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

NCT04035226 | Completed

• 2 other identifiers: CR10865168284528MMY4001
• Study Type: observational
• Target: 254
• Locations: 10 countries
• Sites: 75

Brief Summary

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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the percentage of patients who achieve a partial response (PR) or better according to the international myeloma working group (IMWG) response criteria.

  Up to 24 months

Secondary Outcomes (16)

• Very Good Partial Response (VGPR) Rate

  Up to 24 months

• Complete Response (CR) Rate

  Up to 24 months

• Stringent Complete Response (sCR) Rate

  Up to 24 months

• Minimal Residual Disease (MRD) Negative Rate

  Up to 24 months

• Clinical Benefit Rate (CBR)

  Up to 24 months

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention will be administered as a part of this study.

Relapsed/refractory Multiple Myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The main source of data collection will be medical records of each patient.

You may qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead
• Legend Biotech: collaborator

Study Sites (75)

Oncology Institute of Hope and Innovation

Glendale, California, 91204, United States

Location

Marin Cancer Center

Greenbrae, California, 94904, United States

Location

Asclepes Research

Weeki Wachee, Florida, 34607, United States

Location

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

Peoria, Illinois, 61615, United States

Location

Providence Cancer Center

Southfield, Michigan, 48075, United States

Location

Central Care Cancer Center

Bolivar, Missouri, 65613, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Optum Care

Las Vegas, Nevada, 89102, United States

Location

Hunterdon Hematology Oncology

Flemington, New Jersey, 08822, United States

Location

The Cancer Institute at St. Francis Hospital

East Hills, New York, 11548, United States

Location

North Shore Hematology Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Grand Hopital de Charleroi, site Notre Dame

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Ucl de Mont-Godinne

Yvoir, 5530, Belgium

Location

Centre Hospitalier du Mans

Le Mans, 72000, France

Location

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

Lille, 59000, France

Location

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295, France

Location

C.H.U. Hotel Dieu - France

Nantes, 44093, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

Hopital Saint-Antoine

Paris, 75571, France

Location

Centre hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers - Hopital la Miletrie

Poitiers, 86021, France

Location

Pôle IUC Oncopole CHU

Toulouse, 31059, France

Location

Universitaetsklinikum Koelnt

Cologne, 50397, Germany

Location

Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

Hamburg, 20251, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Medizinische Klinik A

Münster, 48149, Germany

Location

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

Tübingen, 72076, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

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

Bari, 70124, Italy

Location

U.O. Ematologia Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

Location

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

Bologna, 40138, Italy

Location

Policlinico di Catania

Catania, 95128, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

IRCCS Azienda Ospedaliera San Martino - IST

Genova, 16132, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

Location

Universita degli Studi di Padova Azienda Ospedaliera di Pa

Padua, 35128, Italy

Location

Ospedale Villa Sofia-Cervello

Palermo, 90146, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Irccs Crob

Rionero in Vulture, 85028, Italy

Location

Università di Roma La Sapienza

Roma, 00161, Italy

Location

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Ospedale Cardinale G. Panico

Tricase, 73039, Italy

Location

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

Turin, 10126, Italy

Location

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

Erasmus MC - Satellite

Rotterdam, 3075 EA, Netherlands

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, 20-081, Poland

Location

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

Poznan, 60 569, Poland

Location

S.P. Botkin Moscow City Clinical Hospital

Moscow, 125284, Russia

Location

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, 191024, Russia

Location

Samara Region Clinical Hospital

Samara, 443095, Russia

Location

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 08908, Spain

Location

Hosp. Puerta Del Mar

Cadiz, 11009, Spain

Location

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

Location

Hosp. de Leon

León, 24008, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. Son Espases

Palma, 7120, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Hosp. Mutua Terrassa

Terrassa, 08221, Spain

Location

Hosp. Univ. Dr. Peset

Valencia, 46017, Spain

Location

Hosp. Clinico Univ. de Valladolid

Valladolid, 47003, Spain

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Maidstone Hospital

Kent, ME16 9QQ, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

St George's Hospital

London, SW17 OQT, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

The Royal Marsden NHS Trust Sutton

Surrey, SM2 5PT, United Kingdom

Location

Related Publications (7)

• 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, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2025 Nov 28. doi: 10.1007/s12325-025-03409-y. Online ahead of print.

  PMID: 41313549 DERIVED

• 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.

  PMID: 38402374 DERIVED

• 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.

  PMID: 38212206 DERIVED

• 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.

  PMID: 38110653 DERIVED

• 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.

  PMID: 36961654 DERIVED

• 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.

  PMID: 36546453 DERIVED

• 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.

  PMID: 35332278 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: August 2, 2019
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9); BE (4); RU (3); NL (3); ES (13); GB (7); IT (16); PL (2); DE (6); US (12)