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| ID | Type | Description | Link |
|---|---|---|---|
| 64407564MMY4001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | There is no interventional treatment component for participants with RRMM in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Very Good Partial Response (VGPR) Rate | VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria. | Up to 52 months |
| Complete Response (CR) Rate |
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Inclusion Criteria:
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The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium Clinical Trial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Leoben | Recruiting | Leoben | 8700 | Austria | ||
| Krankenhaus der barmherzigen Schwestern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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, 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. | |
| 38402374 |
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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.
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CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.
| Up to 52 months |
| Stringent Complete Response (sCR) Rate | sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria. | Up to 52 months |
| Minimal Residual Disease (MRD) Negative Rate | MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria. | Up to 52 months |
| Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR). | Up to 52 months |
| Duration of Response (DOR) | DOR 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 as defined in the IMWG criteria. | Up to 52 months |
| Time to Response (TTR) | TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response. | Up to 52 months |
| Time to Best Response | Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response. | Up to 52 months |
| Time to Next Treatment (TTNT) | TTNT is defined as the time from diagnosis to the start of the next-line treatment. | Up to 52 months |
| 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 (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first. | Up to 52 months |
| Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (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. | Up to 52 months |
| Overall Survival (OS) | OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first. | Up to 52 months |
| Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score | The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Baseline up to 52 months |
| Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) | The EQ-5D-5L is a generic measure of health status. The 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). | Baseline up to 52 months |
| Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39 | EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) 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). | Baseline up to 52 months |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 52 months |
| 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. | Up to 52 months |
| Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | PRO-CTCAE consist of 1-8 questions of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. The following items were selected for inclusion for patients with multiple myeloma: nausea, vomiting, diarrhea, shortness of breath, rash, dizziness, headache, taste changes, and fatigue/tiredness/lack of energy. | Up to 52 months |
| Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS) | The Epstein Taste Survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. Developed for use in patients with head and neck cancer. | Up to 52 months |
| Period 3: Percentage of Participants with Overall Response to Subsequent Therapies | 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). Overall response for subsequent therapies, including BCMA-targeted therapies after treatment with talquetamab will be reported. | Up to 52 months |
| Recruiting |
| Vienna |
| 1060 |
| Austria |
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
| Ziekenhuis Oost-Limburg | Recruiting | Genk | 3600 | Belgium |
| UZ Leuven | Completed | Leuven | 3000 | Belgium |
| Chu Helora Hospital De Mons Site Kennedy | Recruiting | Mons | 7000 | Belgium |
| Vitaz | Recruiting | Sint-Niklaas | 9100 | Belgium |
| Ucl de Mont-Godinne | Completed | Yvoir | 5530 | Belgium |
| CHRU de Lille Hopital Claude Huriez | Completed | Lille | 59037 | France |
| CHU de Montpellier Hopital Saint Eloi | Completed | Montpellier | 34295 | France |
| CHU de Nantes hotel Dieu | Completed | Nantes | 44093 | France |
| Centre hospitalier Lyon-Sud | Completed | Pierre-Bénite | 69495 | France |
| Pôle IUC Oncopole CHU | Completed | Toulouse | 31059 | France |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Completed | Berin | 12203 | Germany |
| Universitaetsklinikum Koeln | Completed | Cologne | 50397 | Germany |
| Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden | Completed | Dresden | 01307 | Germany |
| Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik | Completed | Hamburg | 20251 | Germany |
| St. Barbara-Klinik Hamm GmbH | Completed | Hamm | 59073 | Germany |
| Universitaetsklinikum Heidelberg | Completed | Heidelberg | 69120 | Germany |
| Staedtisches Klinikum Karlsruhe gGmbH | Completed | Karlsruhe | Germany |
| MVZ Mitte-Onkologische Schwerpunktpraxis | Completed | Leipzig | 04103 | Germany |
