Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Aim of this study is to evaluate Daratumumab effect on MRD-positive patients with Multiple
Myeloma (MM) who achieved >VGPR after any therapy (ASCT, VMP, Rev-Dex). Daratumumab 16 mg/kg
administered at weekly intervals for 8 weeks, then every 2 weeks for an additional 16 weeks,
will be given to 50 MM patients who achieved a >VGPR defined by monoclonal component
disappearance in serum or urine, immunofixation positive/negative and MRD-positivity (by
NGF). Free light chain (FLC) and CT/PET will be evaluated at time 0. NGF will be done on
marrow aspirate at time 0, at 2 months and every 6 months for 2 years. If patients will be
still MRD positive after 6 months of therapy , treatment will be continued up to 2 years. If
MRD negative by NGF, the patients can stop the treatment.