EMN19

Title

Daratumumab combined with Bortezomib, Cyclophosphamide and Dexamethasone for Treatment of Myeloma Patients Presenting with Extramedullary Disease. The Antares Study

Study map

Overview / Summary

The study is conducted in co-sponsorship with EMN Trial Office s.r.l. i.s.

 

Study details

Forty patients have been enrolled.

Patient eligibility criteria

1. Newly Diagnosed or 1st relapse MM patients with EMN (paraskeletal plasmacytomas ONLY are not eligible)
2. ECOG PS ≤ 2. Note: for subjects with CNS involvement, an ECOG PS > 2 is also acceptable
3. Measurable Disease (Serum. urine or sFLC MM)
4. Non refractory to bortezomib based regimens
5. No prior treatment with anti-CD38 or anti-CS1 MoAB
6. Adequate Bone Marrow function (minimum laboratory requirements)
7. No ASCT within 12 weeks of C1D1
8. No prior allo-SCT (regardless of timing)

Publications