Daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone [DAR5 (CONT)]
For the treatment of newly diagnosed and treatment-naive patients with systemic immunoglobulin light chain amyloidosis (AL) where the following criteria have been met:
- The 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
- Daratumumab will only be given in combination with bortezomib, cyclophosphamide and dexamethasone and that it is not to be used in combination with any other agents.
- The dosage schedule of daratumumab will be as follows: weekly treatment given in weeks 1-8 (a total of 8 doses in 2 x 4-weekly cycles) 2-weekly treatment in weeks 9-24 (a total of 8 doses in 4 x 4-weekly cycles) and from then on 4-weekly. Note: the first administration of daratumumab can be given in split doses on different days if IV infusion is used instead of the preferred subcutaneous daratumumab formulation.
- A maximum of 6 cycles of the combination of daratumumab plus bortezomib, cyclophosphamide and dexamethasone will be given unless there is development of progressive disease, unacceptable toxicity or patient choice to stop treatment.
- Daratumumab monotherapy will continue to be given after completion of the combination therapy until whichever of the following events occurs first: the development of progressive disease, unacceptable toxicity or patient choice to stop treatment or after completion of a total 24 x 4-weekly cycles of daratumumab counted from the first cycle of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone. Note: daratumumab cannot be continued with any other systemic therapy after completion of the initial combination of daratumumab, bortezomib, cyclophosphamide and dexamethasone. Note: there is no funding for daratumumab after completion of a total of 24 x 4-weekly cycles. It is therefore important that at the time of consenting, patients are informed of this maximum daratumumab treatment duration.
- 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.
- A formal medical review as to whether treatment with daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone continues or not will be scheduled to occur at least by the end of the second 4-weekly cycle of treatment.
- When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
- The National Amyloidosis Centre is auditing the outcomes of treatment-naïve patients commencing this daratumumab combination for light chain amyloidosis and details of this audit can be obtained by emailing Darren Foard (Clinical Nurse Specialist) at darren.foard@nhs.net Note: NHS England strongly recommends participation in this audit which will provide real world evidence of this combination including data in patients with renal and cardiac involvement (some groups of which were excluded from the registration trial).
- Daratumumab will be otherwise used as set out in its Summary of Product Characteristics.
NHS funded From: 25 June 2024
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.