Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06187441

FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)

Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2024-08-19

599

Participants Needed

38

Research Sites

707 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple myeloma based on IMWG criteria with measurable disease at diagnosis
  • Aged 18 years or older
  • Treated with 12 (or 13) cycles of daratumumab-lenalidomide-dexamethasone and planning to continue this treatment
  • Achieved partial response or better after 12 cycles without biochemical progression
  • Absolute neutrophil count (ANC) of 1.0 x 10^9/L or higher and platelets of 75 x 10^9/L or higher
  • Able to provide informed consent
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Non-secretory multiple myeloma at diagnosis before starting Dara-Rd treatment
  • Only plasmacytoma as a measurable parameter at diagnosis before starting Dara-Rd
  • Only urine M-protein as a measurable parameter at diagnosis before starting Dara-Rd
  • Discontinued daratumumab or lenalidomide treatment for any reason (dexamethasone discontinuation allowed)
  • Continuing Dara-Rd treatment not feasible for medical reasons
  • Psychological, familial, sociological, or geographical conditions that may affect compliance with study protocol and follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

Actively Recruiting

2

NL-Almere-FLEVOZIEKENHUIS

Almere Stad, Netherlands

Actively Recruiting

3

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

Actively Recruiting

4

NL-Amsterdam- UMC

Amsterdam, Netherlands

Actively Recruiting

5

NL-Amsterdam-AmsterdamUMC

Amsterdam, Netherlands

Actively Recruiting

6

NL-Apeldoorn-GELREAPELDOORN

Apeldoorn, Netherlands

Actively Recruiting

7

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

Actively Recruiting

8

NL-Assen-WZA

Assen, Netherlands

Actively Recruiting

9

NL-Beverwijk-RKZ

Beverwijk, Netherlands

Actively Recruiting

10

NL-Delft-RDGG

Delft, Netherlands

Actively Recruiting

11

NL-Deventer-DZ

Deventer, Netherlands

Actively Recruiting

12

NL-Dordrecht-ASZ

Dordrecht, Netherlands

Actively Recruiting

13

Nij Smellinghe Ziekenhuis

Drachten, Netherlands

Actively Recruiting

14

NL-Ede-ZGV

Ede, Netherlands

Actively Recruiting

15

NL-Emmen-SCHEPER

Emmen, Netherlands

Actively Recruiting

16

NL-Enschede-MST

Enschede, Netherlands

Actively Recruiting

17

NL-Goes-ADRZ

Goes, Netherlands

Actively Recruiting

18

NL-Gorinchem-BEATRIX

Gorinchem, Netherlands

Actively Recruiting

19

NL-Groningen-MARTINI

Groningen, Netherlands

Actively Recruiting

20

NL-Hardenberg-SAXENBURGH

Hardenberg, Netherlands

Actively Recruiting

21

NL-Harderwijk-STJANSDALHARDERWIJK

Harderwijk, Netherlands

Actively Recruiting

22

NL-Helmond-ELKERLIEK

Helmond, Netherlands

Actively Recruiting

23

NL-Hilversum-TERGOOI

Hilversum, Netherlands

Actively Recruiting

24

NL-Hoofddorp-SPAARNEGASTHUIS

Hoofddorp, Netherlands

Actively Recruiting

25

NL-Hoorn-DIJKLANDERHOORN

Hoorn, Netherlands

Actively Recruiting

26

Alrijne Ziekenhuis Leiderdorp

Leiderdorp, Netherlands

Actively Recruiting

27

HMC Antoniushove

Leidschendam, Netherlands

Actively Recruiting

28

NL-Roosendaal-BRAVIS

Roosendaal, Netherlands

Actively Recruiting

29

NL-Rotterdam-IKAZIA

Rotterdam, Netherlands

Actively Recruiting

30

NL-Schiedam-FRANCISCUSVLIETLAND

Schiedam, Netherlands

Actively Recruiting

31

NL-Sittard-Geleen-ZUYDERLAND

Sittard, Netherlands

Actively Recruiting

32

NL-Sneek-ANTONIUSSNEEK

Sneek, Netherlands

Actively Recruiting

33

NL-Terneuzen-ZORGSAAM

Terneuzen, Netherlands

Actively Recruiting

34

NL-Tilburg-ETZ

Tilburg, Netherlands

Actively Recruiting

35

NL-Uden-BERNHOVEN

Uden, Netherlands

Actively Recruiting

36

NL-Venlo-VIECURI

Venlo, Netherlands

Actively Recruiting

37

NL-Zaandam-ZAANSMC

Zaandam, Netherlands

Actively Recruiting

38

NL-Zwolle-ISALA

Zwolle, Netherlands

Actively Recruiting

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Research Team

S

Sonja Zweegman, Prof Dr MD

CONTACT

M

Maarten Seefat, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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