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

Study Purpose

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 (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.
  • - 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.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05160584
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Pharmaceutica N.V., Belgium
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Pharmaceutica N.V., Belgium Clinical Trial
Principal Investigator Affiliation Janssen Pharmaceutica N.V., Belgium
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/Refractory Multiple Myeloma
Arms & Interventions

Arms

: Participants with Relapsed/Refractory Multiple Myeloma

Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.

Interventions

Other: - No intervention

There is no interventional treatment component for participants with RRMM in this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Ucl de Mont-Godinne, Yvoir, Belgium

Status

Recruiting

Address

Ucl de Mont-Godinne

Yvoir, , 5530

CHRU de Lille - Hôpital Claude Huriez, Lille, France

Status

Recruiting

Address

CHRU de Lille - Hôpital Claude Huriez

Lille, , 59037

CHU de Montpellier, Hopital Saint-Eloi, Montpellier Cedex 5, France

Status

Recruiting

Address

CHU de Montpellier, Hopital Saint-Eloi

Montpellier Cedex 5, , 34295

CHU de Nantes hôtel-Dieu, Nantes Cedex 1, France

Status

Recruiting

Address

CHU de Nantes hôtel-Dieu

Nantes Cedex 1, , 44093

Hôpital Saint Louis, Paris Cedex 10, France

Status

Not yet recruiting

Address

Hôpital Saint Louis

Paris Cedex 10, , 75475

Centre hospitalier Lyon-Sud, Pierre-Bénite, France

Status

Recruiting

Address

Centre hospitalier Lyon-Sud

Pierre-Bénite, , 69495

CHU Poitiers - Hôpital la Milétrie, Poitiers Cedex, France

Status

Not yet recruiting

Address

CHU Poitiers - Hôpital la Milétrie

Poitiers Cedex, , 96021

Pôle IUC Oncopole CHU, Toulouse cedex 9, France

Status

Recruiting

Address

Pôle IUC Oncopole CHU

Toulouse cedex 9, , 31059

Berin, Germany

Status

Not yet recruiting

Address

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berin, , 12203

Dresden, Germany

Status

Recruiting

Address

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

Dresden, , 01307

Hamburg, Germany

Status

Recruiting

Address

Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

Hamburg, , 20251

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitaetsklinikum Heidelberg

Heidelberg, , 69120

Universitaetsklinikum Koeln, Koeln, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Koeln

Koeln, , 50397

Universitatsklinikum Leipzig, Leipzig, Germany

Status

Recruiting

Address

Universitatsklinikum Leipzig

Leipzig, , 4103

Medizinische Klinik A, Muenster, Germany

Status

Withdrawn

Address

Medizinische Klinik A

Muenster, , 48149

Tübingen, Germany

Status

Recruiting

Address

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

Tübingen, , 72076

Universitätsklinikum Würzburg, Würzburg, Germany

Status

Recruiting

Address

Universitätsklinikum Würzburg

Würzburg, , 97080

Bari, Italy

Status

Recruiting

Address

U.O. Ematologia Istituto Tumori Giovanni Paolo II

Bari, , 70124

Bologna, Italy

Status

Recruiting

Address

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

Bologna, , 40138

Policlinico di Catania, Catania, Italy

Status

Recruiting

Address

Policlinico di Catania

Catania, , 95128

Genova, Italy

Status

Recruiting

Address

IRCCS Azienda Ospedaliera San Martino - IST

Genova, , 16132

Meldola, Italy

Status

Recruiting

Address

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , 47014

Padova, Italy

Status

Not yet recruiting

Address

Universita degli Studi di Padova - Azienda Ospedaliera di Pa

Padova, , 35128

Ospedale Villa Sofia-Cervello, Palermo, Italy

Status

Recruiting

Address

Ospedale Villa Sofia-Cervello

Palermo, , 90146

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Status

Recruiting

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, , 27100

Università di Roma La Sapienza, Roma, Italy

Status

Recruiting

Address

Università di Roma La Sapienza

Roma, , 00161

Rome, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , 00168

San Giovanni Rotondo, Italy

Status

Recruiting

Address

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , 71013

Ospedale Cardinale G. Panico, Tricase, Italy

Status

Recruiting

Address

Ospedale Cardinale G. Panico

Tricase, , 73039

VU Medisch Centrum, Amsterdam, Netherlands

Status

Recruiting

Address

VU Medisch Centrum

Amsterdam, , 1081 HV

UMCG, Groningen, Netherlands

Status

Recruiting

Address

UMCG

Groningen, , 9713 GZ

Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, Spain

Status

Recruiting

Address

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, , 08908

Hosp. de Cabuenes, Gijón, Spain

Status

Recruiting

Address

Hosp. de Cabuenes

Gijón, , 33394

Hosp. de Jerez de La Frontera, Jerez de la Frontera, Spain

Status

Recruiting

Address

Hosp. de Jerez de La Frontera

Jerez de la Frontera, , 11407

Hosp. de Leon, Leon, Spain

Status

Recruiting

Address

Hosp. de Leon

Leon, , 24080

Hosp. Univ. Ramon Y Cajal, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Ramon Y Cajal

Madrid, , 28034

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Univ. Son Espases, Palma, Spain

Status

Recruiting

Address

Hosp. Univ. Son Espases

Palma, , 7120

Clinica Univ. de Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Univ. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007

Hosp. Univ. Marques de Valdecilla, Santander, Spain

Status

Recruiting

Address

Hosp. Univ. Marques de Valdecilla

Santander, , 39008

Hosp. Clinico Univ. de Santiago, Santiago de Compostela, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , 15706

Hosp. Clinico Univ. de Valladolid, Valladolid, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Valladolid

Valladolid, , 47003

Southmead Hospital, Bristol, United Kingdom

Status

Recruiting

Address

Southmead Hospital

Bristol, , BS10 5NB

University College Hospital, London, United Kingdom

Status

Recruiting

Address

University College Hospital

London, , NW1 2PG

King's College Hospital, London, United Kingdom

Status

Recruiting

Address

King's College Hospital

London, , SE5 9RS

St George's Hospital, London, United Kingdom

Status

Recruiting

Address

St George's Hospital

London, , SW17 OQT

Maidstone Hospital, Maidstone, United Kingdom

Status

Recruiting

Address

Maidstone Hospital

Maidstone, , ME16 9QQ

Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospitals NHS Trust

Nottingham, , NG5 1PB

The Royal Marsden NHS Trust Sutton, Surrey, United Kingdom

Status

Recruiting

Address

The Royal Marsden NHS Trust Sutton

Surrey, , SM2 5PT