NCT06187441RecruitingPhase 3
FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 599 (estimated)
- First submitted
- 1 Dec 2023
- Start date
- 14 May 2024
- Primary completion date
- 31 Jan 2031
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Diseases
- Multiple myeloma
- NCT number
- NCT06187441
- EU CT number
- 2023-508586-33-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 599
- From 14 May 2024 to the primary completion date, 31 Jan 2031
- 64 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Stichting Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Recruiting |
| Ziekenhuisgroep Twente Stichting Coordinator of this site? Confirm its status | Almelo | Netherlands | Recruiting |
| Flevoziekenhuis Stichting Coordinator of this site? Confirm its status | Almere | Netherlands | Recruiting |
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Recruiting |
| Ziekenhuis Amstelland Coordinator of this site? Confirm its status | Amstelveen | Netherlands | Recruiting |
| Stichting OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Gelre Hospitals Coordinator of this site? Confirm its status | Apeldoorn | Netherlands | Recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Wilhelmina Ziekenhuis Assen Coordinator of this site? Confirm its status | Assen | Netherlands | Recruiting |
| Maasziekenhuis Pantein B.V. Coordinator of this site? Confirm its status | Beugen | Netherlands | Recruiting |
| Rode Kruis Ziekenhuis B.V. Coordinator of this site? Confirm its status | Beverwijk | Netherlands | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| IJsselland Ziekenhuis Coordinator of this site? Confirm its status | Capelle aan den IJssel | Netherlands | Recruiting |
| Reinier de Graaf Groep Coordinator of this site? Confirm its status | Delft | Netherlands | Recruiting |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Recruiting |
| Het Van Weel-Bethesda Ziekenhuis Coordinator of this site? Confirm its status | Dirksland | Netherlands | Recruiting |
| Slingeland Ziekenhuis Coordinator of this site? Confirm its status | Doetinchem | Netherlands | Recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Recruiting |
| Ziekenhuis Nij Smellinghe Coordinator of this site? Confirm its status | Drachten | Netherlands | Recruiting |
| Ziekenhuis Gelderse Vallei Stichting Coordinator of this site? Confirm its status | Ede Gld | Netherlands | Recruiting |
| Máxima Medisch Centrum Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Treant Ziekenhuiszorg Stichting Coordinator of this site? Confirm its status | Emmen | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| St. Anna Ziekenhuis Coordinator of this site? Confirm its status | Geldrop | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Geleen | Netherlands | Recruiting |
| Admiraal de Ruijter Ziekenhuis Coordinator of this site? Confirm its status | Goes | Netherlands | Recruiting |
| Beatrix Ziekenhuis Coordinator of this site? Confirm its status | Gorinchem | Netherlands | Recruiting |
| Groene Hart Ziekenhuis Coordinator of this site? Confirm its status | Gouda | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Stichting Martini Ziekenhuis Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Saxenburgh Medisch Centrum Coordinator of this site? Confirm its status | Hardenberg | Netherlands | Recruiting |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Recruiting |
| Frisius MC Coordinator of this site? Confirm its status | Heerenveen | Netherlands | Recruiting |
| Elkerliek ziekenhuis Coordinator of this site? Confirm its status | Helmond | Netherlands | Recruiting |
| Tergooiziekenhuizen Coordinator of this site? Confirm its status | Hilversum | Netherlands | Recruiting |
| Spaarne Gasthuis Coordinator of this site? Confirm its status | Hoofddorp | Netherlands | Recruiting |
| Dijklander Ziekenhuis Coordinator of this site? Confirm its status | Hoorn Nh | Netherlands | Recruiting |
| Frisius MC Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Alrijne Zorggroep Stichting Coordinator of this site? Confirm its status | Leiderdorp | Netherlands | Recruiting |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Stichting Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Canisius-Wilhelmina Hospital Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Laurentius Ziekenhuis Roermond Coordinator of this site? Confirm its status | Roermond | Netherlands | Recruiting |
| Bravis Ziekenhuis Coordinator of this site? Confirm its status | Roosendaal | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Ikazia Ziekenhuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Maasstad Ziekenhuis Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Ommelander Ziekenhuis Groningen B.V. Coordinator of this site? Confirm its status | Scheemda | Netherlands | Recruiting |
| Sint Franciscus Vlietland Groep Stichting Coordinator of this site? Confirm its status | Schiedam | Netherlands | Recruiting |
| Medical Center Haaglanden Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Recruiting |
| Haga Hospital Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Recruiting |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Recruiting |
| Antonius Ziekenhuis Sneek Coordinator of this site? Confirm its status | Sneek | Netherlands | Recruiting |
| ZorgSaam Ziekenhuis Coordinator of this site? Confirm its status | Terneuzen | Netherlands | Recruiting |
| Ziekenhuis Rivierenland Coordinator of this site? Confirm its status | Tiel | Netherlands | Recruiting |
| St. Elisabeth Hospital Tilburg Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Bernhoven B.V. Coordinator of this site? Confirm its status | Uden | Netherlands | Recruiting |
| Diakonessenhuis Stichting Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Stichting Viecuri Medisch Centrum voor Noord-Limburg Coordinator of this site? Confirm its status | Venlo | Netherlands | Recruiting |
| Zaans Medisch Centrum Stichting Coordinator of this site? Confirm its status | Zaandam | Netherlands | Recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
| St. Jans Gasthuis Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.