Tests a treatment break in newly diagnosed multiple myeloma
Compares continuous daratumumab, lenalidomide and dexamethasone with a treatment-free interval in myeloma.
Plain-language title generated from the registry record
Registry title: FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)
Key facts
- Where
- 's-Gravenhage, 's-Hertogenbosch, Alkmaar, Almelo, Almere, Amersfoort, Amstelveen, Amsterdam, Apeldoorn, Arnhem, Assen, Beugen, Beverwijk, Breda, Capelle aan den IJssel, Delft, Deventer, Dirksland, Doetinchem, Dordrecht, Drachten, Ede Gld, Eindhoven, Emmen, Enschede, Geldrop, Geleen, Goes, Gorinchem, Gouda, Groningen, Hardenberg, Harderwijk, Heerenveen, Helmond, Hilversum, Hoofddorp, Hoorn Nh, Leeuwarden, Leiderdorp, Maastricht, Nieuwegein, Nijmegen, Roermond, Roosendaal, Rotterdam, Scheemda, Schiedam, Sneek, Terneuzen, Tiel, Tilburg, Uden, Utrecht, Venlo, Zaandam, and Zwolle, NetherlandsSee the 64 sites
- Phase
- Phase 3
Where in Netherlands
- St. Jans GasthuisNetherlandsTaking people
- Haga Hospital's-Gravenhage, NetherlandsTaking people
- Medical Center Haaglanden's-Gravenhage, NetherlandsTaking people
- Jeroen Bosch Ziekenhuis's-Hertogenbosch, NetherlandsTaking people
- Noordwest Ziekenhuisgroep StichtingAlkmaar, NetherlandsTaking people
- Ziekenhuisgroep Twente StichtingAlmelo, NetherlandsTaking people
- Flevoziekenhuis StichtingAlmere, NetherlandsTaking people
- Meander Medisch CentrumAmersfoort, NetherlandsTaking people
- Ziekenhuis AmstellandAmstelveen, NetherlandsTaking people
- Amsterdam UMCAmsterdam, NetherlandsTaking people
- Stichting OLVGAmsterdam, NetherlandsTaking people
- Gelre HospitalsApeldoorn, NetherlandsTaking people
- Rijnstate Ziekenhuis StichtingArnhem, NetherlandsTaking people
- Wilhelmina Ziekenhuis AssenAssen, NetherlandsTaking people
- Maasziekenhuis Pantein B.V.Beugen, NetherlandsTaking people
- Rode Kruis Ziekenhuis B.V.Beverwijk, NetherlandsTaking people
- Amphia HospitalBreda, NetherlandsTaking people
- IJsselland ZiekenhuisCapelle aan den IJssel, NetherlandsTaking people
- Reinier de Graaf GroepDelft, NetherlandsTaking people
- Deventer ZiekenhuisDeventer, NetherlandsTaking people
- Het Van Weel-Bethesda ZiekenhuisDirksland, NetherlandsTaking people
- Slingeland ZiekenhuisDoetinchem, NetherlandsTaking people
- Albert Schweitzer ZiekenhuisDordrecht, NetherlandsTaking people
- Ziekenhuis Nij SmellingheDrachten, NetherlandsTaking people
- Ziekenhuis Gelderse Vallei StichtingEde Gld, NetherlandsTaking people
- Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
- Máxima Medisch CentrumEindhoven, NetherlandsTaking people
- Treant Ziekenhuiszorg StichtingEmmen, NetherlandsTaking people
- Medisch Spectrum TwenteEnschede, NetherlandsTaking people
- St. Anna ZiekenhuisGeldrop, NetherlandsTaking people
- Zuyderland Medisch Centrum StichtingGeleen, NetherlandsTaking people
- Admiraal de Ruijter ZiekenhuisGoes, NetherlandsTaking people
- Beatrix ZiekenhuisGorinchem, NetherlandsTaking people
- Groene Hart ZiekenhuisGouda, NetherlandsTaking people
- Stichting Martini ZiekenhuisGroningen, NetherlandsTaking people
- Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
- Saxenburgh Medisch CentrumHardenberg, NetherlandsTaking people
- Ziekenhuis St JansdalHarderwijk, NetherlandsTaking people
- Frisius MCHeerenveen, NetherlandsTaking people
- Elkerliek ziekenhuisHelmond, NetherlandsTaking people
- TergooiziekenhuizenHilversum, NetherlandsTaking people
- Spaarne GasthuisHoofddorp, NetherlandsTaking people
- Dijklander ZiekenhuisHoorn Nh, NetherlandsTaking people
- Frisius MCLeeuwarden, NetherlandsTaking people
