The CASSIOPEIA Trial: DARZALEX® + VTdin Transplant-Eligible Newly DiagnosedMultiple Myeloma1


DARZALEX® + bortezomib + Thalomid® (thalidomide) + dexamethasone

CASSIOPEIA study design

Phase 3 study comparing DARZALEX® + VTd vs VTd alonefor induction and consolidation1,2

  • In an ongoing part 2 of the study, patients underwent a second randomization in both treatment groups to either observation or DARZALEX® Q8W monotherapy for maintenance. The efficacy and safety of this maintenance regimen is currently being evaluated2

DARZALEX® dosing and administration: IV, 16 mg/kg actual body weight QW Cycles 1–2 and Q2W Cycles 3–4 (induction phase); Q2W Cycles 5–6 (consolidation phase).1

VTd dosing and administration: Bortezomib (V) SC or IV, 1.3 mg/m2 BSA twice weekly for 2 weeks on Days 1, 4, 8, 11 of repeated 28-day (4-week) induction cycles (Cycles 1–4) and 2 consolidation cycles (Cycles 5–6); thalidomide (T) PO, 100 mg daily during the 6 bortezomib cycles; dexamethasone (d) PO or IV, 40 mg on Days 1, 2, 8, 9, 15, 16, 22, 23 of Cycles 1 and 2, and at 40 mg on Days 1–2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16) of Cycles 3–4. Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5–6. On the days of DARZALEX® infusion, the dexamethasone dose was administered intravenously as a pre-infusion medication.1

  • Primary endpoint was stringent complete response (sCR) rate at Day 100 post-transplant: CR + normal free light-chain ratio + absence of clonal plasma cells + disappearance of all plasmacytomas1–3
  • Key secondary endpoints included: rate of CR or better, PFS from first randomization, OS from first randomization, and safety2–4
  • Patient characteristics: the median age was 58 years; 59% male; 48% had an ECOG performance score of 0, 42% had an ECOG performance score of 1, and 10% had an ECOG performance score of 2; 40% had ISS Stage I, 45% had ISS Stage II, and 15% had ISS Stage III disease1
  • Approval of frontline treatment of transplant-eligible MM patients is based on the response evaluation of Part 1 only of this trial at Day 100 post-transplant

BSA=body surface area; CR=complete response; DVTd=DARZALEX® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System; IV=intravenous; MM=multiple myeloma; NDMM=newly diagnosed multiple myeloma; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PO=bymouth; PR=partial response; Q2W=every 2 weeks; Q8W=every 8 weeks; QW=weekly; SC=subcutaneous; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).