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RECRUITING

NCT05160584

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

Sponsor: Janssen Pharmaceutica N.V., Belgium

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2021-11-18

Completion Date

2028-07-31

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Relapsed/Refractory Multiple Myeloma

Interventions

OTHER

No intervention

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

Inclusion Criteria: * 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 \[cm\])

Locations (86)

LKH Leoben

Leoben, Austria

Krankenhaus der barmherzigen Schwestern

Vienna, Austria

Ziekenhuis Oost-Limburg

Genk, Belgium

UZ Leuven

Leuven, Belgium

Chu Helora Hospital De Mons Site Kennedy

Mons, Belgium

Vitaz

Sint-Niklaas, Belgium

Ucl de Mont-Godinne

Yvoir, Belgium

CHRU de Lille Hopital Claude Huriez

Lille, France

CHU de Montpellier Hopital Saint Eloi

Montpellier, France

CHU de Nantes hotel Dieu

Nantes, France

Centre hospitalier Lyon-Sud

Pierre-Bénite, France

Pôle IUC Oncopole CHU

Toulouse, France

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

Dresden, Germany

Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

Hamburg, Germany

St. Barbara-Klinik Hamm GmbH

Hamm, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany

MVZ Mitte-Onkologische Schwerpunktpraxis

Leipzig, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

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

Tübingen, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

Heinrich-Braun-Klinikum gGmbH

Zwickau, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

Henry Dunant Hospital Center

Athens, Greece

Laiko General Hospital Of Athens 1

Athens, Greece

Laiko General Hospital of Athens 2

Athens, Greece

Alexandra Hospital

Athens, Greece

Metaxa Cancer Center Hospital Of Piraeus

Piraeus, Greece

General University Hospital of Patras

Rio, Greece

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, Greece

Ahepa University General Hospital of Thessaloniki

Thessaloniki, Greece

Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

Bari, Italy

U.O. Ematologia Istituto Tumori Giovanni Paolo II

Bari, Italy

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

Bologna, Italy

Policlinico di Catania

Catania, Italy

Ospedale Civile di Civitanova Marche

Civitanova Marche, Italy

IRCCS Azienda Ospedaliera San Martino - IST

Genova, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Ospedale Vito Fazzi

Lecce, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Universita degli Studi di Padova Azienda Ospedaliera di Pa

Padova, Italy

Ospedale Villa Sofia-Cervello

Palermo, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Presidio Ospedaliero Pescara

Pescara, Italy

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

Reggio Calabria, Italy

Università di Roma La Sapienza

Roma, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Campus Bio Medico di Roma

Roma, Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Ospedale Cardinale G. Panico

Tricase, Italy

Azienda Ulss 8 Berica- Ospedale Di Vicenza

Vicenza, Italy

VU Medisch Centrum

Amsterdam, Netherlands

UMCG

Groningen, Netherlands

Ulstmad - Hosp. Chaves

Chaves, Portugal

Uls Coimbra - Hosp. Univ. Coimbra

Coimbra, Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, Portugal

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, Spain

Hosp. de Cabuenes

Gijón, Spain

Hosp. Univ. Virgen de Las Nieves

Granada, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. de Leon

León, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. Son Espases

Palma, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Hosp. Univ. Dr. Peset

Valencia, Spain

Hosp. Clinico Univ. de Valladolid

Valladolid, Spain

Hosp. Univ. Miguel Servet

Zaragoza, Spain

Kantonsspital Graubunden

Chur, Switzerland

Kantonsspital Winterthur, Medizinische Onkologie

Winterthur, Switzerland

Hirslanden Klinik Hirslanden

Zurich, Switzerland

Universitatsspital Zurich

Zurich, Switzerland

Southmead Hospital

Bristol, United Kingdom

University College Hospital

London, United Kingdom

Kings College Hospital

London, United Kingdom

St Georges Hospital

London, United Kingdom

Maidstone Hospital

Maidstone, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

The Royal Marsden NHS Trust Sutton

Surrey, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (86)