Carfilzomib in combination with lenalidomide and dexamethasone [CAR2]

For the treatment of previously treated multiple myeloma in patients who have had 1 prior line of systemic therapy where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with carfilzomib in combination with lenalidomide 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 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 and maintenance therapy 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 lenalidomide and dexamethasone in patients who have had 1 and only 1 prior line of therapy is because of NICE’s specific recommendation for this position in the myeloma treatment pathway. The use of carfilzomib in combination with lenalidomide and dexamethasone in the 2- or more prior line patient groups is not permitted.
5. The patient was treated with a bortezomib-containing regimen as part of 1st line treatment and the patient responded to this bortezomib-containing therapy. Note: the company, when making its submission to NICE, stipulated that it wished consideration of a recommendation only in the group of patients who had been previously treated with bortezomib. Note: the ASPIRE trial, on which the Amgen submission to NICE was based, included only patients who had responded to treatment. As Amgen restricted its submission to patients who had previously had 1 line of therapy, NICE’s recommendation is based on patients who had responded to a bortezomib-containing 1st line regimen.
6. The patient has not been previously treated with lenalidomide unless lenalidomide was received as part of induction therapy prior to a stem cell transplant. Please confirm whether the patient has received previous lenalidomide or not:

• the patient has not previously received any lenalidomide-containing therapy or
• the patient has received lenalidomide-containing chemotherapy but only as part of induction chemotherapy prior to a stem cell transplant Note: NICE’s decision-making as to its recommendation of carfilzomib in combination with lenalidomide and dexamethasone was based on patients who did not have progressive disease on 1st line lenalidomide-containing therapy or who were intolerant of 1st line lenalidomide.

7. The patient has not been previously treated with carfilzomib.
8. 1st line treatment either included stem cell transplantation or not:
9. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
10. The patient will receive a maximum of 18 cycles of carfilzomib and that a patient continuing to respond after completing 18 cycles of carfilzomib plus lenalidomide plus dexamethasone will continue on treatment with lenalidomide plus dexamethasone without carfilzomib.
11. Carfilzomib will only be administered in combination with lenalidomide and dexamethasone and with no other systemic anticancer therapies.
12. Carfilzomib (to a maximum of 18 cycles) plus lenalidomide plus dexamethasone is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or patient proceeds to stem cell transplant, whichever is the sooner Carfilzomib with lenalidomide and dexamethasone is intended to be used for transplant ineligible patients after relapse or progression of first line therapy. Any patient receiving carfilzomib with lenalidomide and dexamethasone in this indication who subsequently becomes transplant eligible and is then able to proceed to transplant cannot resume treatment post-transplant as carfilzomib with lenalidomide and dexamethasone is not funded as maintenance therapy post-transplant.
13. A formal medical review as to whether treatment with carfilzomib plus lenalidomide plus dexamethasone should continue or not will be scheduled to occur no later than by the end of the 2nd month of therapy.
14. Where a treatment break of more than 6 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
15. Carfilzomib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 27 July 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA695 (28 April 2021)

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.

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• CAR2_prior_to_cdf_1.361