Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Noordwest Ziekenhuisgroep Stichting
Coordinator of this site? Confirm its status
AlkmaarNetherlandsRecruiting
Ziekenhuisgroep Twente Stichting
Coordinator of this site? Confirm its status
AlmeloNetherlandsRecruiting
Flevoziekenhuis Stichting
Coordinator of this site? Confirm its status
AlmereNetherlandsRecruiting
Meander Medisch Centrum
Coordinator of this site? Confirm its status
AmersfoortNetherlandsRecruiting
Ziekenhuis Amstelland
Coordinator of this site? Confirm its status
AmstelveenNetherlandsRecruiting
Stichting OLVG
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Amsterdam UMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Gelre Hospitals
Coordinator of this site? Confirm its status
ApeldoornNetherlandsRecruiting
Rijnstate Ziekenhuis Stichting
Coordinator of this site? Confirm its status
ArnhemNetherlandsRecruiting
Wilhelmina Ziekenhuis Assen
Coordinator of this site? Confirm its status
AssenNetherlandsRecruiting
Maasziekenhuis Pantein B.V.
Coordinator of this site? Confirm its status
BeugenNetherlandsRecruiting
Rode Kruis Ziekenhuis B.V.
Coordinator of this site? Confirm its status
BeverwijkNetherlandsRecruiting
Amphia Hospital
Coordinator of this site? Confirm its status
BredaNetherlandsRecruiting
IJsselland Ziekenhuis
Coordinator of this site? Confirm its status
Capelle aan den IJsselNetherlandsRecruiting
Reinier de Graaf Groep
Coordinator of this site? Confirm its status
DelftNetherlandsRecruiting
Deventer Ziekenhuis
Coordinator of this site? Confirm its status
DeventerNetherlandsRecruiting
Het Van Weel-Bethesda Ziekenhuis
Coordinator of this site? Confirm its status
DirkslandNetherlandsRecruiting
Slingeland Ziekenhuis
Coordinator of this site? Confirm its status
DoetinchemNetherlandsRecruiting
Albert Schweitzer Ziekenhuis
Coordinator of this site? Confirm its status
DordrechtNetherlandsRecruiting
Ziekenhuis Nij Smellinghe
Coordinator of this site? Confirm its status
DrachtenNetherlandsRecruiting
Ziekenhuis Gelderse Vallei Stichting
Coordinator of this site? Confirm its status
Ede GldNetherlandsRecruiting
Máxima Medisch Centrum
Coordinator of this site? Confirm its status
EindhovenNetherlandsRecruiting
Catharina Ziekenhuis Stichting
Coordinator of this site? Confirm its status
EindhovenNetherlandsRecruiting
Treant Ziekenhuiszorg Stichting
Coordinator of this site? Confirm its status
EmmenNetherlandsRecruiting
Medisch Spectrum Twente
Coordinator of this site? Confirm its status
EnschedeNetherlandsRecruiting
St. Anna Ziekenhuis
Coordinator of this site? Confirm its status
GeldropNetherlandsRecruiting
Zuyderland Medisch Centrum Stichting
Coordinator of this site? Confirm its status
GeleenNetherlandsRecruiting
Admiraal de Ruijter Ziekenhuis
Coordinator of this site? Confirm its status
GoesNetherlandsRecruiting
Beatrix Ziekenhuis
Coordinator of this site? Confirm its status
GorinchemNetherlandsRecruiting
Groene Hart Ziekenhuis
Coordinator of this site? Confirm its status
GoudaNetherlandsRecruiting
Universitair Medisch Centrum Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting
Stichting Martini Ziekenhuis
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting
Saxenburgh Medisch Centrum
Coordinator of this site? Confirm its status
HardenbergNetherlandsRecruiting
Ziekenhuis St Jansdal
Coordinator of this site? Confirm its status
HarderwijkNetherlandsRecruiting
Frisius MC
Coordinator of this site? Confirm its status
HeerenveenNetherlandsRecruiting
Elkerliek ziekenhuis
Coordinator of this site? Confirm its status
HelmondNetherlandsRecruiting
Tergooiziekenhuizen
Coordinator of this site? Confirm its status
HilversumNetherlandsRecruiting
Spaarne Gasthuis
Coordinator of this site? Confirm its status
HoofddorpNetherlandsRecruiting
Dijklander Ziekenhuis
Coordinator of this site? Confirm its status
Hoorn NhNetherlandsRecruiting
Frisius MC
Coordinator of this site? Confirm its status
LeeuwardenNetherlandsRecruiting
Alrijne Zorggroep Stichting
Coordinator of this site? Confirm its status
LeiderdorpNetherlandsRecruiting
University Hospital Maastricht
Coordinator of this site? Confirm its status
MaastrichtNetherlandsRecruiting
Sint Antonius Ziekenhuis Stichting
Coordinator of this site? Confirm its status
NieuwegeinNetherlandsRecruiting
Canisius-Wilhelmina Hospital
Coordinator of this site? Confirm its status
NijmegenNetherlandsRecruiting
Laurentius Ziekenhuis Roermond
Coordinator of this site? Confirm its status
RoermondNetherlandsRecruiting
Bravis Ziekenhuis
Coordinator of this site? Confirm its status
RoosendaalNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Ikazia Ziekenhuis
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Maasstad Ziekenhuis Stichting
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Ommelander Ziekenhuis Groningen B.V.
Coordinator of this site? Confirm its status
ScheemdaNetherlandsRecruiting
Sint Franciscus Vlietland Groep Stichting
Coordinator of this site? Confirm its status
SchiedamNetherlandsRecruiting
Medical Center Haaglanden
Coordinator of this site? Confirm its status
's-GravenhageNetherlandsRecruiting
Haga Hospital
Coordinator of this site? Confirm its status
's-GravenhageNetherlandsRecruiting
Jeroen Bosch Ziekenhuis
Coordinator of this site? Confirm its status
's-HertogenboschNetherlandsRecruiting
Antonius Ziekenhuis Sneek
Coordinator of this site? Confirm its status
SneekNetherlandsRecruiting
ZorgSaam Ziekenhuis
Coordinator of this site? Confirm its status
TerneuzenNetherlandsRecruiting
Ziekenhuis Rivierenland
Coordinator of this site? Confirm its status
TielNetherlandsRecruiting
St. Elisabeth Hospital Tilburg
Coordinator of this site? Confirm its status
TilburgNetherlandsRecruiting
Bernhoven B.V.
Coordinator of this site? Confirm its status
UdenNetherlandsRecruiting
Diakonessenhuis Stichting
Coordinator of this site? Confirm its status
UtrechtNetherlandsRecruiting
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Coordinator of this site? Confirm its status
VenloNetherlandsRecruiting
Zaans Medisch Centrum Stichting
Coordinator of this site? Confirm its status
ZaandamNetherlandsRecruiting
Isala Klinieken Stichting
Coordinator of this site? Confirm its status
ZwolleNetherlandsRecruiting
St. Jans Gasthuis
Coordinator of this site? Confirm its status
-NetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.