A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Recruiting now
Conditions studied: Relapsed/Refractory Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT05160584
- Run by
- Janssen Pharmaceutica N.V., Belgium
- People needed
- 300
- Starts
- 2021-11-18
- Expected to finish
- 2028-10-30
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
- For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
- For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
- For Period 1,2 and 3: Participants must sign an 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
- For Period 1 and 2: 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
- For Period 1 and 2: 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: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain >= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (>=1 lesion has 2 diameters >= 1 centimeter [cm])
Where it is running
- Ospedale Civile di Civitanova Marche — Civitanova Marche, Italy (enrolling)
- Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria — Reggio Calabria, Italy (enrolling)
- Alexandra Hospital — Athens, Greece (enrolling)
- Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi — Bologna, Italy (enrolling)
- Ospedale Villa Sofia-Cervello — Palermo, Italy (enrolling)
- Presidio Ospedaliero Pescara — Pescara, Italy (enrolling)
- Henry Dunant Hospital Center — Athens, Greece (enrolling)
- Laiko General Hospital of Athens 2 — Athens, Greece (enrolling)
- General University Hospital of Patras — Rio, Greece (enrolling)
- U.O. Ematologia Istituto Tumori Giovanni Paolo II — Bari, Italy (enrolling)
- Ospedale Vito Fazzi — Lecce, Italy (enrolling)
- UZ Antwerpen — Edegem, Belgium (enrolling)
- Vitaz — Sint-Niklaas, Belgium (enrolling)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (enrolling)
- Ziekenhuis Oost-Limburg — Genk, Belgium (enrolling)
- University Hospital of Alexandroupolis — Alexandroupoli, Greece (enrolling)
- LKH Leoben — Leoben, Austria (enrolling)
- Laiko General Hospital Of Athens 1 — Athens, Greece (enrolling)
- Krankenhaus der barmherzigen Schwestern — Vienna, Austria (enrolling)
- Metaxa Cancer Center Hospital Of Piraeus — Piraeus, Greece (enrolling)
- Anticancer Hospital of Thessaloniki Theageneio — Thessaloniki, Greece (enrolling)
- Ahepa University General Hospital of Thessaloniki — Thessaloniki, Greece (enrolling)
- Chu Helora Hospital De Mons Site Kennedy — Mons, Belgium (enrolling)
- Ospedale Policlinico San Martino IRCCS — Genova, Italy (enrolling)
- Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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