No intervention: There is no interventional treatment component for participants with RRMM in this study.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 \[cm\])
Primary outcome measure(s)
Overall Response Rate (ORR) — Up to 52 months 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).
Trial sites (90)
Facility
City
Region
Status
LKH Leoben
Leoben
Austria
Recruiting
Krankenhaus der barmherzigen Schwestern
Vienna
Austria
Recruiting
UZ Antwerpen
Edegem
Belgium
Recruiting
Ziekenhuis Oost-Limburg
Genk
Belgium
Recruiting
UZ Leuven
Leuven
Belgium
Completed
Chu Helora Hospital De Mons Site Kennedy
Mons
Belgium
Recruiting
Vitaz
Sint-Niklaas
Belgium
Recruiting
Ucl de Mont-Godinne
Yvoir
Belgium
Completed
CHRU de Lille Hopital Claude Huriez
Lille
France
Completed
CHU de Montpellier Hopital Saint Eloi
Montpellier
France
Completed
CHU de Nantes hotel Dieu
Nantes
France
Completed
Centre hospitalier Lyon-Sud
Pierre-Bénite
France
Completed
Pôle IUC Oncopole CHU
Toulouse
France
Completed
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berin
Germany
Completed
Universitaetsklinikum Koeln
Cologne
Germany
Completed
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
Dresden
Germany
Completed
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
Hamburg
Germany
Completed
St. Barbara-Klinik Hamm GmbH
Hamm
Germany
Completed
Universitaetsklinikum Heidelberg
Heidelberg
Germany
Completed
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe
Germany
Completed
MVZ Mitte-Onkologische Schwerpunktpraxis
Leipzig
Germany
Completed
Universitaetsklinikum Leipzig
Leipzig
Germany
Completed
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tübingen
Germany
Completed
Universitatsklinikum Wurzburg
Würzburg
Germany
Completed
Heinrich-Braun-Klinikum gGmbH
Zwickau
Germany
Completed
University Hospital of Alexandroupolis
Alexandroupoli
Greece
Recruiting
Henry Dunant Hospital Center
Athens
Greece
Recruiting
Laiko General Hospital Of Athens 1
Athens
Greece
Recruiting
Laiko General Hospital of Athens 2
Athens
Greece
Recruiting
Alexandra Hospital
Athens
Greece
Recruiting
Metaxa Cancer Center Hospital Of Piraeus
Piraeus
Greece
Recruiting
General University Hospital of Patras
Rio
Greece
Recruiting
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki
Greece
Recruiting
Ahepa University General Hospital of Thessaloniki
Thessaloniki
Greece
Recruiting
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari
Italy
Completed
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari
Italy
Recruiting
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna
Italy
Recruiting
Policlinico di Catania
Catania
Italy
Completed
Ospedale Civile di Civitanova Marche
Civitanova Marche
Italy
Recruiting
IRCCS Azienda Ospedaliera San Martino - IST
Genova
Italy
Completed
+ 50 more sites — see the full list on the official registry below.
More Janssen Pharmaceutica N.V., Belgium trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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