Study: NCT05665140

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Isatuximab
Description: i.v. Induction Phase (Arm A and B): Induction Cycle 1 10 mg/kg D 1, 8, 15, 22, 29. Induction Cycle 2-3 10 mg/kg D 1, 15, 29 Consolidation Phase (Arm B): Consolidation Cycle 1-3 10 mg/kg D 1, 15, 29 Maintenance Phase (Arm A and B): Maintenance Cycle 1 and subsequent cycles 10 mg/kg D 1, 15, 29

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Isatuximab
Description: i.v. Induction Phase (Arm A and B): Induction Cycle 1 10 mg/kg D 1, 8, 15, 22, 29. Induction Cycle 2-3 10 mg/kg D 1, 15, 29 Consolidation Phase (Arm B): Consolidation Cycle 1-3 10 mg/kg D 1, 15, 29 Maintenance Phase (Arm A and B): Maintenance Cycle 1 and subsequent cycles 10 mg/kg D 1, 15, 29

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lenalidomide
Description: hard capsule for oral use. Induction Phase (Arm A and B): Induction Cycle 1-3 25 mg D1-14, 20-35. Consolidation Phase (Arm B): Consolidation Cycle 1-3 25 mg D1-14, 20-35. Maintenance Phase (Arm A and B): Maintenance Cycle 1-2 10 mg D1-28. Maintenance Cycle 3 and subsequent cycles 15 mg D1-28 if tolerable

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: hard capsule for oral use. Induction Phase (Arm A and B): Induction Cycle 1-3 25 mg D1-14, 20-35. Consolidation Phase (Arm B): Consolidation Cycle 1-3 25 mg D1-14, 20-35. Maintenance Phase (Arm A and B): Maintenance Cycle 1-2 10 mg D1-28. Maintenance Cycle 3 and subsequent cycles 15 mg D1-28 if tolerable

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bortezomib
Description: s.c. injection. Induction Phase (Arm A and B): Induction Cycle 1-3 1,3 mg/m² D1, 4, 8, 11, 22, 25, 29, 32. Consolidation Phase (Arm B): Consolidation Cycle 1-3 1,3 mg/m² D1, 4, 8, 11, 22, 25, 29, 32

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Description: s.c. injection. Induction Phase (Arm A and B): Induction Cycle 1-3 1,3 mg/m² D1, 4, 8, 11, 22, 25, 29, 32. Consolidation Phase (Arm B): Consolidation Cycle 1-3 1,3 mg/m² D1, 4, 8, 11, 22, 25, 29, 32

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: orally and i.v. Induction Phase (Arm A and B): Induction Cycle 1 20 mg p.o. D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. D1, 8, 15, 22 and 29. Induction Cycles 2 and 3 20 mg p.o. D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. D1, 15 and 29. Consolidation Phase (Arm B): Consolidation Cycle 1-3 20 mg p.o. on D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. on D1, 15 and 29

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: orally and i.v. Induction Phase (Arm A and B): Induction Cycle 1 20 mg p.o. D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. D1, 8, 15, 22 and 29. Induction Cycles 2 and 3 20 mg p.o. D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. D1, 15 and 29. Consolidation Phase (Arm B): Consolidation Cycle 1-3 20 mg p.o. on D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. on D1, 15 and 29

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: autologous stem cell transplant
Description: autologous stem cell transplant