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Multiple MyelomaLocoMMotionNCT04035226

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

An observational study of Multiple Myeloma, run by Janssen-Cilag Ltd. at 75 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
254 participants
Where
75 sitesin 10 countries
Study dates
2 Aug 2019to 27 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

75 sites in 10 countries.

75 sites in 10 countries

Italy16 sites

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

    Bari, 70124

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124

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

    Bologna, 40138

  • Policlinico di Catania

    Catania, 95128

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • IRCCS Azienda Ospedaliera San Martino - IST

    Genova, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    Padova, 35128

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Irccs Crob

    Rionero in Vulture, 85028

  • Università di Roma La Sapienza

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Ospedale Cardinale G. Panico

    Tricase, 73039

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

    Turin, 10126

Other trials in Italy

Spain13 sites

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908

  • Hosp. Puerta Del Mar

    Cadiz, 11009

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. de Leon

    León, 24008

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. Son Espases

    Palma, 7120

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Mutua Terrassa

    Terrassa, 08221

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003

Other trials in Spain

United States12 sites

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • The Ohio State University

    Columbus, Ohio, 43210

  • The Cancer Institute at St. Francis Hospital

    East Hills, New York, 11548

  • North Shore Hematology Oncology Associates, P.C.

    East Setauket, New York, 11733

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822

  • Oncology Institute of Hope and Innovation

    Glendale, California, 91204

  • Marin Cancer Center

    Greenbrae, California, 94904

  • Optum Care

    Las Vegas, Nevada, 89102

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

    Peoria, Illinois, 61615

  • Providence Cancer Center

    Southfield, Michigan, 48075

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Asclepes Research

    Weeki Wachee, Florida, 34607

Other trials in United States

France9 sites

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille, 59000

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295

  • C.H.U. Hotel Dieu - France

    Nantes, 44093

  • Hopital Saint Louis

    Paris, 75475

  • Hopital Saint-Antoine

    Paris, 75571

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • Pôle IUC Oncopole CHU

    Toulouse, 31059

Other trials in France

United Kingdom7 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Southmead Hospital

    Bristol, BS10 5NB

  • Maidstone Hospital

    Kent, ME16 9QQ

  • Kings College Hospital

    London, SE5 9RS

  • St George's Hospital

    London, SW17 OQT

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT

Other trials in United Kingdom

Germany6 sites

  • Universitaetsklinikum Koelnt

    Cologne, 50397

  • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

    Hamburg, 20251

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Medizinische Klinik A

    Münster, 48149

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

    Tübingen, 72076

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Belgium4 sites

  • Grand Hopital de Charleroi, site Notre Dame

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

  • Ucl de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Netherlands3 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • UMCG

    Groningen, 9713 GZ

  • Erasmus MC - Satellite

    Rotterdam, 3075 EA

Other trials in Netherlands

Russia3 sites

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

  • Samara Region Clinical Hospital

    Samara, 443095

Other trials in Russia

Poland2 sites

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, 20-081

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

    Poznan, 60 569

Other trials in Poland

About this study

Official title: A Prospective, Multinational 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 PI, IMID, and CD38 Monoclonal Antibody Treatment

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).

Being tested
No intervention
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

Study groups in NCT04035226
Study groupRoleWhat they receive
Relapsed/refractory Multiple MyelomaPatients 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.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months

Secondary outcomes (16)

  1. Very Good Partial Response (VGPR) Rate

    VGPR rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

    Measured: Up to 24 months

  2. Complete Response (CR) Rate

    CR rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.

    Measured: Up to 24 months

  3. Stringent Complete Response (sCR) Rate

    sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.

    Measured: Up to 24 months

  4. Minimal Residual Disease (MRD) Negative Rate

    Minimal residual disease (MRD) negative rate is defined as the percentage of patients with negative MRD status according to IMWG response criteria.

    Measured: Up to 24 months

  5. Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of patients with clinical benefit. CBR = ORR (sCR + CR + VGPR + PR) + minimal response (MR).

    Measured: Up to 24 months

  6. Duration of Response

    Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (according to IMWG criteria).

    Measured: Up to 24 months

  7. Time to Response

    Time to response is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the patient has met all criteria for PR or better response.

    Measured: Up to 24 months

  8. Time to Next Treatment [TTNT]

    Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.

    Measured: Up to 24 months

  9. Progression-free Survival (PFS)

    PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (according to IMWG response criteria) or death due to any cause, whichever occurs first.

    Measured: Up to 24 months

  10. Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2)

    PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first.

    Measured: Up to 24 months

  11. Overall Survival (OS)

    Overall survival is the duration from the date of Day 1 of Cycle 1 to the date of the patient's death or study completion, whichever occurs first.

    Measured: Up to 24 months

  12. Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score

    The EORTC QLQ-C30 version 3 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater health-related quality-of-life (HRQoL), better functioning, and more (worse) symptoms.

    Measured: Baseline up to 24 months

  13. Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score

    The EORTC QLQ-MY20 was designed to use alongside the EORTC QLQ-C30 to address issues of more relevance to myeloma patients. Four single items from the EORTC QLQ-MY20 will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much).

    Measured: Baseline up to 24 months

  14. Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score

    EuroQol Five Dimension (EQ-5D-5L) is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline up to 24 months

  15. Number of Patients with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 24 months

  16. Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start2 Aug 2019
  3. Primary completion27 Oct 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04035226
Sponsor's protocol ID
CR108651
Other IDs
68284528MMY4001
Acronym
LocoMMotion
Status last verified
Mar 2025
First submitted
25 Jul 2019
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.

    PubMed 41313549

  • Mateos MV, Weisel K, De Stefano V, Goldschmidt H, Delforge M, Mohty M, Dytfeld D, Angelucci E, Vincent L, Perrot A, Benjamin R, van de Donk NWCJ, Ocio EM, Roccia T, Schecter JM, Koskinen S, Haddad I, Strulev V, Mitchell L, Buyze J, Filho OC, Einsele H, Moreau P. LocoMMotion: a study of real-life current standards of care in triple-class exposed patients with relapsed/refractory multiple myeloma - 2-year follow-up (final analysis). Leukemia. 2024 Dec;38(12):2554-2560. doi: 10.1038/s41375-024-02404-6. Epub 2024 Sep 25.

    PubMed 39322709

  • 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.

    PubMed 38402374

  • 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.

    PubMed 38212206

  • 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.

    PubMed 38110653

  • 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.

    PubMed 36961654

  • 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.

    PubMed 36546453

  • 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.

    PubMed 35332278

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Janssen-Cilag Ltd. at 75 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Italy, Spain, United States, France, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035226, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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