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FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)
Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
599
Start Date
2024-05-14
Completion Date
2037-12
Last Updated
2024-08-19
Healthy Volunteers
No
Conditions
Interventions
Daratumumab Injection
Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)
Dexamethasone
Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)
Lenalidomide capsule
Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)
Locations (38)
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
NL-Almere-FLEVOZIEKENHUIS
Almere Stad, Netherlands
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
NL-Amsterdam- UMC
Amsterdam, Netherlands
NL-Amsterdam-AmsterdamUMC
Amsterdam, Netherlands
NL-Apeldoorn-GELREAPELDOORN
Apeldoorn, Netherlands
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
NL-Assen-WZA
Assen, Netherlands
NL-Beverwijk-RKZ
Beverwijk, Netherlands
NL-Delft-RDGG
Delft, Netherlands
NL-Deventer-DZ
Deventer, Netherlands
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Nij Smellinghe Ziekenhuis
Drachten, Netherlands
NL-Ede-ZGV
Ede, Netherlands
NL-Emmen-SCHEPER
Emmen, Netherlands
NL-Enschede-MST
Enschede, Netherlands
NL-Goes-ADRZ
Goes, Netherlands
NL-Gorinchem-BEATRIX
Gorinchem, Netherlands
NL-Groningen-MARTINI
Groningen, Netherlands
NL-Hardenberg-SAXENBURGH
Hardenberg, Netherlands
NL-Harderwijk-STJANSDALHARDERWIJK
Harderwijk, Netherlands
NL-Helmond-ELKERLIEK
Helmond, Netherlands
NL-Hilversum-TERGOOI
Hilversum, Netherlands
NL-Hoofddorp-SPAARNEGASTHUIS
Hoofddorp, Netherlands
NL-Hoorn-DIJKLANDERHOORN
Hoorn, Netherlands
Alrijne Ziekenhuis Leiderdorp
Leiderdorp, Netherlands
HMC Antoniushove
Leidschendam, Netherlands
NL-Roosendaal-BRAVIS
Roosendaal, Netherlands
NL-Rotterdam-IKAZIA
Rotterdam, Netherlands
NL-Schiedam-FRANCISCUSVLIETLAND
Schiedam, Netherlands
NL-Sittard-Geleen-ZUYDERLAND
Sittard, Netherlands
NL-Sneek-ANTONIUSSNEEK
Sneek, Netherlands
NL-Terneuzen-ZORGSAAM
Terneuzen, Netherlands
NL-Tilburg-ETZ
Tilburg, Netherlands
NL-Uden-BERNHOVEN
Uden, Netherlands
NL-Venlo-VIECURI
Venlo, Netherlands
NL-Zaandam-ZAANSMC
Zaandam, Netherlands
NL-Zwolle-ISALA
Zwolle, Netherlands