A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment

Last updated: March 28, 2025
Sponsor: Janssen-Cilag Ltd.
Overall Status: Completed

Phase

N/A

Condition

Cancer

Multiple Myeloma

Lymphoproliferative Disorders

Treatment

No intervention

Clinical Study ID

NCT04035226
CR108651
68284528MMY4001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response)

  • Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible

  • 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

Study Design

Total Participants: 254
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
August 02, 2019
Estimated Completion Date:
October 27, 2022

Connect with a study center

  • Grand Hopital de Charleroi, site Notre Dame

    Charleroi, 6000
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi, site Notre Dame

    Charleroi, 6000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • Az Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Ucl de Mont-Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Vejle Hospital

    Vejle, 7100
    Denmark

    Site Not Available

  • Centre Hospitalier du Mans

    Le Mans, 72000
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille Cedex, 59000
    France

    Site Not Available

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295
    France

    Site Not Available

  • CHU de Montpellier, Hopital Saint-Eloi

    Montpellier, 34295
    France

    Site Not Available

  • C.H.U. Hotel Dieu - France

    Nantes, 44093
    France

    Site Not Available

  • Hopital Saint-Antoine

    PARIS cedex 12, 75571
    France

    Site Not Available

  • Hopital Saint Louis

    Paris cedex 10, 75475
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris cedex 10, 75475
    France

    Site Not Available

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac cedex, 33604
    France

    Site Not Available

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021
    France

    Site Not Available

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, 86021
    France

    Site Not Available

  • Hopital Pontchaillou Service d'hematologie

    Rennes Cedex, 35033
    France

    Site Not Available

  • Pôle IUC Oncopole CHU

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

    Hamburg, 20251
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Koeln, 50397
    Germany

    Site Not Available

  • Universitaetsklinikum Koelnt

    Koeln, 50397
    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

    Site Not Available

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

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitatsklinikum Wurzburg

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97080
    Germany

    Site Not Available

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124
    Italy

    Site Not Available

  • U.O. Ematologia con Trapianto- AOU Policlinico di Bari

    Bari, 70124
    Italy

    Site Not Available

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

    Bologna, 40138
    Italy

    Site Not Available

  • Policlinico di Catania

    Catania, 95128
    Italy

    Site Not Available

  • AO Cosenza

    Cosenza, 87100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliera San Martino - IST

    Genova, 16132
    Italy

    Site Not Available

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

    Meldola, 47014
    Italy

    Site Not Available

  • 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

    Site Not Available

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Irccs Crob

    Rionero in Vulture, 85028
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Università di Roma La Sapienza

    Roma, 00161
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168
    Italy

    Site Not Available

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Ospedale Cardinale G. Panico

    Tricase, 73039
    Italy

    Site Not Available

  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

    Turin, 10126
    Italy

    Site Not Available

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • UMCG

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Erasmus MC - Satellite

    Rotterdam, 3075 EA
    Netherlands

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500
    Poland

    Site Not Available

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, 20-081
    Poland

    Site Not Available

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan, 60-569
    Poland

    Site Not Available

  • Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

    Poznan, 60 569
    Poland

    Site Not Available

  • Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • City Clinical Hospital # 40

    Moscow, 129301
    Russian Federation

    Site Not Available

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Novosibirsk State Medical University

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • Samara Region Clinical Hospital

    Samara, 443095
    Russian Federation

    Site Not Available

  • Clinical Research Institute of Hematology and Transfusiology

    St-Petersburg, 191024
    Russian Federation

    Site Not Available

  • Hosp. Clinic I Provincial De Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908
    Spain

    Site Not Available

  • Hosp. Puerta Del Mar

    Cadiz, 11009
    Spain

    Site Not Available

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407
    Spain

    Site Not Available

  • Hosp. de Leon

    Leon, 24008
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hosp. Univ. Son Espases

    Palma, 7120
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hosp. Mutua Terrassa

    Terrassa, 08221
    Spain

    Site Not Available

  • Hosp. Univ. Dr. Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

  • Karolinska University Hospital

    Stockholm, SE-141 86
    Sweden

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • University Hospital Birmingham (QE)

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Maidstone Hospital

    Kent, ME16 9QQ
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary - Haematology

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, SW17 OQT
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT
    United Kingdom

    Site Not Available

  • Oncology Institute of Hope and Innovation

    Tucson, Arizona 85745
    United States

    Site Not Available

  • Oncology Institute of Hope and Innovation

    Corona, California 92882
    United States

    Site Not Available

  • Oncology Institute of Hope and Innovation

    Glendale, California 91204
    United States

    Site Not Available

  • Marin Cancer Center

    Greenbrae, California 94904
    United States

    Site Not Available

  • Asclepes Research

    Weeki Wachee, Florida 34607
    United States

    Site Not Available

  • Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Touro Infirmary

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Providence Cancer Center

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Central Care Cancer Center

    Bolivar, Missouri 65613
    United States

    Site Not Available

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Optum Care

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Hunterdon Hematology Oncology

    Flemington, New Jersey 08822
    United States

    Site Not Available

  • Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • The Cancer Institute at St. Francis Hospital

    East Hills, New York 11548
    United States

    Site Not Available

  • North Shore Hematology Oncology Associates, P.C.

    East Setauket, New York 11733
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

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