A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
Led by Janssen Pharmaceutica N.V., Belgium · Updated on 2026-06-05
300
Participants Needed
89
Research Sites
13 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
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Frequently Asked Questions
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in people with relapsed and/or refractory multiple myeloma over a 24-month period. This observational study focuses on participants who have previously received treatment and aims to understand real-life clinical practice outcomes. The study is sponsored by Janssen Pharmaceutica N.V., Belgium, and collects data from routine medical care without interventional treatments.
Participants with relapsed/refractory multiple myeloma receiving standard antimyeloma treatments as part of their regular clinical care will be observed. The primary source of data will be the participants' medical records. There is no experimental drug or placebo involved. The study includes different observation periods to assess various outcomes related to response rates, disease progression, and quality of life.
During the study, researchers will review participants' medical records and track a wide range of outcomes including overall response rate, progression-free survival, adverse events, and health-related quality of life using validated questionnaires. The study follows participants for up to 52 months, monitoring treatment responses, safety, and patient-reported oral toxicities. This long-term observation helps to understand treatment effectiveness and patient experiences in everyday clinical settings.
CONDITIONS
Brief Title
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Have a documented diagnosis of multiple myeloma according to International Myeloma Working Group diagnostic criteria (Periods 1, 2, and 3 with specific timing and treatment distinctions)
For Periods 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1; for Period 3: ECOG grade of 0, 1, or 2
Must not be pregnant or planning pregnancy during the study period
Must sign informed consent form indicating understanding and willingness to participate
For Periods 1 and 2: Received at least 3 prior lines of therapy with at least 1 complete treatment cycle for each, unless progressive disease was best response
For Periods 1 and 2: Have documented evidence of progressive disease per IMWG criteria on or after last regimen or be refractory/non-responsive within previous 6 months
For Periods 1 and 2: Measurable disease at screening as defined by specific serum or urine monoclonal protein levels or light chain criteria
For Period 1: Prior therapy includes a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
For Period 2: Prior therapy includes proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, and BCMA-targeted therapy
For Period 3: Measurable disease at screening or presence of bone lesions or plasmacytomas meeting defined criteria
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 52 months
Participants with relapsed/refractory multiple myeloma receiving antimyeloma treatment as standard of care under routine clinical practice are observed.
Visits as per routine clinical practice for up to 52 months
Trial Site Locations
Total: 89 locations
1
LKH Leoben
Leoben, Austria, 8700
Actively Recruiting
2
Krankenhaus der barmherzigen Schwestern
Vienna, Austria, 1060
Actively Recruiting
3
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
4
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
5
UZ Leuven
Leuven, Belgium, 3000
Completed
6
Chu Helora Hospital De Mons Site Kennedy
Mons, Belgium, 7000
Actively Recruiting
7
Vitaz
Sint-Niklaas, Belgium, 9100
Actively Recruiting
8
Ucl de Mont-Godinne
Yvoir, Belgium, 5530
Completed
9
CHRU de Lille Hopital Claude Huriez
Lille, France, 59037
Completed
10
CHU de Montpellier Hopital Saint Eloi
Montpellier, France, 34295
Completed
11
CHU de Nantes hotel Dieu
Nantes, France, 44093
Completed
12
Centre hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
Completed
13
Pôle IUC Oncopole CHU
Toulouse, France, 31059
Completed
14
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berin, Germany, 12203
Completed
15
Universitaetsklinikum Koeln
Cologne, Germany, 50397
Completed
16
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
Dresden, Germany, 01307
Completed
17
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
Hamburg, Germany, 20251
Completed
18
St. Barbara-Klinik Hamm GmbH
Hamm, Germany, 59073
Completed
19
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Completed
20
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
Completed
21
MVZ Mitte-Onkologische Schwerpunktpraxis
Leipzig, Germany, 04103
Completed
22
Universitaetsklinikum Leipzig
Leipzig, Germany, 4103
Completed
23
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tübingen, Germany, 72076
Completed
24
Universitatsklinikum Wurzburg
Würzburg, Germany, 97080
Completed
25
Heinrich-Braun-Klinikum gGmbH
Zwickau, Germany, 08060
Completed
26
University Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
Actively Recruiting
27
Henry Dunant Hospital Center
Athens, Greece, 115 26
Actively Recruiting
28
Laiko General Hospital Of Athens 1
Athens, Greece, 115 27
Actively Recruiting
29
Laiko General Hospital of Athens 2
Athens, Greece, 115 27
Actively Recruiting
30
Alexandra Hospital
Athens, Greece, 115 28
Actively Recruiting
31
Metaxa Cancer Center Hospital Of Piraeus
Piraeus, Greece, 18537
Actively Recruiting
32
General University Hospital of Patras
Rio, Greece, 265 04
Actively Recruiting
33
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, Greece, 546 39
Actively Recruiting
34
Ahepa University General Hospital of Thessaloniki
Thessaloniki, Greece, 54636
Actively Recruiting
35
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Completed
36
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
37
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
38
Policlinico di Catania
Catania, Italy, 95128
Completed
39
Ospedale Civile di Civitanova Marche
Civitanova Marche, Italy, 62012
Actively Recruiting
40
IRCCS Azienda Ospedaliera San Martino - IST
Genova, Italy, 16132
Completed
41
Ospedale Policlinico San Martino IRCCS
Genova, Italy, 16132
Actively Recruiting
42
Ospedale Vito Fazzi
Lecce, Italy, 73100
Actively Recruiting
43
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy, 47014
Completed
44
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, Italy, 35128
Completed
45
Ospedale Villa Sofia-Cervello
Palermo, Italy, 90146
Actively Recruiting
46
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
47
Presidio Ospedaliero Pescara
Pescara, Italy, 65124
Actively Recruiting
48
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, Italy, 89124
Actively Recruiting
49
Università di Roma La Sapienza
Roma, Italy, 00161
Completed
50
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
51
Campus Bio Medico di Roma
Roma, Italy, 128
Actively Recruiting
52
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy, 71013
Actively Recruiting
53
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy, 71013
Completed
54
Ospedale Cardinale G. Panico
Tricase, Italy, 73039
Completed
55
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, Italy, 36100
Actively Recruiting
56
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Completed
57
UMCG
Groningen, Netherlands, 9713 GZ
Completed
58
Ulstmad - Hosp. Chaves
Chaves, Portugal, 5400 482
Actively Recruiting
59
Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, Portugal, 3004 561
Actively Recruiting
60
Uls Sao Joao - Hosp. Sao Joao
Porto, Portugal, 4200 319
Actively Recruiting
61
Fundeni Clinical Institute
Bucharest, Romania, 022328
Actively Recruiting
62
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