A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
- Relapsed/Refractory Multiple Myeloma
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Enrolment target
- 300
- Started
- 18 November 2021
- Main results due
- 30 April 2028
- Study sites
- 90
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 \[cm\])
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(90)
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
Ospedale Policlinico San Martino IRCCS
Genova, Italy
Recruiting
Ospedale Vito Fazzi
Lecce, Italy
Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Completed
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, Italy
Completed
Ospedale Villa Sofia-Cervello
Palermo, Italy
Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Recruiting
Presidio Ospedaliero Pescara
Pescara, Italy
Recruiting
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, Italy
Recruiting
Università di Roma La Sapienza
Roma, Italy
Completed
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
Recruiting
Campus Bio Medico di Roma
Roma, Italy
Recruiting
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy
Recruiting
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Completed
Ospedale Cardinale G. Panico
Tricase, Italy
Completed
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, Italy
Recruiting
VU Medisch Centrum
Amsterdam, Netherlands
Completed
UMCG
Groningen, Netherlands
Completed
Ulstmad - Hosp. Chaves
Chaves, Portugal
Recruiting
Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, Portugal
Recruiting
Uls Sao Joao - Hosp. Sao Joao
Porto, Portugal
Recruiting
Showing 60 of 90 sites — filter to narrow it down. 47 of the 90 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05160584. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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