A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

Официальное название

A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

Обзор

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.

Вмешательства

• Другое No intervention
  There is no interventional treatment component for participants with RRMM in this study.

Первичные конечные точки

• Overall Response Rate (ORR) [Срок оценки: Up to 52 months]

Вторичные конечные точки (12)

• Very Good Partial Response (VGPR) Rate [Срок оценки: Up to 52 months]
• Complete Response (CR) Rate [Срок оценки: Up to 52 months]
• Stringent Complete Response (sCR) Rate [Срок оценки: Up to 52 months]
• Minimal Residual Disease (MRD) Negative Rate [Срок оценки: Up to 52 months]
• Clinical Benefit Rate (CBR) [Срок оценки: Up to 52 months]
• Duration of Response (DOR) [Срок оценки: Up to 52 months]
• Time to Response (TTR) [Срок оценки: Up to 52 months]
• Time to Best Response [Срок оценки: Up to 52 months]
• Time to Next Treatment (TTNT) [Срок оценки: Up to 52 months]
• Progression-free Survival (PFS) [Срок оценки: Up to 52 months]
• Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2) [Срок оценки: Up to 52 months]
• Overall Survival (OS) [Срок оценки: Up to 52 months]

Критерии участия

Критерии включения

• 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 \[cm\])

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 21 центр

• Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II — Bari
• U.O. Ematologia Istituto Tumori Giovanni Paolo II — Bari
• Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Ma — Bologna
• Policlinico di Catania — Catania
• Ospedale Civile di Civitanova Marche — Civitanova Marche
• IRCCS Azienda Ospedaliera San Martino - IST — Genova
• Ospedale Policlinico San Martino IRCCS — Genova
• Ospedale Vito Fazzi — Lecce
• … и ещё 13 центров

Испания · 16 центров

• Inst. Cat. Doncologia-H Duran I Reynals — Barcelona
• Hosp. de Cabuenes — Gijón
• Hosp. Univ. Virgen de Las Nieves — Granada
• Hosp. de Jerez de La Frontera — Jerez de la Frontera
• Hosp. de Leon — León
• Hosp. Univ. Ramon Y Cajal — Madrid
• Hosp. Univ. 12 de Octubre — Madrid
• Hosp. Univ. Son Espases — Palma
• … и ещё 8 центров

Германия · 12 центров

• Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin — Berin
• Universitaetsklinikum Koeln — Cologne
• Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden — Dresden
• Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik — Hamburg
• St. Barbara-Klinik Hamm GmbH — Hamm
• Universitaetsklinikum Heidelberg — Heidelberg
• Staedtisches Klinikum Karlsruhe gGmbH — Karlsruhe
• MVZ Mitte-Onkologische Schwerpunktpraxis — Leipzig
• … и ещё 4 центра

Греция · 9 центров

• University Hospital of Alexandroupolis — Alexandroupoli
• Henry Dunant Hospital Center — Athens
• Laiko General Hospital Of Athens 1 — Athens
• Laiko General Hospital of Athens 2 — Athens
• Alexandra Hospital — Athens
• Metaxa Cancer Center Hospital Of Piraeus — Piraeus
• General University Hospital of Patras — Rio
• Anticancer Hospital of Thessaloniki Theageneio — Thessaloniki
• … и ещё 1 центр

Великобритания · 7 центров

Список центров уточняется — проверьте первичный протокол.

Бельгия · 6 центров

• UZ Antwerpen — Edegem
• Ziekenhuis Oost-Limburg — Genk
• UZ Leuven — Leuven
• Chu Helora Hospital De Mons Site Kennedy — Mons
• Vitaz — Sint-Niklaas
• Ucl de Mont-Godinne — Yvoir

Франция · 5 центров

• CHRU de Lille Hopital Claude Huriez — Lille
• CHU de Montpellier Hopital Saint Eloi — Montpellier
• CHU de Nantes hotel Dieu — Nantes
• Centre hospitalier Lyon-Sud — Pierre-Bénite
• Pôle IUC Oncopole CHU — Toulouse

Швейцария · 4 центра

• Kantonsspital Graubunden — Chur
• … и ещё 3 центра

Португалия · 3 центра

• Ulstmad - Hosp. Chaves — Chaves
• Uls Coimbra - Hosp. Univ. Coimbra — Coimbra
• Uls Sao Joao - Hosp. Sao Joao — Porto

Румыния · 3 центра

• Fundeni Clinical Institute — Bucharest
• Spitalul Clinic Coltea, Clinica Hematologie — Bucharest
• Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1 — Cluj-Napoca

Австрия · 2 центра

• LKH Leoben — Leoben
• Krankenhaus der barmherzigen Schwestern — Vienna

Нидерланды · 2 центра

• VU Medisch Centrum — Amsterdam
• UMCG — Groningen

Публикации

• 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 Ef PMID 41313549
• 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 Pa PMID 38402374
• 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 Phys PMID 38110653

Идентификаторы

NCT: NCT05160584 · CR109118 · 64407564MMY4001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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