- Alrijne Zorggroep StichtingLeiderdorp, NetherlandsTaking people
- University Hospital MaastrichtMaastricht, NetherlandsTaking people
- Sint Antonius Ziekenhuis StichtingNieuwegein, NetherlandsTaking people
- Canisius-Wilhelmina HospitalNijmegen, NetherlandsTaking people
- Laurentius Ziekenhuis RoermondRoermond, NetherlandsTaking people
- Bravis ZiekenhuisRoosendaal, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Ikazia ZiekenhuisRotterdam, NetherlandsTaking people
- Maasstad Ziekenhuis StichtingRotterdam, NetherlandsTaking people
- Ommelander Ziekenhuis Groningen B.V.Scheemda, NetherlandsTaking people
- Sint Franciscus Vlietland Groep StichtingSchiedam, NetherlandsTaking people
- Antonius Ziekenhuis SneekSneek, NetherlandsTaking people
- ZorgSaam ZiekenhuisTerneuzen, NetherlandsTaking people
- Ziekenhuis RivierenlandTiel, NetherlandsTaking people
- St. Elisabeth Hospital TilburgTilburg, NetherlandsTaking people
- Bernhoven B.V.Uden, NetherlandsTaking people
- Diakonessenhuis StichtingUtrecht, NetherlandsTaking people
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, NetherlandsTaking people
- Zaans Medisch Centrum StichtingZaandam, NetherlandsTaking people
- Isala Klinieken StichtingZwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Trial code
- NCT06187441EU 2023-508586-33-00
- Record updated
- 19 August 2024
- Original description
In the Netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as Dara-Rd. In many patients this treatment results in suppressing the disease for a long time. The treatment is continued until it is not effective anymore and the disease progresses.Read full original descriptionShow less
FeAsiBility of a Treatment Free Interval in Newly Diagnosed mUltiple myeLOma Patients Treated With DaratumUmab-Lenalidomide-DexamethaSone- the FABULOUS Study. A Nationwide Open-label Randomized Phase III Clinical Trial Comparing Daratumumab-lenalidomide-dexamethasone Continuously Versus Including a Treatment Free Interval
In the Netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as Dara-Rd. In many patients this treatment results in suppressing the disease for a long time. The treatment is continued until it is not effective anymore and the disease progresses.
But until now it is unknown whether continuous therapy also leads to prolonging life. In addition, there are concerns about side effects, leading to a reduced quality of life, the development of severe toxicity that remains, which hampers subsequent therapy, and high costs due to prolonged treatment.
There are indications that temporarily stopping treatment is safe, leading to fewer side effects and allows recovering from toxicity or damage due to treatment. This may improve the quality of life.
Inclusion: Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A); Age ≥ 18 years; Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and will continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed; Partial response or better after treatment with 12 cycles of Dara-Rd, without signs of biochemical progression; ANC ≥ 1.0x109/L and platelets ≥ 75x109/L; Patient is capable of giving informed consent; Written informed consent.
Exclusion: Patient with non-secretory MM at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd; Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd; Patient in whom urine M-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd; Patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone); Patient in whom continuation of treatment with Dara-Rd is deemed not feasible because of medical reasons; Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.