown status |
| University Hospital of Alexandroupolis Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Unknown status |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Laiko General Hospital of Athens 2 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Laiko General Hospital Of Athens 1 Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Metaxa Cancer Center Hospital Of Piraeus Coordinator of this site? Confirm its status | Piraeus | Greece | Unknown status |
| General University Hospital of Patras Coordinator of this site? Confirm its status | Rio | Greece | Unknown status |
| AHEPA University General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Anticancer Hospital of Thessaloniki Theageneio Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| U.O. Ematologia Istituto Tumori Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Policlinico di Catania Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Ospedale Civile di Civitanova Marche Coordinator of this site? Confirm its status | Civitanova Marche | Italy | Unknown status |
| Ospedale Policlinico San Martino IRCCS Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| IRCCS Azienda Ospedaliera San Martino - IST Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Ospedale Vito Fazzi Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Universita degli Studi di Padova Azienda Ospedaliera di Pa Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Ospedale Villa Sofia-Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Presidio Ospedaliero Pescara Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Campus Bio Medico di Roma Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università di Roma La Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Casa Sollievo Della Sofferenza IRCCS Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| IRCCS Ospedale Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| Ospedale Cardinale G. Panico Coordinator of this site? Confirm its status | Tricase | Italy | Unknown status |
| Azienda Ulss 8 Berica- Ospedale Di Vicenza Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
| VU Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Ulstmad - Hosp. Chaves Coordinator of this site? Confirm its status | Chaves | Portugal | Unknown status |
| Uls Coimbra - Hosp. Univ. Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Uls Sao Joao - Hosp. Sao Joao Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Spitalul Clinic Coltea, Clinica Hematologie Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.