CyBorD-DARA in Newly Diagnosed Transplant-Eligible Multiple Myeloma: Results from the 16-BCNI-001/CTRIAL-IE 16-02 Study Show High Rates of MRD Negativity at End of Treatment

Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):847-852. doi: 10.1016/j.clml.2022.07.011. Epub 2022 Jul 21.

Abstract

The phase 1b 16-BCNI-001/CTRIAL-IE 16-02 CyBorD-DARA trial investigated the combination of Daratumumab with cyclophosphamide, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma (NDMM), followed by autologous stem cell transplantation and Daratumumab maintenance. CR/sCR rates were 50% after transplant and 62.5% at end of treatment. The overall percentage of patients achieving complete response or better was 77.8%. Progression-free survival rate at end of maintenance was 81.3% and estimated 2-year overall survival was 88.9%. 37.5% of patients demonstrated sustained MRD negativity to a level of 10-5 from transplant to analysis at EOT. In this phase 1b study, we have shown CyBorD-DARA to be an effective and well-tolerated immunomodulatory agent-free regiment in transplant-eligible NDMM.

Trial registration: ClinicalTrials.gov NCT02874742 NCT03710603 NCT03901963 NCT04071457.

Keywords: Daratumumab; Minimal residual disease; Myeloma; Transplant; immunotherapy.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Bortezomib / therapeutic use
  • Cyclophosphamide / therapeutic use
  • Dexamethasone / therapeutic use
  • Hematopoietic Stem Cell Transplantation / methods
  • Humans
  • Multiple Myeloma* / drug therapy
  • Transplantation, Autologous
  • Treatment Outcome

Substances

  • Bortezomib
  • Cyclophosphamide
  • Dexamethasone

Associated data

  • ClinicalTrials.gov/NCT02874742
  • ClinicalTrials.gov/NCT03710603
  • ClinicalTrials.gov/NCT03901963
  • ClinicalTrials.gov/NCT04071457