Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive

Sponsor
Azienda Ospedaliera Universitaria Senese
Study ID
NCT03992170
Phase
PHASE2
Status
Unknown

Conditions

  • Myeloma Multiple

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab is a human monoclonal antibody (mAb) IgG1 that binds to the highly expressed CD38 protein on the surface of multiple myeloma cells and, at various levels, also in other types of cells and tissues. The CD38 protein has multiple functions, such as receptor-mediated adhesion, signal transduction activity and enzymatic activity.

Study Details

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.

Key Dates

Start date
Dec 31, 2018
Status verified
Jun 2019
Primary completion
Jun 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Patients will receive Daratumumab (16 mg/Kg day) every week for 8 weeks intravenous (8 infusions) and then every 2 weeks for 16 weeks intravenous (8 more infusions). If MRD positive by NGF, the patients will receive Daratumumab every 4 weeks for 80 weeks intravenous; if MRD negative by NGF, the patients can stop the treatment.

Primary Outcome Measure

Overall Responde Rate (ORR) [ Time Frame: every 6 months ]

Central Contacts

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