HOVON HO174 MM
Main info
- Identificatie:
- HOVON 174 MM
- Sponsor:
- HOVON
- Working group party:
- Myeloma
- Stadium:
- 1st lijn
- Echelon:
- Level D
- Included patients:
-
19(of 599)
- Active sites:
-
46(of 65)19 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 interval.
Timeline
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 ≥ 1.0x10^9/L and platelets ≥ 75x10^9/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
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.