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Real-World watch: how do standard treatments perform against tough myeloma?

NCT ID NCT05160584

Knowledge-focused Sponsor: Janssen Pharmaceutica N.V., Belgium Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study follows about 300 people with multiple myeloma that has come back or stopped responding to treatment. Researchers will watch how well standard treatments work in real-life settings over 24 months, focusing on response rates, safety, and how patients feel. The goal is to gather practical information, not to test a new drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \[cm\])

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ahepa University General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, 54636, Greece

  • Alexandra Hospital

    RECRUITING

    Athens, 115 28, Greece

  • Anticancer Hospital of Thessaloniki Theageneio

    RECRUITING

    Thessaloniki, 546 39, Greece

  • Azienda Ulss 8 Berica- Ospedale Di Vicenza

    RECRUITING

    Vicenza, 36100, Italy

  • 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

  • Campus Bio Medico di Roma

    RECRUITING

    Roma, 128, Italy

  • Casa Sollievo Della Sofferenza IRCCS

    RECRUITING

    San Giovanni Rotondo, 71013, Italy

  • Centre hospitalier Lyon-Sud

    COMPLETED

    Pierre-Bénite, 69495, France

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    COMPLETED

    Berin, 12203, Germany

  • Chu Helora Hospital De Mons Site Kennedy

    RECRUITING

    Mons, 7000, Belgium

  • Clinica Univ. de Navarra

    COMPLETED

    Pamplona, 31008, Spain

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, 022328, Romania

  • General University Hospital of Patras

    RECRUITING

    Rio, 265 04, Greece

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

    RECRUITING

    Reggio Calabria, 89124, Italy

  • Heinrich-Braun-Klinikum gGmbH

    COMPLETED

    Zwickau, 08060, Germany

  • Henry Dunant Hospital Center

    RECRUITING

    Athens, 115 26, Greece

  • Hirslanden Klinik Hirslanden

    RECRUITING

    Zurich, 8032, Switzerland

  • Hosp Clinico Univ de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hosp. Clinico Univ. de Santiago

    COMPLETED

    Santiago de Compostela, 15706, Spain

  • Hosp. Clinico Univ. de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hosp. Clinico Univ. de Valladolid

    COMPLETED

    Valladolid, 47003, Spain

  • Hosp. Univ. 12 de Octubre

    COMPLETED

    Madrid, 28041, Spain

  • Hosp. Univ. Dr. Peset

    RECRUITING

    Valencia, 46017, Spain

  • Hosp. Univ. Marques de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hosp. Univ. Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hosp. Univ. Ramon Y Cajal

    COMPLETED

    Madrid, 28034, Spain

  • Hosp. Univ. Son Espases

    RECRUITING

    Palma, 7120, Spain

  • Hosp. Univ. Virgen de Las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hosp. de Cabuenes

