Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Management of infusion-related reactions (IRRs) in patients (pts) receiving daratumumab plus standard of care for the treatment of multiple myeloma (MM) in the phase 3 studies CASTOR and POLLUX

Date

11 Sep 2017

Session

Haematological malignancies

Presenters

Phillipe Moreau

Citation

Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373

Authors

P. Moreau1, N. Rabin2, T. Plesner3, K. Weisel4, P. Sonneveld5, M. Mateos6, J.M. Schecter7, H. Amin7, S. Trivedi8, M.A. Dimopoulos9

Author affiliations

  • 1 Hematology, University Hospital Hôtel-Dieu, 44000 - Nantes/FR
  • 2 Department Of Haematology, University College London Hospitals NHS Trust, London/GB
  • 3 Vejle Hospital, University of Southern Denmark, Vejle/DK
  • 4 Universitaetsklinikum Tuebingen Der Eberhard-karls-universitaet, Abteilung fuer Innere Medizin II, Tuebingen/DE
  • 5 Department Of Hematology, Erasmus MC, Rotterdam/NL
  • 6 -, University of Salamanca Hospital, Salamanca/ES
  • 7 -, Janssen Research & Development, LLC, Raritan/US
  • 8 -, Janssen Research & Development, LLC, Spring House/US
  • 9 Department Of Clinical Therapeutics, National And Kapodistrian University Of Athens, School Of Medicine, “Alexandra” General Hospital, Athens/GR
More

Resources

Abstract 3062

Background

Daratumumab (D), a CD38-targeted monoclonal antibody, reduced the risk of MM progression or death by > 60% when combined with standard-of-care regimens in the phase 3 studies CASTOR (bortezomib [V] and dexamethasone [d] vs DVd; NCT02136134) and POLLUX (lenalidomide [R] and d vs DRd; NCT02076009). This analysis evaluated the management of D-related IRRs in the DVd and DRd arms of CASTOR and POLLUX.

Methods

Pts had MM and had received ≥1 line of therapy. In CASTOR, pts were given 8 21-day cycles of Vd (V 1.3 mg/m2 subcutaneously on Days 1, 4, 8, and 11; d 20 mg per os [PO]/intravenously [IV] on Days 1-2, 4-5, 8-9, and 11-12) ± D (16 mg/kg IV, weekly [QW] for Cycles 1-3, every 3 weeks [Q3W] for Cycles 4-8, then every 4 weeks [Q4W] thereafter). In POLLUX, pts were given 28-day cycles of Rd (R 25 mg PO on Days 1-21; d 40 mg QW) ± D (16 mg/kg IV QW for Cycles 1-2, every 2 weeks for Cycles 3-6, then Q4W thereafter). In addition, pre-infusion medication consisted of 20 mg d (or equivalent) IV/PO, 650-1000 mg paracetamol, and 25-50 mg diphenhydramine (or equivalent). Pts with high-risk respiratory complications received diphenhydramine on Days 1 and 2, a short-acting β2 adrenergic receptor agonist and control medications for lung disease after D infusion.

Results

All pts receiving D were given pre-infusion medication. In CASTOR and POLLUX, 31 (13%) and 21 pts (7%) received post-infusion medications, respectively. In both trials, the median duration of D infusion was ∼7.0, 4.3, and ∼3.4 hours for the first, second, and subsequent infusions, respectively. IRRs occurred in 45% and 48% of pts and 98% and 96% of IRRs occurred during the first infusion in CASTOR and POLLUX, respectively. Most IRRs were grade 1/2 and no grade ≥4 IRRs were reported. The median time to onset of IRRs after starting the first D infusion was 84 minutes in CASTOR and 90 minutes in POLLUX. In CASTOR, 2 pts discontinued treatment due to IRRs; in POLLUX, 1 pt discontinued D due to a grade 3 IRR, but continued Rd.

Conclusions

Most D-related IRRs occurred during the first infusion and were grade 1/2. D-related IRRs were easily managed with pre- and post-infusion medications.

Clinical trial identification

NCT02136134 and NCT02076009

Legal entity responsible for the study

Janssen Research & Development, LLC

Funding

Funding provided by Janssen Research & Development

Disclosure

P. Moreau: Honoraria & Consultancy: Celgen, Takeda, Janssen, Novartis, Amgen. Speakers Bureau: Janssen, Celgene. N. Rabin: Consultancy: Janssen, Amgen, Novartis, Takeda, Bristol-Myers Squibb. Honoraria: Janssen, Takeda. Speakers Bureau: Janssen, Celgene. T. Plesner: Consultancy: Janssen, Takeda. Research Funding: Janssen. Advisory Committee: Janssen, Genmab. K. Weisel: Consultancy & Honoraria: Amgen, Bristol-Myers Squib, Celgene, Janssen, Novartis, Takeda, Onyx. Research Funding: Janssen, Celgene, Amgen, Sanofi. P. Sonneveld: Consultancy & Research Funding & Honoraria: Amgen, Celgene, Janssen, Karyopharm, Takeda. M-V. Mateos: Consultancy & Honoraria: Janssen, Celgene, Takeda, Amgen. J.M. Schecter: Employment & Equity: Janssen. H. Amin, S. Trivedi: Employment: Janssen. M.A. Dimopoulos: Consultancy & Honoraria: Celgene, Janssen, Takeda, Amgen.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings