54767414MMY2065 (LYNX) (R/R)

A phase 2 study comparing daratumumab subcutaneous administration in combination with carfilzomib  and dexamethasone (DKd) vs carfilzomib and dexamethasone (Kd) in subjects with multiple myeloma who have been previously treated with daratumumab IV

Inclusion criteria

• Evidence of a response (partial response or better based on investigator's determination of response by IMWG criteria) to daratumumab-containing IV therapy with response duration of at least 4 months
• Relapsed or refractory disease as defined as: a) Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or >60 days after cessation of treatment
• Received 1 or 2 prior line(s) of treatment of which one contained Dara IV, and completed Dara IV at least 3 months prior to randomization. 
• ECOG Performance Status score of 0, 1, or 2

Exclusion criteria

• Previous treatment with daratumumab within the last 3 months prior to randomization
• Discontinuation of Dara IV due to a daratumumab-related adverse event (AE)

Participating sites 

• ZNA Stuivenberg
• UZ Gent