Table 1.
Induction treatment | |||
Regimen: CVRDd to maximum response (or a maximum of 6 cycles of bortezomib) | Cycle duration: 21 days | ||
Drug | Dose | Route | Days |
Cyclophosphamide | 500 mg | PO | 1 and 8 |
Bortezomib | 1.3 mg/m2 | SC | 1, 4, 8, 11 |
Lenalidomide | 25 mg | PO | 1–14 |
Daratumumab | 16 mg/kg (actual body weight) | IV | 1, 8, 15† (cycles 1 and 2) |
1 only (cycle 3 onwards) | |||
Dexamethasone* | 20–40 mg | PO/IV | 1, 4, 8, 11 |
Autologous stem cell transplant (ASCT)
Cyclophosphamide and GCSF mobilisation is recommended | |||
Regimen: bortezomib HD-MEL+ASCT | |||
Drug | Dose | Route | Days |
Melphalan | 200 mg/m2 | IV | −1 |
Bortezomib | 1.3 mg/m2 | SC | −1, (8–18 hours post Melphalan) |
Autologous stem cell return | IV | 0 | |
Bortezomib | 1.3 mg/m2 | SC | +5, +14, then weekly to consolidation 1 |
Consolidation treatment 1
To begin between 100 and 120 days post ASCT | |||
Regimen: VRDd×6 cycles* | Cycle duration: 28 days | ||
Drug | Dose | Route | Days |
Bortezomib | 1.3 mg/m2 | SC | 1, 8,15, 22 |
Lenalidomide | 25 mg | PO | 1–21 |
Daratumumab | 16 mg/kg (actual body weight) | IV | 1 |
Dexamethasone* | 20–40mg | PO/IV | 1, 8,15†, 22 |
Consolidation treatment 2 | |||
Regimen: VRD×12 cycles* | Cycle duration: 28 days | ||
Drug | Dose | Route | Days |
Bortezomib | 1.3 mg/m2 | SC | 1, 8,15 |
Lenalidomide | 25 mg | PO | 1–21 |
Daratumumab | 16 mg/kg (actual body weight) | IV | 1 |
Maintenance treatment | |||
Regimen: RD until progression | Cycle duration: 28 days | ||
Drug | Dose | Route | Days |
Lenalidomide | 10 mg | PO | 1–21 |
Daratumumab | 16 mg/kg (actual body weight) | IV | 1 |
*On days where participants receive dexamethasone 40 mg at site (i.e. predaratumumab infusion), dexamethasone must not be self-administered at home too.
†On day 15, participants will receive premed as per SPC (eg, methylprednisolone).
CVRDd, cyclophosphamide, bortezomib (Velcade), lenalidomide (Revlimid), daratumumab (Darzalex), dexamethasone; GCSF, granulyte colony-stimulating factor; HD-MEL, high dose melphalan; IV, intravenous; RD, lenalidomide, daratumumab; SC, subcutaneous; SPC, summary of product characteristics; VRD, bortezomib, lenalidomide, daratumumab; VRDd, bortezomib, lenaliomide, daratumumab, dexamethasone.