Actively Recruiting

Age: 18Years +
All Genders
ID05160584

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

On this page

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

Eligible

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
Not Eligible

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

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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

Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1

Cluj-Napoca, Romania, 400015

Actively Recruiting

63

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, Spain, 08908

Completed

64

Hosp. de Cabuenes

Gijón, Spain, 33394

Actively Recruiting

65

Hosp. Univ. Virgen de Las Nieves

Granada, Spain, 18014

Actively Recruiting

66

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain, 11407

Completed

67

Hosp. de Leon

León, Spain, 24008

Actively Recruiting

68

Hosp. Univ. Ramon Y Cajal

Madrid, Spain, 28034

Completed

69

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Completed

70

Hosp. Univ. Son Espases

Palma, Spain, 7120

Actively Recruiting

71

Clinica Univ. de Navarra

Pamplona, Spain, 31008

Completed

72

Hosp Clinico Univ de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

73

Hosp. Univ. Marques de Valdecilla

Santander, Spain, 39008

Actively Recruiting

74

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain, 15706

Completed

75

Hosp. Clinico Univ. de Valencia

Valencia, Spain, 46010

Actively Recruiting

76

Hosp. Univ. Dr. Peset

Valencia, Spain, 46017

Actively Recruiting

77

Hosp. Clinico Univ. de Valladolid

Valladolid, Spain, 47003

Completed

78

Hosp. Univ. Miguel Servet

Zaragoza, Spain, 50009

Actively Recruiting

79

Kantonsspital Graubunden

Chur, Switzerland, 7000

Actively Recruiting

80

Kantonsspital Winterthur, Medizinische Onkologie

Winterthur, Switzerland, 8400

Actively Recruiting

81

Hirslanden Klinik Hirslanden

Zurich, Switzerland, 8032

Actively Recruiting

82

Universitatsspital Zurich

Zurich, Switzerland, 8091

Actively Recruiting

83

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Completed

84

University College Hospital

London, United Kingdom, NW1 2PG

Completed

85

Kings College Hospital

London, United Kingdom, SE5 9RS

Completed

86

St Georges Hospital

London, United Kingdom, SW17 OQT

Completed

87

Maidstone Hospital

Maidstone, United Kingdom, ME16 9QQ

Completed

88

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG5 1PB

Completed

89

The Royal Marsden NHS Trust Sutton

Surrey, United Kingdom, SM2 5PT

Completed

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Research Team

S

Study Contact

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent.

Hermann Einsele, Philippe Moreau, Nizar Bahlis...

https://pubmed.ncbi.nlm.nih.gov/41313549

Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma.

Hermann Einsele, Philippe Moreau, Nizar Bahlis...

https://pubmed.ncbi.nlm.nih.gov/38402374

Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma.

Philippe Moreau, María-Victoria Mateos, Maria Esther Gonzalez Garcia...

https://pubmed.ncbi.nlm.nih.gov/38110653