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

Inclusion Criteria:

• Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease atthe time of diagnosis (appendix A).

• Age ≥ 18 years.

• Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and willcontinue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to lessthan 5 mg, and previous discontinuation or dose reduction of dexamethasone isallowed.

• Partial response or better after treatment with 12 cycles of Dara-Rd, without signsof biochemical progression.

• ANC ≥ 1.0x109/L and platelets ≥ 75x109/L.

• Patient is capable of giving informed consent.

• Written informed consent.

Exclusion Criteria:

• Patient with non-secretory MM at diagnosis of the disease, i.e., before the start oftreatment with Dara-Rd.

• Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of thedisease, i.e., before the start of treatment with Dara-Rd.

• Patient in whom urine M-protein was the only measurable parameter at diagnosis ofthe disease, i.e., before the start of treatment with Dara-Rd.

• Patient in whom treatment with daratumumab, lenalidomide or both has beendiscontinued for whatever reason (patients may only have discontinueddexamethasone).

• Patient in whom continuation of treatment with Dara-Rd is deemed not feasiblebecause of medical reasons.

• Any psychological, familial, sociological and geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule.