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
Completed
Conditions studied: Multiple Myeloma
In brief
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).
Key facts
- Study ID
- NCT04035226
- Run by
- Janssen-Cilag Ltd.
- People needed
- 254
- Starts
- 2019-08-02
- Expected to finish
- 2022-10-27
- Last updated by the study team
- 2025-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Pôle IUC Oncopole CHU — Toulouse, France
- Universitaetsklinikum Koelnt — Cologne, Germany
- Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik — Hamburg, Germany
- Universitaetsklinikum Heidelberg — Heidelberg, Germany
- Medizinische Klinik A — Münster, Germany
- Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany — Tübingen, Germany
- Universitatsklinikum Wurzburg — Würzburg, Germany
- U.O. Ematologia con Trapianto- AOU Policlinico di Bari — Bari, Italy
- U.O. Ematologia Istituto Tumori Giovanni Paolo II — Bari, Italy
- Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi — Bologna, Italy
- Policlinico di Catania — Catania, Italy
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy
- IRCCS Azienda Ospedaliera San Martino - IST — Genova, Italy
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Italy
- Universita degli Studi di Padova Azienda Ospedaliera di Pa — Padova, Italy
- Ospedale Villa Sofia-Cervello — Palermo, Italy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
- Irccs Crob — Rionero in Vulture, Italy
- Università di Roma La Sapienza — Roma, Italy
- Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy
- IRCCS Ospedale Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy
- Ospedale Cardinale G. Panico — Tricase, Italy
- A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette — Turin, Italy
- VU Medisch Centrum — Amsterdam, Netherlands
- CHU Poitiers - Hopital la Miletrie — Poitiers, France
Full record on ClinicalTrials.gov
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