A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
NCT ID: NCT05160584
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-11-18
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with Relapsed/Refractory Multiple Myeloma
Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.
No intervention
There is no interventional treatment component for participants with RRMM in this study.
Interventions
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No intervention
There is no interventional treatment component for participants with RRMM in this study.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutica N.V., Belgium Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium
Locations
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LKH Leoben
Leoben, , Austria
Krankenhaus der barmherzigen Schwestern
Vienna, , Austria
Ziekenhuis Oost-Limburg
Genk, , Belgium
UZ Leuven
Leuven, , Belgium
Chu Helora Hospital De Mons Site Kennedy
Mons, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Ucl de Mont-Godinne
Yvoir, , Belgium
CHRU de Lille Hopital Claude Huriez
Lille, , France
CHU de Montpellier Hopital Saint Eloi
Montpellier, , France
CHU de Nantes hotel Dieu
Nantes, , France
Centre hospitalier Lyon-Sud
Pierre-Bénite, , France
Pôle IUC Oncopole CHU
Toulouse, , France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
Dresden, , Germany
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
Hamburg, , Germany
St. Barbara-Klinik Hamm GmbH
Hamm, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
MVZ Mitte-Onkologische Schwerpunktpraxis
Leipzig, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tübingen, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Heinrich-Braun-Klinikum gGmbH
Zwickau, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Henry Dunant Hospital Center
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
Alexandra Hospital
Athens, , Greece
Metaxa Cancer Center Hospital Of Piraeus
Piraeus, , Greece
General University Hospital of Patras
Rio, , Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, , Greece
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, , Italy
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, , Italy
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna, , Italy
Policlinico di Catania
Catania, , Italy
Ospedale Civile di Civitanova Marche
Civitanova Marche, , Italy
IRCCS Azienda Ospedaliera San Martino - IST
Genova, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padua, , Italy
Ospedale Villa Sofia-Cervello
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Presidio Ospedaliero Pescara
Pescara, , Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, , Italy
Università di Roma La Sapienza
Roma, , Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, , Italy
Campus Bio Medico di Roma
Roma, , Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Ospedale Cardinale G. Panico
Tricase, , Italy
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, , Italy
VU Medisch Centrum
Amsterdam, , Netherlands
UMCG
Groningen, , Netherlands
Ulstmad - Hosp. Chaves
Chaves, , Portugal
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, , Spain
Hosp. de Cabuenes
Gijón, , Spain
Hosp. Univ. Virgen de Las Nieves
Granada, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. de Leon
León, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. Son Espases
Palma, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Hosp. Univ. Dr. Peset
Valencia, , Spain
Hosp. Clinico Univ. de Valladolid
Valladolid, , Spain
Hosp. Univ. Miguel Servet
Zaragoza, , Spain
Kantonsspital Graubunden
Chur, , Switzerland
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur, , Switzerland
Hirslanden Klinik Hirslanden
Zurich, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Southmead Hospital
Bristol, , United Kingdom
University College Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
St Georges Hospital
London, , United Kingdom
Maidstone Hospital
Maidstone, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey, , United Kingdom
Countries
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Central Contacts
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References
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Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19.
Other Identifiers
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64407564MMY4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR109118
Identifier Type: -
Identifier Source: org_study_id