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Clinical cases and experiences of using Daratumumab therapy in the DGH setting

Clinical cases and experiences of using Daratumumab therapy in the DGH setting. Dr Rachel Hall Consultant Haematologist Royal Bournemouth and Christchurch NHS Foundation Trust. Clinical use of anti-CD38 M Ab in Myeloma. Setting: open labelled Daratumumab single agent in

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Clinical cases and experiences of using Daratumumab therapy in the DGH setting

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  1. Clinical cases and experiences of using Daratumumab therapy in the DGH setting Dr Rachel Hall Consultant Haematologist Royal Bournemouth and Christchurch NHS Foundation Trust

  2. Clinical use of anti-CD38 MAb in Myeloma • Setting: open labelled Daratumumab single agent in • Relapsed after 3 prior therapies (IMID and PI x 2 cycles) • Double refractory (PD within 60 days of last IMID/PI) • Weekly Dara infusions cycles 1 and 2 (8 doses) • Fortnightly Dara infusions cycles 3-6 (8 doses) • Monthly Dara infusions cycle 9 and thereafter

  3. Clinical use of anti-CD38 MAb in Myeloma • 3 clinical cases • Demographics • Outcomes • Toxicities • Impact on DGH work load • Experiences of staff with the drug

  4. Case 1: GW 52yr man • Diagnosis IgG kappa aged 47 yrs Jan 2010 Hants • Renal impairment: Creatinine 215 • Anaemia: Hb 95 • ISS 3 • Kappa 36,850 • No bone lesions on skeletal survey • FISH not performed • MGUS 2002 • NIDDM

  5. Case 1: GW 52yr man • CTD commenced x 6 cycles no issues • VGPR achieved • Renal function normal • Peripheral sensory neuropathy • HDM ASCT Oct 2010 • VGPR post • April 2012 PD • Lenalidomide/Dexa x 7 cycles • PD on treatment (refractory)

  6. Case 1: GW 52yr man • Feb 2013 Velcade/Dexa x 4 cycles; CR • July 2014 Velcade/Dexax 4 cycles; VGPR • ‘no funding for continued cycles’ • Jan 2016 PD: referred for consideration of clinical trial • Kappa 860, IgG15g (pp10g) • Creatinine normal • Hb normal • ECOG 0 • Eligible for Daratumumab study: commenced March 2016

  7. Case 1: GW 52yr man

  8. Case 1: GW 52yr man • Ist infusion nasal congestion: • Pre med M-Pred D1, oral Prednisolone D2-3 • D1 Antihistamine, Paracetamol • No further infusional reactions • From #1 D15 down to 3 hour infusion • IDDM medication changes required (Pred related) • In a PR (monoclonal pp 4g) • Kappa 135 with ratio 19 • Attending once monthly for 3 hours • No side effects • Working and looking after 11 year old son

  9. Case 2: AS 69yr man • Diagnosis IgG kappa aged 55yr 2002 London • Anaemia, hypercalcaemia, bone disease • CTD x 6, Mel 200 ASCT Nov 2002 • Thalidomide maintenance study Feb 2003 • Feb 2007 PD: Dexa added in to Thal maintenance • Oct 2008 PD: VCD #5 (PR) • 2nd Mel 200 ASCT July 2009

  10. Case 2: AS 69yr man • March 2011 PD: Lenalidomide/Dexa (PR) to Sept 2013 • Dec 2013 PD: MUK 6 (Pano/Vel/Thal/Dexa) 16 cycles (PR) • Maintenance panobinostat to March 2015 • Moved to Poole 2014 • May 2015 PD: BCMA antibody conjugate phase 1 trial • May 15 – April 16 (MR) • PD with bony lesions R humerus and L5 spine • Bone pain +++ Referred to Poole for local RT to bone lesions

  11. Case 2: AS 69yr man • Latest bony relapse Aug 2016; • # R humerus post RT requires humeral nail • Fall results in # L clavicle • Bone marrow with 10% PC • FISH: 1q21 gain • Hb and creatinine normal • IgG 13g (pp12g) • Kappa 206, ratio 36 • ECOG 2 • Eligible for Daratumumab study: commenced Sept 2016

  12. Case 2: AS 69yr man

  13. Case 2: AS 69yr man • Ist infusion nasal congestion and wheeze: • Pre med M-Pred D1, oral Prednisolone D2-3 • D1 Antihistamine, Paracetamol • No further infusional reactions • From #1 D15 down to 3 hour infusion • In a PR (monoclonal pp 3g) • Kappa 29 with ratio 5.3 • Attending once weekly for 3 hours • No side effects • Bone pain improved, off morphine

  14. Case 3: SR 67yr woman • Diagnosis IgA lambda aged 57yr 2008 Bournemouth • Likely MGUS IgA 6.7g W+W • 2014: lambda 4149, IgA 0.5g • Hb 104, creatinine normal, B2m 7.4 • Marrow 22% PC • FISH: sample unsuitable for processing • Skeletal survey normal • Feb 2014: CTD x 6 (PR lambda 369) • Sept 2014: Mel 200 ASCT (VGPR) • August 2015: PD lambda 957, quickly rising to 5000 Nov 15

  15. Case 3: SR 67yr woman • Nov 15: MUK 5 study: Carfilzomib/Cyclo/Dexa • Initial PR • Refractory disease cycle 5 lambda 1609 May 16 • Holiday to Ireland • July 16 lambda 9750, sternal and L acetabular lesions • Commenced Lenalidomide/Dexa (+Ixazomib) • PR to lambda 1780 Aug 16 • Sept 2016 PD lambda 5000, ^ sternal lesion ECOG 2 • Eligible for Daratumumab study: commenced Oct 2016

  16. Case 3: SR 67yr woman

  17. Case 3: SR 67yr woman • 3 infusions • Minor infusional reaction with #1 D1 • #1 D22 bloods: • Hb 77 g/L, WCC 2.0 (neuts 0.8), platelets 4 x 109/l • Creatinine 174, eGFR 20 • Expanding sternal lesion • PD, taken off trial, palliative care

  18. Toxicities/tolerability • Minimal toxicities • Grade 1-2 infusional reaction in all patients D1 #1 • ‘instant flu’ • Nasal drip • Bronchospasm • Nausea • Stop infusion, antihistamine, paracetamol • All D1 infusions completed fully • No further reactions with later doses • 3 hour infusions from D15 #1

  19. Toxicities/tolerability • Mild ALT / AST rise in few patients • Resolved spontaneously, no delays • All anaemic patients (except rapid PD patient) Hb resolved to normal on treatment. • No neutropenia or thrombocytopenia

  20. Impact on service provision • Heavy impact on day unit initially • Mon - Sat 8am – 6pm • 1st infusion up to 10 hours • Close nursing monitoring /observations • Intervention for reactions • Once #1 D15 3 hour infusion rate: less onerous • Monthly infusions very well tolerated by all

  21. Summary • Current experience in heavily pre treated patient group +/- refractory disease • Very well tolerated in all with minimal toxicities • Excellent responses in most patients • NOT double refractory / aggressive disease group • Quick responses (PR post cycle 1) • ? Duration of responses

  22. Thank you

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