A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment
NCT ID: NCT04035226
Last Updated: 2025-03-30
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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COMPLETED
254 participants
OBSERVATIONAL
2019-08-02
2022-10-27
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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Relapsed/refractory Multiple Myeloma
Patients with relapsed/refractory multiple myeloma who received at least 3 prior lines of therapy including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody treatment will be observed.
No intervention
No intervention will be administered as a part of this study.
Interventions
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No intervention
No intervention will be administered as a part of this study.
Eligibility Criteria
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Inclusion Criteria
* Received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response)
* Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible
* 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
18 Years
ALL
No
Sponsors
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Legend Biotech
UNKNOWN
Janssen-Cilag Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag Ltd. Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Ltd.
Locations
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Oncology Institute of Hope and Innovation
Glendale, California, United States
Marin Cancer Center
Greenbrae, California, United States
Asclepes Research
Weeki Wachee, Florida, United States
Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.
Peoria, Illinois, United States
Providence Cancer Center
Southfield, Michigan, United States
Central Care Cancer Center
Bolivar, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Optum Care
Las Vegas, Nevada, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, United States
The Cancer Institute at St. Francis Hospital
East Hills, New York, United States
North Shore Hematology Oncology Associates, P.C.
East Setauket, New York, United States
The Ohio State University
Columbus, Ohio, United States
Grand Hopital de Charleroi, site Notre Dame
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Ucl de Mont-Godinne
Yvoir, , Belgium
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Lille, , France
CHU de Montpellier Hopital Saint Eloi
Montpellier, , France
C.H.U. Hotel Dieu - France
Nantes, , France
Hopital Saint Louis
Paris, , France
Hopital Saint-Antoine
Paris, , France
Centre hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU Poitiers - Hopital la Miletrie
Poitiers, , France
Pôle IUC Oncopole CHU
Toulouse, , France
Universitaetsklinikum Koelnt
Cologne, , Germany
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Medizinische Klinik A
Münster, , Germany
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tübingen, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
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
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
IRCCS Azienda Ospedaliera San Martino - IST
Genova, , 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
Irccs Crob
Rionero in Vulture, , Italy
Università di Roma La Sapienza
Roma, , Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Ospedale Cardinale G. Panico
Tricase, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin, , Italy
VU Medisch Centrum
Amsterdam, , Netherlands
UMCG
Groningen, , Netherlands
Erasmus MC - Satellite
Rotterdam, , Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, , Poland
Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
Poznan, , Poland
S.P. Botkin Moscow City Clinical Hospital
Moscow, , Russia
Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, , Russia
Samara Region Clinical Hospital
Samara, , Russia
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, , Spain
Hosp. Puerta Del Mar
Cadiz, , 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. Mutua Terrassa
Terrassa, , Spain
Hosp. Univ. Dr. Peset
Valencia, , Spain
Hosp. Clinico Univ. de Valladolid
Valladolid, , Spain
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Maidstone Hospital
Kent, , United Kingdom
Kings College Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey, , United Kingdom
Countries
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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.
Mateos MV, Weisel K, Diels J, Arribas A, Tamayo M, Schecter JM, Roccia T, Haddad I, Pacaud L, Moreau P. Characterization and Outcomes of Spanish Patients With Relapsed/Refractory Multiple Myeloma Included in the LocoMMotion Study. Clin Lymphoma Myeloma Leuk. 2024 Apr;24(4):224-231.e2. doi: 10.1016/j.clml.2023.12.001. Epub 2023 Dec 7.
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.
Moreau P, van de Donk NWCJ, Delforge M, Einsele H, De Stefano V, Perrot A, Besemer B, Pawlyn C, Karlin L, Manier S, Leleu X, Weisel K, Ghilotti F, Diels J, Elsada A, Morano R, Strulev V, Pei L, Kobos R, Smit J, Slavcev M, Mateos MV. Comparative Efficacy of Teclistamab Versus Current Treatments in Real-World Clinical Practice in the Prospective LocoMMotion Study in Patients with Triple-Class-Exposed Relapsed and/or Refractory Multiple Myeloma. Adv Ther. 2023 May;40(5):2412-2425. doi: 10.1007/s12325-023-02480-7. Epub 2023 Mar 24.
Mateos MV, Weisel K, Martin T, Berdeja JG, Jakubowiak A, Stewart AK, Jagannath S, Lin Y, Diels J, Ghilotti F, Thilakarathne P, Perualila NJ, Cabrieto J, Haefliger B, Erler-Yates N, Hague C, Jackson CC, Schecter JM, Strulev V, Nesheiwat T, Pacaud L, Einsele H, Moreau P. Adjusted comparison of outcomes between patients from CARTITUDE-1 versus multiple myeloma patients with prior exposure to proteasome inhibitors, immunomodulatory drugs and anti-CD38 antibody from the prospective, multinational LocoMMotion study of real-world clinical practice. Haematologica. 2023 Aug 1;108(8):2192-2204. doi: 10.3324/haematol.2022.280482.
Mateos MV, Weisel K, De Stefano V, Goldschmidt H, Delforge M, Mohty M, Cavo M, Vij R, Lindsey-Hill J, Dytfeld D, Angelucci E, Perrot A, Benjamin R, van de Donk NWCJ, Ocio EM, Scheid C, Gay F, Roeloffzen W, Rodriguez-Otero P, Broijl A, Potamianou A, Sakabedoyan C, Semerjian M, Keim S, Strulev V, Schecter JM, Vogel M, Wapenaar R, Nesheiwat T, San-Miguel J, Sonneveld P, Einsele H, Moreau P. LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma. Leukemia. 2022 May;36(5):1371-1376. doi: 10.1038/s41375-022-01531-2. Epub 2022 Mar 24.
Other Identifiers
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68284528MMY4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108651
Identifier Type: -
Identifier Source: org_study_id
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