HOVON HO174 MM

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Main info

Identificatie:
HOVON 174 MM
Sponsor:
HOVON
Working group party:
Myeloma
Stadium:
1st lijn
Echelon:
Level D
Included patients:
2
(of 599)
Active sites:
15
(of 65)
50 sites are pending
Title:

FeAsiBility of a treatment free interval in newly diagnosed mUltiple myeLOma patients treated with DaratumUmab-Lenalidomide-DexamethaSone – the FABULOUS study

A nationwide prospective open-label randomized phase III clinical trial comparing daratumumab-lenalidomide-dexamethasone continuously versus including a treatment free.

Timeline

Scheduled
Actual
2023
27 jul.
Development
2024
11 mrt.
EC Approval
2024
22 mrt.
Opportunity
2024
22 mrt.
Submission in Progress
2024
01 mei
EC Approval
2024
08 mei
First Site
2024
08 mei
FPI
2024
14 mei
Activated
2024
14 mei
First Site
2030
08 sep.
Endpoint Analysis

Flow

Flow

Details

Phase:
Prospective Phase III study
Monitoring Type:
HOVON Monitoring Visit
Objectives:

Primary objective:
• To compare Event-Free Survival (EFS) and Progression Free Survival (PFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until Progressive Disease versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at biochemical progression until Progressive Disease.

Secondary objectives:
• To compare toxicity and adverse event (AE) burden between arms.
• To compare Quality of Life (QoL) and additional PROMs between arms.
• To compare costs and effects between arms and calculate cost-effectiveness.
• To determine the length of the treatment-free interval (TFI) in arm B.
• To determine time to response and to maximal response after restart of Dara-Rd in arm B.
• To compare time to next treatment (TTNT) between arms
• To compare PFS2 between arms.
• To compare OS between arms.
• To compare the discontinuation rate and the reasons for discontinuation between arms.
• To evaluate cumulative dose and relative dose intensity (RDI) of daratumumab, lenalidomide and dexamethasone in both arms.
• To compare dose reductions of daratumumab, lenalidomide and dexamethasone between arms.

Eligibility

Inclusion Criteria:

In order to be eligible to participate in this study, a patient must meet all of the following criteria:
• Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A of the protocol).
• Age ≥ 18 years.
• Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and is eligible to continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg/day*, and previous discontinuation or dose reduction of dexamethasone is allowed.

  • Only for patients on dialysis 5 mg/ 2 days is allowed.

• PR 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 Criteria:

A patient who meets any of the following criteria cannot be included in this study:
• 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.

Registration Details

Eligible patients should be registered before start of treatment. Patients need to be registered at HOVON by one of the following options:

  • By ALEA; Use goto eCRF button > select the [Patient tab] and click the [Add new patient] button. Complete all items and click the [Submit] button
  • By phone +31 (0)10 704 1560 Monday through Friday, from 09:00 to 17:00 CET
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Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
65 results
Order by
Accrual rate
Activation date
NL-Gorinchem-BEATRIX
2
31 mei 2024
NL-Scheemda-OZG
NL-Nijmegen-CWZ
NL-Harderwijk-STJANSDALHARDERWIJK
NL-Groningen-MARTINI
NL-Almere-FLEVOZIEKENHUIS
NL-Eindhoven-CATHARINA
NL-Roosendaal-BRAVIS
NL-Leidschendam-HMCANTONIUSHOVE
19 jun. 2024
NL-Hilversum-TERGOOI
12 jun. 2024
NL-Gouda-GROENEHART
15 mei 2024
NL-Goes-ADRZ
NL-Dirksland-VANWEELBETHESDA
NL-Leiderdorp-ALRIJNELEIDERDORP
NL-Utrecht-DIAKONESSENUTRECHT
NL-Roermond-LZR
NL-Rotterdam-IKAZIA
17 jun. 2024
NL-Beugen-MAASZIEKENHUIS
NL-Weert-STJANS
NL-Heerenveen-TJONGERSCHANS
NL-Hardenberg-SAXENBURGH
NL-Drachten-NIJSMELLINGHE
NL-Assen-WZA
NL-Doetinchem-SLINGELAND
NL-Emmen-SCHEPER
11 jun. 2024
NL-Sneek-ANTONIUSSNEEK
21 jun. 2024
NL-Zaandam-ZAANSMC
18 jun. 2024
NL-Winterswijk-SKBWINTERSWIJK
NL-Venlo-VIECURI
11 jun. 2024
NL-Terneuzen-ZORGSAAM
14 jun. 2024
NL-Sittard-Geleen-ZUYDERLAND
NL-Uden-BERNHOVEN
NL-Capelle a/d IJssel-YSL
NL-Almelo-ZGTALMELO
NL-Dordrecht-ASZ
NL-Arnhem-RIJNSTATE
07 jun. 2024
NL-Amsterdam-VUMC
14 jun. 2024
NL-Groningen-UMCG
NL-Nieuwegein-ANTONIUS
NL-Amsterdam-OLVG
NL-Enschede-MST
NL-Amersfoort-MEANDERMC
NL-Eindhoven-MAXIMAMC
NL-Maastricht-MUMC
NL-Den Bosch-JBZ
29 mei 2024
NL-Zwolle-ISALA
NL-Den Haag-HAGA
NL-Rotterdam-ERASMUSMC
NL-Deventer-DZ
NL-Ede-ZGV
NL-Geldrop-STANNA
NL-Helmond-ELKERLIEK
07 jun. 2024
NL-Tiel-RIVIERENLAND
NL-Apeldoorn-GELREAPELDOORN
NL-Hoorn-DIJKLANDERHOORN
20 jun. 2024
NL-Beverwijk-RKZ
14 mei 2024
NL-Alkmaar-NWZ
NL-Delft-RDGG
NL-Leeuwarden-MCL
NL-Amstelveen-AMSTELLAND
NL-Schiedam-FRANCISCUSVLIETLAND
NL-Tilburg-ETZ
NL-Hoofddorp-SPAARNEGASTHUIS
NL-Rotterdam-MAASSTADZIEKENHUIS
NL-Breda-AMPHIA
= Active hospitals
= Inactive hospitals

Participating Parties

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