    RECRUITING

    Gijón, 33394, Spain

  • Hosp. de Jerez de La Frontera

    COMPLETED

    Jerez de la Frontera, 11407, Spain

  • Hosp. de Leon

    RECRUITING

    León, 24008, Spain

  • IRCCS Azienda Ospedaliera San Martino - IST

    COMPLETED

    Genova, 16132, Italy

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    COMPLETED

    San Giovanni Rotondo, 71013, Italy

  • Inst. Cat. Doncologia-H Duran I Reynals

    COMPLETED

    Barcelona, 08908, Spain

  • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1

    RECRUITING

    Cluj-Napoca, 400015, Romania

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    COMPLETED

    Meldola, 47014, Italy

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

    RECRUITING

    Bologna, 40138, Italy

  • Kantonsspital Graubunden

    RECRUITING

    Chur, 7000, Switzerland

  • Kantonsspital Winterthur, Medizinische Onkologie

    RECRUITING

    Winterthur, 8400, Switzerland

  • Kings College Hospital

    COMPLETED

    London, SE5 9RS, United Kingdom

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

    COMPLETED

    Tübingen, 72076, Germany

  • Krankenhaus der barmherzigen Schwestern

    RECRUITING

    Vienna, 1060, Austria

  • LKH Leoben

    RECRUITING

    Leoben, 8700, Austria

  • Laiko General Hospital Of Athens 1

    RECRUITING

    Athens, 115 27, Greece

  • Laiko General Hospital of Athens 2

    RECRUITING

    Athens, 115 27, Greece

  • MVZ Mitte-Onkologische Schwerpunktpraxis

    COMPLETED

    Leipzig, 04103, Germany

  • Maidstone Hospital

    COMPLETED

    Maidstone, ME16 9QQ, United Kingdom

  • Metaxa Cancer Center Hospital Of Piraeus

    RECRUITING

    Piraeus, 18537, Greece

  • Nottingham University Hospitals NHS Trust

    COMPLETED

    Nottingham, NG5 1PB, United Kingdom

  • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

    COMPLETED

    Bari, 70124, Italy

  • Ospedale Cardinale G. Panico

    COMPLETED

    Tricase, 73039, Italy

  • Ospedale Civile di Civitanova Marche

    RECRUITING

    Civitanova Marche, 62012, Italy

  • Ospedale Policlinico San Martino IRCCS

    RECRUITING

    Genova, 16132, Italy

  • Ospedale Villa Sofia-Cervello

    RECRUITING

    Palermo, 90146, Italy

  • Ospedale Vito Fazzi

    RECRUITING

    Lecce, 73100, Italy

  • Policlinico di Catania

    COMPLETED

    Catania, 95128, Italy

  • Presidio Ospedaliero Pescara

    RECRUITING

    Pescara, 65124, Italy

  • Pôle IUC Oncopole CHU

    COMPLETED

    Toulouse, 31059, France

  • Southmead Hospital

    COMPLETED

    Bristol, BS10 5NB, United Kingdom

  • Spitalul Clinic Coltea, Clinica Hematologie

    RECRUITING

    Bucharest, Romania

  • St Georges Hospital

    COMPLETED

    London, SW17 OQT, United Kingdom

  • St. Barbara-Klinik Hamm GmbH

    COMPLETED

    Hamm, 59073, Germany

  • Staedtisches Klinikum Karlsruhe gGmbH

    COMPLETED

    Karlsruhe, Germany

  • The Royal Marsden NHS Trust Sutton

    COMPLETED

    Surrey, SM2 5PT, United Kingdom

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    RECRUITING

    Bari, 70124, Italy

  • UMCG

    COMPLETED

    Groningen, 9713 GZ, Netherlands

  • UZ Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • UZ Leuven

    COMPLETED

    Leuven, 3000, Belgium

  • Ucl de Mont-Godinne

    COMPLETED

    Yvoir, 5530, Belgium

  • Uls Coimbra - Hosp. Univ. Coimbra

    RECRUITING

    Coimbra, 3004 561, Portugal

  • Uls Sao Joao - Hosp. Sao Joao

    RECRUITING

    Porto, 4200 319, Portugal

  • Ulstmad - Hosp. Chaves

    RECRUITING

    Chaves, 5400 482, Portugal

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    COMPLETED

    Padova, 35128, Italy

  • Universitaetsklinikum Heidelberg

    COMPLETED

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln

    COMPLETED

    Cologne, 50397, Germany

  • Universitaetsklinikum Leipzig

    COMPLETED

    Leipzig, 4103, Germany

  • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

    COMPLETED

    Dresden, 01307, Germany

  • Universitatsklinikum Wurzburg

    COMPLETED

    Würzburg, 97080, Germany

  • Universitatsspital Zurich

    RECRUITING

    Zurich, 8091, Switzerland

  • University College Hospital

    COMPLETED

    London, NW1 2PG, United Kingdom

  • University Hospital of Alexandroupolis

    RECRUITING

    Alexandroupoli, 68100, Greece

  • Università di Roma La Sapienza

    COMPLETED

    Roma, 00161, Italy

  • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

    COMPLETED

    Hamburg, 20251, Germany

  • VU Medisch Centrum

    COMPLETED

    Amsterdam, 1081 HV, Netherlands

  • Vitaz

    RECRUITING

    Sint-Niklaas, 9100, Belgium

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, 3600, Belgium

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