NCT05160584Recruiting
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
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.
Inclusion criteria
• 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 \[cm\])
Exclusion criteria
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland, France, Germany, Italy, Austria, Belgium, Greece, Netherlands, Portugal, Romania, Spain, United Kingdom
- Sponsor
- Janssen Pharmaceutica N.V., Belgium(Industry)
- Protocol no.
- CR109118
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- Other
Treatments studied
- No intervention
Locations · 47
- Chur, SwitzerlandKantonsspital GraubundenRecruiting at this site
- Winterthur, SwitzerlandKantonsspital Winterthur, Medizinische OnkologieRecruiting at this site
- Zurich, SwitzerlandHirslanden Klinik HirslandenRecruiting at this site
- Zurich, SwitzerlandUniversitatsspital ZurichRecruiting at this site
- Bari, ItalyU.O. Ematologia Istituto Tumori Giovanni Paolo IIRecruiting at this site
- Bologna, ItalyIstituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-MalpighiRecruiting at this site
- Civitanova Marche, ItalyOspedale Civile di Civitanova MarcheRecruiting at this site
- Genova, ItalyOspedale Policlinico San Martino IRCCSRecruiting at this site
- Lecce, ItalyOspedale Vito FazziRecruiting at this site
- Palermo, ItalyOspedale Villa Sofia-CervelloRecruiting at this site
- Pavia, ItalyFondazione IRCCS Policlinico San MatteoRecruiting at this site
- Pescara, ItalyPresidio Ospedaliero PescaraRecruiting at this site
- Reggio Calabria, ItalyGrande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio CalabriaRecruiting at this site
- Roma, ItalyFondazione Policlinico Universitario A Gemelli IRCCSRecruiting at this site
- Roma, ItalyCampus Bio Medico di RomaRecruiting at this site
- San Giovanni Rotondo, ItalyCasa Sollievo Della Sofferenza IRCCSRecruiting at this site
- Vicenza, ItalyAzienda Ulss 8 Berica- Ospedale Di VicenzaRecruiting at this site
- Leoben, AustriaLKH LeobenRecruiting at this site
- Vienna, AustriaKrankenhaus der barmherzigen SchwesternRecruiting at this site
- Edegem, BelgiumUZ AntwerpenRecruiting at this site
- Genk, BelgiumZiekenhuis Oost-LimburgRecruiting at this site
- Mons, BelgiumChu Helora Hospital De Mons Site KennedyRecruiting at this site
- Sint-Niklaas, BelgiumVitazRecruiting at this site
- Alexandroupoli, GreeceUniversity Hospital of AlexandroupolisRecruiting at this site
- Athens, GreeceHenry Dunant Hospital CenterRecruiting at this site
- Athens, GreeceLaiko General Hospital Of Athens 1Recruiting at this site
- Athens, GreeceLaiko General Hospital of Athens 2Recruiting at this site
- Athens, GreeceAlexandra HospitalRecruiting at this site
- Piraeus, GreeceMetaxa Cancer Center Hospital Of PiraeusRecruiting at this site
- Rio, GreeceGeneral University Hospital of PatrasRecruiting at this site
In total, worldwide, 47 of the 90 sites listed in the registry are recruiting; the other 43 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 25, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 17 more locations
Other identifiers
- 64407564MMY4001 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.