Daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone [DAR5]

For the treatment of newly diagnosed and treatment-naive patients with systemic immunoglobulin light chain amyloidosis (AL) where the following criteria have been met:

  1. This application is both being made by and the first cycle of systemic anti-cancer therapy with daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a histopathological diagnosis of newly diagnosed systemic immunoglobulin light chain amyloidosis (AL).
  3. The patient has previously not received any systemic anti-cancer therapy for systemic light chain amyloidosis except for an emergency use of a short course of corticosteroids before this treatment. Note: patients who have already commenced any systemic therapy for light chain amyloidosis (AL) other than corticosteroids are not eligible for treatment with this daratumumab combination.
  4. The patient is potentially eligible or not for a future autologous stem cell transplant. Please indicate this below:
  • may be eligible for future stem cell transplantation or
  • will not be eligible for future stem cell transplantation Note: patients having stem cell transplantation during therapy with daratumumab will not be able to re-start with this daratumumab combination after the stem cell transplantation.
  1. The patient has at least 1 form of organ involvement by the systemic light chain amyloidosis (AL). Forms of organ involvement could be cardiac, renal, hepatic, nervous system, gastrointestinal tract, lung and soft tissue. Please tick one of the boxes below:
  • 1 known form of organ involvement or
  • 2 known forms of organ involvement or
  • 3 or more known forms of organ involvement
  1. The patient has known cardiac involvement by the amyloidosis or not:
  • yes, there is known cardiac involvement or
  • no, there is not known cardiac involvement
  1. The patient has known renal involvement by the amyloidosis or not:
  • yes, there is known renal involvement or
  • no, there is not known renal involvement
  1. The cardiac staging as described by the European adaptation of the Mayo Clinic Cardiac staging system which is based on the assessment of 2 serum biomarker risk factors being raised: the NT-proBNP above 332ng/L (N-terminal pro-B-type natriuretic peptide) and the high sensitivity cardiac troponin T above 54ng/L. Stage I: no risk factors positive Stage II: 1 risk factor positive Stage III: both risk factors positive Please mark below which above cardiac stage applies to this patient:
  • Stage I or
  • Stage II or
  • Stage III
  1. The patient has class I or II or IIIA or IIIB New York Heart Association class of heart failure (see below). Note: NYHA class IV patients are not eligible for daratumumab in this indication. Class I: no limitation in physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnoea or anginal pain. Class II: slight limitation of physical activity. Patient is comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnoea or anginal pain. Class IIIA: comfortable at rest. Less than ordinary activity results in fatigue, palpitation, dyspnoea or anginal pain. Class IIIB: comfortable at rest. Shortness of breath with performance of activities of daily living (dressing, toileting, showering etc). Class IV: shortness of breath at rest. Unable to carry on any physical activity without discomfort. Signs/symptoms of heart failure or anginal syndrome may be present at rest. If any physical activity is undertaken, discomfort is increased. Please mark below which NYHA class is appropriate for this patient:
  • Class I or
  • Class II or
  • Class IIIA or
  • Class IIIB
  1. The renal amyloidosis staging for this patient using recent measurements of urine albumin to creatinine ratio and estimated eGFR using the Cockcroft and Gault formula. Stage I: both urine albumin to creatinine ratio (ACR) <500mg/mmol and eGFR ≥50mls/min per 1.73m² Stage II: either urine albumin to creatinine ratio (ACR) =>500mg/mmol or eGFR <50mls/min per 1.73m² Stage III: both urine albumin to creatinine ratio (ACR) >=500mg/mmol and eGFR <50mls/min per 1.73m² Please mark below which renal staging applies to this patient:
  • Stage I or
  • Stage II or
  • Stage III (continued on next page)

[NHS funded]{.badge .rounded-pill .bg-success} From: 25 June 2024

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CDF Managed Access: NA

NICE Technology Appraisal: TA959 (27 March 2024)

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