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. 2021 Mar 24;11(3):e046225. doi: 10.1136/bmjopen-2020-046225

Table 1.

Treatment schedule

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.