Daratumumab in combination with bortezomib, thalidomide and dexamethasone [DAR3]

For induction and consolidation therapy transplant-eligible multiple myeloma 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, thalidomide 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 newly diagnosed multiple myeloma. Note: this daratumumab indication is not funded for patients with primary amyloidosis. Please confirm this by ticking the box below:
  • this patient does not have a diagnosis of primary amyloidosis
  1. The patient has not previously received any systemic anti-cancer therapy for myeloma except for an emergency use of a short course of corticosteroids before this treatment
  2. The patient is eligible for an autologous stem cell transplant after this induction therapy with the combination of daratumumab, bortezomib, thalidomide and dexamethasone.
  3. Daratumumab will be given in combination with bortezomib, thalidomide and dexamethasone in the four 28 day induction cycles pre-transplant and in the two 28 day cycles of post-transplant consolidation therapy. Note: daratumumab is not funded for this transplant-eligible indication in combination with other anti-myeloma drugs.
  4. The patient is of ECOG performance status 0 or 1 or 2. Please tick one of the boxes below:
  • performance status 0 or
  • performance status 1 or
  • performance status 2 of
  1. The dosage schedule of daratumumab will be as:
  • weekly treatment given in weeks 1-8 (a total of 8 doses)
  • 2-weekly treatment in weeks 9-16 (a total of 4 doses)
  • a pause for high-dose chemotherapy and stem cell transplantation
  • and then 2-weekly treatment in the 2 consolidation cycles of daratumumab (a total of 4 doses). The first administration of daratumumab can be given in split doses on different days if IV infusion is used instead of subcutaneous daratumumab.
  1. There will be no prescription of maintenance daratumumab after completion of the 2 post-transplant consolidation cycles of daratumumab, bortezomib, thalidomide and dexamethasone. Note: maintenance lenalidomide is funded to commence after completion of the 2 post-transplant consolidation cycles of daratumumab, bortezomib, thalidomide and dexamethasone.
  2. Hepatitis B virus screening has been recently done and that if positive hepatitis B viral serology is found, the patient will be monitored for hepatitis B virus reactivation as outlined in the daratumumab Summary of Product Characteristics.
  3. A formal medical review as to whether treatment with daratumumab in combination with bortezomib, thalidomide and dexamethasone continues or not will be scheduled to occur at least by the end of the second 4-weekly cycle of treatment.
  4. When a treatment break of more than 6 weeks beyond the expected cycle length* is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID-19. *Note the treatment cycle includes transplant, so, the break in treatment due to transplant does not require completion of a treatment break form.
  5. Daratumumab will be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 03 May 2022

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CDF Managed Access: NA

NICE Technology Appraisal: TA763 (02 February 2022)

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