Status:
RECRUITING
FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)
Lead Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 trea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT06187441
Start Date
May 14 2024
End Date
December 1 2037
Last Update
August 19 2024
Active Locations (38)
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1
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
2
NL-Almere-FLEVOZIEKENHUIS
Almere Stad, Netherlands
3
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
4
NL-Amsterdam- UMC
Amsterdam, Netherlands