COLUMBA Study Design
Subcutaneous DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) vs intravenous DARZALEX® (daratumumab)
COLUMBA is a phase 3, randomized, open-label, non-inferiority, multicenter trial comparing DARZALEX FASPRO® monotherapy vs DARZALEX® monotherapy in 522 adult patients with relapsed or refractory multiple myeloma.1
ECOG=Eastern Cooperative Oncology Group; PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
*Including a proteasome inhibitor (PI) and an immunomodulatory agent, or double refractory to a PI and an immunomodulatory agent.
- Baseline demographics and disease characteristics were similar between the 2 treatment groups1
The median age was 67 years (range: 33–92). The median weight was 73 kg (range: 29–138). Patients had received a median of 4 prior lines of therapy; 51% had a prior ASCT and 100% had received both a PI and an immunomodulatory agent
Non-inferiority co-primary endpoints
- Overall response rate† (ORR) and a maximum trough (Ctrough) concentration of daratumumab measured on Day 1 of Cycle 31
Selected secondary endpoints
- Percentage of patients with systemic administration-related reactions‡ (ARRs), very good partial response (VGPR) or better rate, complete response (CR) or better rate, and progression-free survival (PFS)2
ASCT=autologous stem cell transplant.
†According to International Myeloma Working Group (IMWG) response criteria.
‡In clinical trials of DARZALEX FASPRO® and DARZALEX®, and in the Prescribing Information for DARZALEX®, the terms “infusion reactions” and “infusion-related reactions” were used instead of “systemic administration-related reactions.”