| Universitaetsklinikum Leipzig | Completed | Leipzig | 4103 | Germany |
| Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany | Completed | Tübingen | 72076 | Germany |
| Universitatsklinikum Wurzburg | Completed | Würzburg | 97080 | Germany |
| Heinrich-Braun-Klinikum gGmbH | Completed | Zwickau | 08060 | Germany |
| University Hospital of Alexandroupolis | Recruiting | Alexandroupoli | 68100 | Greece |
| Henry Dunant Hospital Center | Recruiting | Athens | 115 26 | Greece |
| Laiko General Hospital Of Athens 1 | Recruiting | Athens | 115 27 | Greece |
| Laiko General Hospital of Athens 2 | Recruiting | Athens | 115 27 | Greece |
| Alexandra Hospital | Recruiting | Athens | 115 28 | Greece |
| Metaxa Cancer Center Hospital Of Piraeus | Recruiting | Piraeus | 18537 | Greece |
| General University Hospital of Patras | Recruiting | Rio | 265 04 | Greece |
| Anticancer Hospital of Thessaloniki Theageneio | Recruiting | Thessaloniki | 546 39 | Greece |
| Ahepa University General Hospital of Thessaloniki | Recruiting | Thessaloniki | 54636 | Greece |
| Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II | Completed | Bari | 70124 | Italy |
| U.O. Ematologia Istituto Tumori Giovanni Paolo II | Recruiting | Bari | 70124 | Italy |
| Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
| Policlinico di Catania | Completed | Catania | 95128 | Italy |
| Ospedale Civile di Civitanova Marche | Recruiting | Civitanova Marche | 62012 | Italy |
| IRCCS Azienda Ospedaliera San Martino - IST | Completed | Genova | 16132 | Italy |
| Ospedale Policlinico San Martino IRCCS | Recruiting | Genova | 16132 | Italy |
| Ospedale Vito Fazzi | Recruiting | Lecce | 73100 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Completed | Meldola | 47014 | Italy |
| Universita degli Studi di Padova Azienda Ospedaliera di Pa | Completed | Padova | 35128 | Italy |
| Ospedale Villa Sofia-Cervello | Recruiting | Palermo | 90146 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
| Presidio Ospedaliero Pescara | Recruiting | Pescara | 65124 | Italy |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria | Recruiting | Reggio Calabria | 89124 | Italy |
| Università di Roma La Sapienza | Completed | Roma | 00161 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| Campus Bio Medico di Roma | Recruiting | Roma | 128 | Italy |
| Casa Sollievo Della Sofferenza IRCCS | Recruiting | San Giovanni Rotondo | 71013 | Italy |
| IRCCS Ospedale Casa Sollievo della Sofferenza | Completed | San Giovanni Rotondo | 71013 | Italy |
| Ospedale Cardinale G. Panico | Completed | Tricase | 73039 | Italy |
| Azienda Ulss 8 Berica- Ospedale Di Vicenza | Recruiting | Vicenza | 36100 | Italy |
| VU Medisch Centrum | Completed | Amsterdam | 1081 HV | Netherlands |
| UMCG | Completed | Groningen | 9713 GZ | Netherlands |
| Ulstmad - Hosp. Chaves | Recruiting | Chaves | 5400 482 | Portugal |
| Uls Coimbra - Hosp. Univ. Coimbra | Recruiting | Coimbra | 3004 561 | Portugal |
| Uls Sao Joao - Hosp. Sao Joao | Recruiting | Porto | 4200 319 | Portugal |
| Fundeni Clinical Institute | Recruiting | Bucharest | 022328 | Romania |
| Spitalul Clinic Coltea, Clinica Hematologie | Recruiting | Bucharest | Romania |
| Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1 | Recruiting | Cluj-Napoca | 400015 | Romania |
| Inst. Cat. Doncologia-H Duran I Reynals | Completed | Barcelona | 08908 | Spain |
| Hosp. de Cabuenes | Recruiting | Gijón | 33394 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Recruiting | Granada | 18014 | Spain |
| Hosp. de Jerez de La Frontera | Completed | Jerez de la Frontera | 11407 | Spain |
| Hosp. de Leon | Recruiting | León | 24008 | Spain |
| Hosp. Univ. Ramon Y Cajal | Completed | Madrid | 28034 | Spain |
| Hosp. Univ. 12 de Octubre | Completed | Madrid | 28041 | Spain |
| Hosp. Univ. Son Espases | Recruiting | Palma | 7120 | Spain |
| Clinica Univ. de Navarra | Completed | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hosp. Clinico Univ. de Santiago | Completed | Santiago de Compostela | 15706 | Spain |
| Hosp. Clinico Univ. de Valencia | Recruiting | Valencia | 46010 | Spain |
| Hosp. Univ. Dr. Peset | Recruiting | Valencia | 46017 | Spain |
| Hosp. Clinico Univ. de Valladolid | Completed | Valladolid | 47003 | Spain |
| Hosp. Univ. Miguel Servet | Recruiting | Zaragoza | 50009 | Spain |
| Kantonsspital Graubunden | Recruiting | Chur | 7000 | Switzerland |
| Kantonsspital Winterthur, Medizinische Onkologie | Recruiting | Winterthur | 8400 | Switzerland |
| Hirslanden Klinik Hirslanden | Recruiting | Zurich | 8032 | Switzerland |
| Universitatsspital Zurich | Recruiting | Zurich | 8091 | Switzerland |
| Southmead Hospital | Completed | Bristol | BS10 5NB | United Kingdom |
| University College Hospital | Completed | London | NW1 2PG | United Kingdom |
| Kings College Hospital | Completed | London | SE5 9RS | United Kingdom |
| St Georges Hospital | Completed | London | SW17 OQT | United Kingdom |
| Maidstone Hospital | Completed | Maidstone | ME16 9QQ | United Kingdom |
| Nottingham University Hospitals NHS Trust | Completed | Nottingham | NG5 1PB | United Kingdom |
| The Royal Marsden NHS Trust Sutton | Completed | Surrey | SM2 5PT | United Kingdom |
| 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. |
| 38110653 | 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. |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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