CD38 expression on plasma cells in newly-diagnosed or relapsed/ refractory multiple myelo...

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`RF-MM-CD38-EXPRESSION-DARA-CANDIDATE`
Тип	Тривожна ознака
Статус	переглянуто 2026-04-29 \| очікує клінічного підпису
Хвороби	`DIS-MM`
Джерела	`SRC-ALCYONE-MATEOS-2018` `SRC-CASTOR-PALUMBO-2016` `SRC-ESMO-MM-2023` `SRC-MAIA-FACON-2019` `SRC-NCCN-MM-2025` `SRC-POLLUX-DIMOPOULOS-2016`

Походження тривожної ознаки

Визначення	CD38 expression on plasma cells in newly-diagnosed or relapsed/ refractory multiple myeloma — universally high on malignant plasma cells (>95% MM), making CD38-targeting monoclonal antibodies a backbone class. Daratumumab (anti-CD38 IgG1κ; IV original / SC formulation post-2020) integrated into multiple regimens: D-VRd / D-VTd induction (transplant-eligible newly-diagnosed), D-Rd (MAIA Facon 2019 NEJM — mPFS not reached vs 31.9 mo, OS HR 0.66 in transplant-ineligible NDMM), D-Vd (CASTOR Palumbo 2016 NEJM — mPFS 16.7 vs 7.1 mo), D-Rd post-Len exposure (POLLUX Dimopoulos 2016 NEJM — mPFS 44.5 vs 17.5 mo), D-VMP (ALCYONE Mateos 2018 NEJM — mPFS not reached vs 19.3 mo in transplant-ineligible NDMM). Isatuximab (anti-CD38 IgG1κ; alternative CD38 mAb; IKEMA, ICARIA-MM data). Gates CD38-mAb-naive cohort; addresses CD38-loss-of-expression escape on prior CD38 exposure (~30-50% transient downreg...
Клінічний напрям	intensify
Категорія	high-risk-biology

Логіка спрацьовування

{
  "all_of": [
    {
      "any_of": [
        {
          "finding": "cd38_expression",
          "value": "positive"
        },
        {
          "finding": "cd38_status",
          "value": "expressed"
        },
        {
          "finding": "cd38_flow",
          "value": "positive"
        },
        {
          "finding": "cd38_ihc",
          "value": "positive"
        }
      ]
    },
    {
      "any_of": [
        {
          "finding": "prior_cd38_mab_exposure",
          "value": false
        },
        {
          "finding": "cd38_mab_naive",
          "value": true
        },
        {
          "finding": "newly_diagnosed_mm",
          "value": true
        },
        {
          "finding": "relapsed_refractory_mm",
          "value": true
        }
      ]
    }
  ],
  "type": "composite_score"
}

Нотатки

CD38 expression is universal in MM — RF acts as enabler/eligibility signal rather than rare-event flag. Severity = moderate (rather than major) reflects this: it routes the patient toward a CD38-mAb-containing arm but does not flag adverse biology. Daratumumab SC (1800 mg + hyaluronidase) preferred over IV for IRR mitigation (~13% SC vs ~50% IV any grade). Pre-medication: acetaminophen 650-1000 mg + dexamethasone 20 mg + diphenhydramine 25-50 mg + montelukast 10 mg (cycle 1). Schedule: weekly cycles 1-2, q2w cycles 3-6, q4w cycle 7+. Interferes with type-and-screen (anti-CD38 binds RBC CD38) — pre-transfusion phenotype required. HBV reactivation risk — screening + prophylaxis. CD38 loss-of- expression after prior daratumumab exposure typically transient; re-treatment feasibility depends on duration off-therapy + flow re-assessment. STUB — requires clinical co-lead signoff.

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