EMN18

Title

A multicenter, open label, randomized phase ii study comparing daratumumab combined with bortezomib-cyclophosphamide-dexamethasone (dara-vcd) versus the association of bortezomib-thalidomide-dexamethasone (vtd) as pre transplant induction and post transplant consolidation, both followed by a maintenance phase with ixazomib alone or in combination with daratumumab, in newly diagnosed multiple myeloma (mm) young patients eligible for autologous stem cell transplantation

Study map

Overview / Summary

Primary obiectives of part 1 of the study (e.g. induction+ASCT+consolidation) will be the following:

• To compare the efficacy of Dara-VCd to that of VTd in terms of progression free survival (PFS) at 3 years from first randomization (24 months from second randomization)
• To compare the efficacy of Dara-VCd to that of VTd in terms of minimal residual disease (MRD) negativity rate (≥10-5 sensitivity level) after induction and consolidation therapy

 

Primary objectives of part 2 of the study (e.g. maintenance) will be the following:

• To compare the efficacy of daratumumab-ixazomib to that of single-agent ixazomib in terms of MRD negativity rate (≥10-5 sensitivity level) and probability of conversion from MRD positivity (10-3 and 10-4 sensitivity levels) to MRD negativity (≥10-5 sensitivity level) by the end of maintenance therapy
• To compare the efficacy of daratumumab-ixazomib to that of single-agent ixazomib in terms of PFS at 2 years from second randomization to maintenance therapy.

Study details

Participating countries:

• Czech Republic (6 sites)
• Italy (19 sites)
• Greece (3 sites)

Patient eligibility criteria

About 400 newly diagnosed young multiple myeloma patients.

• Patient at least 18 years of age and ≤ 65 years.
• Patient eligible for ASCT.

Publications