Main info

Identificatie:

HOVON 174 MM

Sponsor:

HOVON

Working group party:

Myeloma

Stadium:

1st lijn

Echelon:

Level D

Included patients:

0

(of 599)

Active sites:

0

(of 65)

65 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

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

Participating Sites

= Active hospitals

= Inactive hospitals