NCT05160584

Brief Summary

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
11 countries

87 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Nov 2021Jul 2028

Study Start

First participant enrolled

November 18, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

December 15, 2021

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).

    Up to 52 months

Secondary Outcomes (20)

  • Very Good Partial Response (VGPR) Rate

    Up to 52 months

  • Complete Response (CR) Rate

    Up to 52 months

  • Stringent Complete Response (sCR) Rate

    Up to 52 months

  • Minimal Residual Disease (MRD) Negative Rate

    Up to 52 months

  • Clinical Benefit Rate (CBR)

    Up to 52 months

  • +15 more secondary outcomes

Study Arms (1)

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.

Other: No intervention

Interventions

There is no interventional treatment component for participants with RRMM in this study.

Participants with Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

You may qualify if:

  • For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
  • For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
  • For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
  • For Period 1,2 and 3: Participants must sign an 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
  • For Period 1 and 2: 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
  • For Period 1 and 2: 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: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain \>= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (\>=1 lesion has 2 diameters \>= 1 centimeter \[cm\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (87)

LKH Leoben

Leoben, 8700, Austria

RECRUITING

Krankenhaus der barmherzigen Schwestern

Vienna, 1060, Austria

RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

COMPLETED

Chu Helora Hospital De Mons Site Kennedy

Mons, 7000, Belgium

RECRUITING

Vitaz

Sint-Niklaas, 9100, Belgium

RECRUITING

Ucl de Mont-Godinne

Yvoir, 5530, Belgium

COMPLETED

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

COMPLETED

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295, France

COMPLETED

CHU de Nantes hotel Dieu

Nantes, 44093, France

COMPLETED

Centre hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

COMPLETED

Pôle IUC Oncopole CHU

Toulouse, 31059, France

COMPLETED

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berin, 12203, Germany

COMPLETED

Universitaetsklinikum Koeln

Cologne, 50397, Germany

COMPLETED

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

Dresden, 01307, Germany

COMPLETED

Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

Hamburg, 20251, Germany

COMPLETED

St. Barbara-Klinik Hamm GmbH

Hamm, 59073, Germany

COMPLETED

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

COMPLETED

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany

COMPLETED

MVZ Mitte-Onkologische Schwerpunktpraxis

Leipzig, 04103, Germany

COMPLETED

Universitaetsklinikum Leipzig

Leipzig, 4103, Germany

COMPLETED

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

Tübingen, 72076, Germany

COMPLETED

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

COMPLETED

Heinrich-Braun-Klinikum gGmbH

Zwickau, 08060, Germany

COMPLETED

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

RECRUITING

Henry Dunant Hospital Center

Athens, 115 26, Greece

RECRUITING

Laiko General Hospital Of Athens 1

Athens, 115 27, Greece

RECRUITING

Laiko General Hospital of Athens 2

Athens, 115 27, Greece

RECRUITING

Alexandra Hospital

Athens, 115 28, Greece

RECRUITING

Metaxa Cancer Center Hospital Of Piraeus

Piraeus, 18537, Greece

RECRUITING

General University Hospital of Patras

Rio, 265 04, Greece

RECRUITING

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, 546 39, Greece

RECRUITING

Ahepa University General Hospital of Thessaloniki

Thessaloniki, 54636, Greece

RECRUITING

Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

COMPLETED

U.O. Ematologia Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

RECRUITING

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

Bologna, 40138, Italy

ACTIVE NOT RECRUITING

Policlinico di Catania

Catania, 95128, Italy

COMPLETED

Ospedale Civile di Civitanova Marche

Civitanova Marche, 62012, Italy

RECRUITING

IRCCS Azienda Ospedaliera San Martino - IST

Genova, 16132, Italy

COMPLETED

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

RECRUITING

Ospedale Vito Fazzi

Lecce, 73100, Italy

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

COMPLETED

Universita degli Studi di Padova Azienda Ospedaliera di Pa

Padova, 35128, Italy

COMPLETED

Ospedale Villa Sofia-Cervello

Palermo, 90146, Italy

ACTIVE NOT RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

ACTIVE NOT RECRUITING

Presidio Ospedaliero Pescara

Pescara, 65124, Italy

RECRUITING

Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

Reggio Calabria, 89124, Italy

RECRUITING

Università di Roma La Sapienza

Roma, 00161, Italy

COMPLETED

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168, Italy

ACTIVE NOT RECRUITING

Campus Bio Medico di Roma

Roma, 128, Italy

RECRUITING

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, 71013, Italy

RECRUITING

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

COMPLETED

Ospedale Cardinale G. Panico

Tricase, 73039, Italy

COMPLETED

Azienda Ulss 8 Berica- Ospedale Di Vicenza

Vicenza, 36100, Italy

RECRUITING

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

COMPLETED

UMCG

Groningen, 9713 GZ, Netherlands

COMPLETED

Ulstmad - Hosp. Chaves

Chaves, 5400 482, Portugal

RECRUITING

Uls Coimbra - Hosp. Univ. Coimbra

Coimbra, 3004 561, Portugal

RECRUITING

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319, Portugal

RECRUITING

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 08908, Spain

COMPLETED

Hosp. de Cabuenes

Gijón, 33394, Spain

RECRUITING

Hosp. Univ. Virgen de Las Nieves

Granada, 18014, Spain

RECRUITING

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

COMPLETED

Hosp. de Leon

León, 24008, Spain

RECRUITING

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

COMPLETED

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

COMPLETED

Hosp. Univ. Son Espases

Palma, 7120, Spain

RECRUITING

Clinica Univ. de Navarra

Pamplona, 31008, Spain

COMPLETED

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

RECRUITING

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

COMPLETED

Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

RECRUITING

Hosp. Univ. Dr. Peset

Valencia, 46017, Spain

RECRUITING

Hosp. Clinico Univ. de Valladolid

Valladolid, 47003, Spain

COMPLETED

Hosp. Univ. Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Kantonsspital Graubunden

Chur, 7000, Switzerland

RECRUITING

Kantonsspital Winterthur, Medizinische Onkologie

Winterthur, 8400, Switzerland

RECRUITING

Hirslanden Klinik Hirslanden

Zurich, 8032, Switzerland

RECRUITING

Universitatsspital Zurich

Zurich, 8091, Switzerland

RECRUITING

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

COMPLETED

University College Hospital

London, NW1 2PG, United Kingdom

COMPLETED

Kings College Hospital

London, SE5 9RS, United Kingdom

COMPLETED

St Georges Hospital

London, SW17 OQT, United Kingdom

COMPLETED

Maidstone Hospital

Maidstone, ME16 9QQ, United Kingdom

COMPLETED

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

COMPLETED

The Royal Marsden NHS Trust Sutton

Surrey, SM2 5PT, United Kingdom

COMPLETED

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial

    Janssen Pharmaceutica N.V., Belgium

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 15, 2021

First Posted

December 16, 2021

Study Start

November 18, 2021

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

More information

Locations