DARZALEX® Clinical Studies:

DARZALEX® in combination with Velcade®
(bortezomib) + thalidomide + dexamethasone

DARZALEX® was studied in combination with Velcade® + thalidomide + dexamethasone (DVTd) vs VTd alone in 1085 patients with newly diagnosed multiple myeloma who can receive a stem cell transplant.

  1. In this study, patients received initial (induction) therapy with either DARZALEX® + VTd (n=543) or VTd alone (n=542).
  2. After induction, patients received high-dose chemotherapy and an autologous stem cell transplant, a type of stem cell transplant that uses their own stem cells.
  3. Patients received consolidation with either DARZALEX® + VTd (n=543) or VTd alone (n=542). Consolidation therapy is given to help kill any cancer cells that may be left in the body after initial therapy and transplant.

The main goal of the study was to measure stringent complete response, also known as sCR, which is a robust measure reflecting deep responses.

Another goal of the study was to measure the length of time patients lived without their multiple myeloma getting worse.

Clinical study results: DARZALEX® + VTd vs VTd alone

More patients achieved stringent complete response (sCR) with DARZALEX® in combination with DVTd compared with patients treated with VTd alone.

  • 29% of patients treated with DARZALEX® + VTd (n=543) achieved sCR vs 20% of patients treated with VTd (n=542) alone.
  • The overall response rate (which includes all levels of response) was 93% of patients treated with DARZALEX® + VTd vs 90% of patients treated with VTd alone.

DARZALEX® in combination with VTd increased the time patients lived without their multiple myeloma getting worse.

of patients lived without their disease getting worse with
DARZALEX® + VTd (n=543) vs 83% with VTd alone (n=542).*

*At a median follow-up of 18.8 months.