DARZALEX® + bortezomib + Thalomid® (thalidomide) + dexamethasone
Adding DARZALEX® (daratumumab) to VTd resulted in significantly more patients with sCR vs VTd alone after consolidation1,2
sCR was assessed in the ITT population.
Primary endpoint: sCR assessed 100 days after transplant, or immediately following consolidation if greater than 100 days.
DARZALEX® + VTd post-consolidation responses1,2
CR=complete response; HR=hazard ratio; ITT=intent-to-treat; MM=multiple myeloma; OR=odds ratio; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).
53% reduction in the risk of disease progression or death with DARZALEX® + VTd vs VTd alone1,2*
*Based on interim analysis and the boundary for PFS was crossed.
~90% of patients in each treatment arm underwent ASCT2,3†
- 489 (90%) with DARZALEX® + VTd and 484 (89%) with VTd alone
- 100% of patients who received a transplant achieved hematopoietic reconstitution‡
- 85% of patients in the DARZALEX® + VTd group and 81% of those in the VTd group completed all 4 induction and both consolidation cycles at 18.8 months (median follow-up)
ASCT=autologous stem cell transplant; HR=hazard ratio; ITT=intent-to-treat; MM=multiple myeloma; PFS=progression-free survival; sCR=stringent complete response; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).
† In the ITT analysis, patients who did not receive ASCT were considered nonresponders for post-transplant analyses.
‡Neutrophils >0.5 × 109/L, leukocytes >1.0 × 109/L, and platelets >50 × 109/L (without transfusion).
DARZALEX® (daratumumab) + VTd consistently improved depth of response
Responses assessed 100 days after transplant, or immediately following consolidation if greater than 100 days1,3
93% ORR for DARZALEX® + VTd includes patients in the ITT population:
- With a PR or better at the prespecified time point
Response rates over time3,4
-
Post-induction, post-ASCT, and best response analyses were not adjusted for multiplicity.
This information is not included in the Prescribing Information - Median duration of follow-up was 18.8 months (0.0–32.2)
†Best response of stringent complete response (sCR), complete response (CR), sCR + CR, very good partial response (VGPR), VGPR or better (sCR + CR + VGPR), partial response (PR), overall response (sCR + CR + VGPR + PR), stable disease (SD), progressive disease (PD), and not evaluable (NE) were derived based on the computerized algorithm, according to IMWG response criteria, during the study treatment period.
ASCT=autologous stem cell transplant; IMWG=International Myeloma Working Group; ITT=intent-to-treat; ORR=overall response rate; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).