Daratumumab, cyclophosphamide, bortezomib and dexamethasone for non-transplant eligible myeloma (AMaRC 03-16)

Peter Mollee, John Reynolds, Wojt Janowski, Hang Quach, Philip Campbell, Simon Gibbs, Sophie Lee, Edwin Lee, Kerry Taylor, Tara Cochrane, Craig Wallington-Gates, Fiona Kwok, Nicholas Weber, Ian Kerridge, Helen Weston, P. Joy Ho, Michael Francis Leahy, Noemi Horvath, Andrew Spencer

Research output: Contribution to journalArticlepeer-review

10 Downloads (Pure)


In newly diagnosed transplant-ineligible patients with myeloma, daratumumab has improved outcomes when added to the standard of care regimens. In a randomized trial, we tested whether similar improvements would be seen when daratumumab was added to the bortezomib, cyclophosphamide and dexamethasone (VCD) regimen. Non-transplant eligible patients with untreated myeloma were randomized to receive VCD or VCD plus daratumumab (VCDD). 121 patients were randomized, 57 in the VCD arm and 64 in the VCDD arm. Baseline characteristics were balanced between the two arms. The median PFS was 16.8m (95%CI 15.3 - 21.7m) and 25.8m (95%CI 19.9 - 33.5) in the VCD and VCDD arms, respectively (HR 0.67, log-rank test p=0.066). In a pre-planned analysis, the estimated PFS at fixed time-points post-randomization demonstrated significantly improved PFS for the daratumumab containing arm from 18 months onwards. The proportions of patients who were progression free at the following time points were: 18 months, 48% vs 68% (p=0.0002); 24 months, 36% vs 52% (p=0.0001); and 30 months, 27% vs 41% (p<0.0001) in the VCD and VCDD arms, respectively. The best overall response and VGPR rate were significantly better in the daratumumab arm (65% vs 86%, p=0.007 and 28% vs 52%, p=0.009) for the VCD and VCDD arms, respectively. Seventy-two percent of the VCDD patients completed the 9 cycles of induction therapy with no grade 3 or 4 peripheral neuropathy adverse events. This study supports VCDD as an option for the initial treatment of non-transplant eligible patients with myeloma. Australian and New Zealand Clinical Trials Registry (ACTRN12617000202369). https://www.anzctr.org.au/.
Original languageEnglish
Number of pages27
JournalBlood Advances
Publication statusAccepted/In press - 26 Apr 2024


  • myeloma
  • daratumumab
  • bortezomib
  • cyclophosphamide
  • dexamethasone
  • transplant-ineligible patients


Dive into the research topics of 'Daratumumab, cyclophosphamide, bortezomib and dexamethasone for non-transplant eligible myeloma (AMaRC 03-16)'. Together they form a unique fingerprint.

Cite this