TCD15484 (R/R)

A multi-center, open-label, Phase 1b study to assess the pharmacokinetics, safety and efficacy of subcutaneous isatuximab (SAR650984) in combination with pomalidomide and dexamethasone, in patients with relapsed/refractory multiple myeloma

Study treatment

• Arm 1: isatuximab subcutaneous
• Arm 2: isatuximab intravenous

Inclusion criteria

• diagnosis of Multiple myeloma and currently require treatment because Multiple myeloma has relapsed following a response
• has received at least two previous therapies, including lenalidomide and proteasome inhibitor and had demonstrated disease progression on last therapy or after completion of the last therapy
• measurable disease

Exclusion criteria

• Diagnosed or treated for another malignancy within 3 years prior to enrollment
• ECOG > 2
• Primary refractory or intolerant to prior therapy with any anti-CD38 MoAb or had disease progression during anti-CD38 MoAb, administered as last therapy

• Previous allegenic stem cell transplantation with active GVHD or being under immunosuppressive therapy in the last 2 months previously to the inclusion of the trial

Participating sites

• University Hospital Leuven Gasthuisberg