Carfilzomib [CAR1]

The treatment of previously treated multiple myeloma where all the following crtieria are met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with carfilzomib plus 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 diagnosis of multiple myeloma.
  3. The patient has relapsed or progressing disease.
  4. The patient has received 1 and only 1 prior line of treatment and that the numbering of a line of treatment is in accordance with the International Myeloma Workshop Consensus recommendations for the uniform reporting of clinical trials (http://doi.org/10.1182/blood-2010-10-299487). A line of therapy is defined as one or more cycles of a planned treatment program. This may consist of one or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner (eg induction chemotherapy/chemotherapies if followed by stem cell transplantation then maintenance is considered to be 1 line of therapy). A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse or toxicity. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. Note: the use of carfilzomib in combination with dexamethasone in patients who have had 1 and only 1 prior line of therapy is because of NICE’s specific recommendation for routine commissioning. The use of carfilzomib in combination with dexamethasone in the 2- or more prior line patient groups is not permitted.
  5. One of the following options applies as to any previous systemic therapy with bortezomib for this patient:
  • the patient has not received any previous treatment with bortezomib or
  • the patient has received prior bortezomib as part of 1st line treatment and there has been at least a 6- month proteasome inhibitor treatment-free interval from the last bortezomib dose.
  1. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
  2. Carfilzomib will only be administered in combination with dexamethasone and with no other systemic anticancer therapies.
  3. A formal medical review as to whether treatment with carfilzomib plus dexamethasone should continue or not will be scheduled to occur no later than by the end of the 2nd month of therapy.
  4. Where a treatment break of more than 12 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break form to restart treatment, including an indication as appropriate if the patient had an extended break because of COVID 19.
  5. Carfilzomib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 17 October 2017

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CDF Managed Access: NA

NICE Technology Appraisal: TA657 (previously TA475) (18 November 2020)

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