A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

Last updated: April 25, 2025
Sponsor: Janssen Pharmaceutica N.V., Belgium
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Leukemia

Platelet Disorders

Treatment

No intervention

Clinical Study ID

NCT05160584
CR109118
64407564MMY4001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

For Period 1, 2 and 3

  • Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria

  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

  • Must not be pregnant or must not plan to become pregnant within the study period

  • Participants must sign an informed consent form (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

  • 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

  • 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: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level .5 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

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
November 18, 2021
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • LKH Leoben

    Leoben, 8700
    Austria

    Active - Recruiting

  • Krankenhaus der barmherzigen Schwestern

    Wien, 1060
    Austria

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Completed

  • Ucl de Mont-Godinne

    Yvoir, 5530
    Belgium

    Completed

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037
    France

    Completed

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier Cedex 5, 34295
    France

    Completed

  • CHU de Montpellier, Hopital Saint-Eloi

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • CHU de Nantes hotel Dieu

    Nantes Cedex 1, 44093
    France

    Completed

  • CHU de Nantes hotel-Dieu

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • CHU de Nantes hôtel-Dieu

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Hôpital Saint Louis

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495
    France

    Completed

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers Cedex, 96021
    France

    Site Not Available

  • Pôle IUC Oncopole CHU

    Toulouse cedex 9, 31059
    France

    Completed

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berin, 12203
    Germany

    Active - Recruiting

  • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

    Hamburg, 20251
    Germany

    Active - Recruiting

  • St. Barbara-Klinik Hamm GmbH

    Hamm, 59073
    Germany

    Active - Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koeln

    Koeln, 50397
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koelnt

    Koeln, 50397
    Germany

    Site Not Available

  • MVZ Mitte-Onkologische Schwerpunktpraxis

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 4103
    Germany

    Active - Recruiting

  • Universitatsklinikum Leipzig

    Leipzig, 4103
    Germany

    Site Not Available

  • Medizinische Klinik A

    Muenster, 48149
    Germany

    Site Not Available

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

    Tubingen, 72076
    Germany

    Active - Recruiting

  • Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitatsklinikum Wurzburg

    Wuerzburg, 97080
    Germany

    Active - Recruiting

  • Universitatsklinikum Wurzburg

    Würzburg, 97080
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97080
    Germany

    Site Not Available

  • Heinrich-Braun-Klinikum gGmbH

    Zwickau, 08060
    Germany

    Active - Recruiting

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100
    Greece

    Active - Recruiting

  • Alexandra Hospital

    Athens, 115 28
    Greece

    Active - Recruiting

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39
    Greece

    Active - Recruiting

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124
    Italy

    Completed

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

    Bologna, 40138
    Italy

    Completed

  • Policlinico di Catania

    Catania, 95128
    Italy

    Completed

  • IRCCS Azienda Ospedaliera San Martino - IST

    Genova, 16132
    Italy

    Completed

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

    Meldola, 47014
    Italy

    Completed

  • Universita degli Studi di Padova - Azienda Ospedaliera di Pa

    Padova, 35128
    Italy

    Site Not Available

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    Padova, 35128
    Italy

    Completed

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146
    Italy

    Completed

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Completed

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168
    Italy

    Completed

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Università di Roma La Sapienza

    Roma, 00161
    Italy

    Completed

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168
    Italy

    Site Not Available

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Completed

  • Ospedale Cardinale G. Panico

    Tricase, 73039
    Italy

    Completed

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Completed

  • UMCG

    Groningen, 9713 GZ
    Netherlands

    Completed

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908
    Spain

    Completed

  • Hosp. de Cabuenes

    Gijón, 33394
    Spain

    Active - Recruiting

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407
    Spain

    Completed

  • Hosp. de Leon

    Leon, 24008
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 De Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Completed

  • Hosp. Univ. Son Espases

    Palma, 7120
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Completed

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Completed

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Completed

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hosp. Univ. Dr. Peset

    Valencia, 46017
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003
    Spain

    Completed

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Completed

  • King s College Hospital

    London, SE5 9RS
    United Kingdom

    Completed

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Completed

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Completed

  • St George's Hospital

    London, SW17 OQT
    United Kingdom

    Completed

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Completed

  • Maidstone Hospital

    Maidstone, ME16 9QQ
    United Kingdom

    Completed

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB
    United Kingdom

    Completed

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT
    United Kingdom

    Completed

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