11/29/2016 1 Function, Action and Interference of Anti-CD38 (DARA) Antibody in Blood Banking Joy Gould BB(ASCP)C, SBB, CQIA(ASQ), CPHQ Thomas Jefferson University Hospital Philadelphia, PA Objectives • Define Multiple Myeloma, its diagnosis, prognosis and treatment • Describe how anti-CD38 (DARA or Darzalex™) is used for treatment of these patients • Discuss how anti-CD38 may cause interference with antibody screening and identification in the transfusion service • Demonstrate ways to mitigate this interference by anti-CD38 Multiple Myeloma • Cancer of plasma cells which accumulate in the bone marrow • Feature production of a paraprotein or abnormal immunoglobulin light chain (M protein) • Common symptoms (CRAB) C – calcium elevated R – renal failure A – anemia B- bone lesions
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11/29/2016
1
Function, Action and
Interference of Anti-CD38
(DARA) Antibody in Blood
Banking Joy Gould
BB(ASCP)C, SBB, CQIA(ASQ), CPHQ Thomas Jefferson University Hospital
Philadelphia, PA
Objectives
• Define Multiple Myeloma, its diagnosis, prognosis and
treatment
• Describe how anti-CD38 (DARA or Darzalex™) is used for
treatment of these patients
• Discuss how anti-CD38 may cause interference with antibody
screening and identification in the transfusion service
• Demonstrate ways to mitigate this interference by anti-CD38
Multiple Myeloma
• Cancer of plasma cells which accumulate in the bone
marrow
• Feature production of a paraprotein or abnormal
immunoglobulin light chain (M protein)
• Common symptoms (CRAB)
C – calcium elevated
R – renal failure
A – anemia
B- bone lesions
11/29/2016
2
Treatment of Multiple Myeloma
• Considered incurable but treatable
• Focused on the decrease the clonal plasma cell population
Steroids
Chemotherapy
Proteasome inhibitors such as bortezomib
Immunomodulatory drugs such as thalidomide or lenalidomide
• Incidentally, 2 patients discovered hybrid altered C
antigen on molecular/serology testing
• 8 patients with GATA mutation
11/29/2016
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TJUH Experience
• 1 patient no specimen or testing post DARA after 6 doses;
hgb stable
• 4 patients – just starting treatment
References
• FDA approves Darzalex for patients with previously treated multiple myeloma, November 16, 2015, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472875.htm
• DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma, November 16, 2015, https://www.jnj.com/news/all/DARZALEX-daratumumab-Approved-by-US-FDA-First-Human-Anti-CD38-Monoclonal-Antibody-Available-for-the-Treatment-of-Multiple-Myeloma
• Resolving the daratumumab interference with blood compatibility testing, Chapuy, C., et al, Transfusion, Volume 55, June 2015, pages 1545-1554
• When blood transfusion medicine becomes complicated due to interference by monoclonal antibody therapy, Oostendorp, M., et al, Transfusion, Volume 55, June 2015, pages 1555-1562
• Judd’s Methods in Immunohematology, Third edition, AABB Press, 2008
• Clinical efficacy and management of monoclonal antibodies targeting CD38 and SLAMF7 in multiple myeloma, van de Donk, et al, Blood, Volume 127, Feb 11, 2016, page 6
• AABB Recommendations for Mitigating the Anti-CD38 Interference with Serological Testing, AABB, Dec 10, 2015
References
• Validation and Use of Serological CD38-Negative “DARA RBCs” as a Novel Method in Antibody Identification in Patients on Daratumumab Therapy, Velliquette, RW, et al, S56-030H, Transfusion, Vol 56 Supplement S4, 2016
• DTT’s DARA Dilemma, W Disbro, Immucor, SP261, page 135A, Transfusion, Vol 56 Supplement S4, 2016
• Extended Use of DTT-Treated Reagent Cells in the Era of Anti-CD38 Therapy, Lally, K, et al, SP264, page 136A, Transfusion, Vol 56 Supplement S4, 2016
• Daratumumab (DARZALEX®) Combination Therapy Significantly Extended Progression-Free Survival in Previously Treated Patients with Multiple Myeloma, June 5, 2016, http://www.prnewswire.com/news-releases/daratumumab-darzalex-combination-therapy-significantly-extended-progression-free-survival-in-previously-treated-patients-with-multiple-myeloma-300279804.html