Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, open label clinical trial evaluating the safety of the combination of
belantamab mafodotin + the combination treatment VRd (bortezomib, lenalidomide,
dexamethasone) in newly diagnosed (ND) transplant eligible multiple myeloma (MM) patients.
Eligible patients will be included in the study and they will receive three induction cycles
with belantamab mafodotin (8-week cycles) and six induction cycles with VRd (4-week cycles).
Immediately after the fourth VRd cycle, and in the absence of progression or unacceptable
toxicity, mobilization of hematopoietic stem cells with G-CSF and subsequent apheresis will
take place. Then, patients will receive one additional induction cycle with belantamab
mafodotin (8-week cycle) and two additional induction cycles with VRd (4-week cycles)
followed by intensification with high-dose melphalan (200mg/m2) and the autologous stem cell
transplant. Three months after transplantation, and as long as clinical and hematological
conditions allow, patients will receive one cycle of consolidation with belantamab mafodotin
(8-week cycle) and two additional cycles of consolidation with VRd (4-week cycles) at the
same doses as during induction and, subsequently, patients will receive maintenance treatment
with lenalidomide (continuously until disease progression, patient withdrawal, unacceptable
toxicity, loss to follow up, end of study or death) and belantamab mafodotin (for 2 years).