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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-02

Study Completion Date

2022-10-27

Brief Summary

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The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Legend Biotech

UNKNOWN

Sponsor Role collaborator

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Marin Cancer Center

Greenbrae, California, United States

Site Status

Asclepes Research

Weeki Wachee, Florida, United States

Site Status

Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.

Peoria, Illinois, United States

Site Status

Providence Cancer Center

Southfield, Michigan, United States

Site Status

Central Care Cancer Center

Bolivar, Missouri, United States

Site Status

Washington University School Of Medicine

St Louis, Missouri, United States

Site Status

Optum Care

Las Vegas, Nevada, United States

Site Status

Hunterdon Hematology Oncology

Flemington, New Jersey, United States

Site Status

The Cancer Institute at St. Francis Hospital

East Hills, New York, United States

Site Status

North Shore Hematology Oncology Associates, P.C.

East Setauket, New York, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Grand Hopital de Charleroi, site Notre Dame

Charleroi, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Ucl de Mont-Godinne

Yvoir, , Belgium

Site Status

Centre Hospitalier du Mans

Le Mans, , France

Site Status

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

Lille, , France

Site Status

CHU de Montpellier Hopital Saint Eloi

Montpellier, , France

Site Status

C.H.U. Hotel Dieu - France

Nantes, , France

Site Status

Hopital Saint Louis

Paris, , France

Site Status

Hopital Saint-Antoine

Paris, , France

Site Status

Centre hospitalier Lyon-Sud

Pierre-Bénite, , France

Site Status

CHU Poitiers - Hopital la Miletrie

Poitiers, , France

Site Status

Pôle IUC Oncopole CHU

Toulouse, , France

Site Status

Universitaetsklinikum Koelnt

Cologne, , Germany

Site Status

Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

Hamburg, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Medizinische Klinik A

Münster, , Germany

Site Status

Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

Tübingen, , Germany

Site Status

Universitatsklinikum Wurzburg

Würzburg, , Germany

Site Status

U.O. Ematologia con Trapianto- AOU Policlinico di Bari

Bari, , Italy

Site Status

U.O. Ematologia Istituto Tumori Giovanni Paolo II

Bari, , Italy

Site Status

Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

Policlinico di Catania

Catania, , Italy

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

IRCCS Azienda Ospedaliera San Martino - IST

Genova, , Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Site Status

Universita degli Studi di Padova Azienda Ospedaliera di Pa

Padua, , Italy

Site Status

Ospedale Villa Sofia-Cervello

Palermo, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Irccs Crob

Rionero in Vulture, , Italy

Site Status

Università di Roma La Sapienza

Roma, , Italy

Site Status

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, , Italy

Site Status

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Ospedale Cardinale G. Panico

Tricase, , Italy

Site Status

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Turin, , Italy

Site Status

VU Medisch Centrum

Amsterdam, , Netherlands

Site Status

UMCG

Groningen, , Netherlands

Site Status

Erasmus MC - Satellite

Rotterdam, , Netherlands

Site Status

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, , Poland

Site Status

Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

Poznan, , Poland

Site Status

S.P. Botkin Moscow City Clinical Hospital

Moscow, , Russia

Site Status

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, , Russia

Site Status

Samara Region Clinical Hospital

Samara, , Russia

Site Status

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, , Spain

Site Status

Hosp. Puerta Del Mar

Cadiz, , Spain

Site Status

Hosp. de Jerez de La Frontera

Jerez de la Frontera, , Spain

Site Status

Hosp. de Leon

León, , Spain

Site Status

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Site Status

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status

Hosp. Univ. Son Espases

Palma, , Spain

Site Status

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Site Status

Hosp. Mutua Terrassa

Terrassa, , Spain

Site Status

Hosp. Univ. Dr. Peset

Valencia, , Spain

Site Status

Hosp. Clinico Univ. de Valladolid

Valladolid, , Spain

Site Status

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status

Southmead Hospital

Bristol, , United Kingdom

Site Status

Maidstone Hospital

Kent, , United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

St George's Hospital

London, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

The Royal Marsden NHS Trust Sutton

Surrey, , United Kingdom

Site Status

Countries

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United States Belgium France Germany Italy Netherlands Poland Russia Spain United Kingdom

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.

Reference Type DERIVED
PMID: 38402374 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38212206 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38110653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36961654 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36546453 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35332278 (View on PubMed)

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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