FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)
HOVON174MM
2 other identifiers
interventional
599
1 country
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started May 2024
Longer than P75 for phase_3 multiple-myeloma
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2023
CompletedFirst Posted
Study publicly available on registry
January 2, 2024
CompletedStudy Start
First participant enrolled
May 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2037
August 19, 2024
August 1, 2024
6.6 years
December 1, 2023
August 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Compare Event-Free Survival (EFS)
To compare Event-Free Survival (EFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD
Approximately up to 57 (EFS) months after randomization of the first patient
Compare Progression Free Survival (PFS)
To compare Progression Free Survival (PFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD
Approximately up to 69 (PFS) months after randomization of the first patient
Secondary Outcomes (14)
Compare adverse event burden
Approximately up to 69 months after randomization of the first patient
Compare patient-reported outcome measures (PROMs)
Approximately up to 69 months after randomization of the first patient
Compare cost-effectiveness between arms
Approximately up to 69 months after randomization of the first patient
Determine the length of the treatment-free interval
Approximately up to 69 months after randomization of the first patient
Determine time to (maximal) response response
Approximately up to 69 months after randomization of the first patient
- +9 more secondary outcomes
Study Arms (2)
Arm A
NO INTERVENTIONA continuous therapy arm - continuation of therapy with Dara-Rd until PD
Arm B
EXPERIMENTALtreatment free interval arm - discontinuation of therapy with Dara-Rd, which will be resumed at biochemical progression and given until PD
Interventions
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)
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)
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonja Zweegman, Prof Dr MD
Amsterdam UMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2023
First Posted
January 2, 2024
Study Start
May 14, 2024
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
December 1, 2037
Last Updated
August 19, 2024
Record last verified: 2024-08