Belantamab mafadotin in combination with bortezomib and dexamethasone, Belantamab mafadotin in combination with bortezomib and dexamethasone [BELA1, BELA1]

Belantamab mafadotin in combination with bortezomib and dexamethasone as 2nd line treatment of relapsed or refractory myeloma in adult patients who previously received lenalidomide as part of 1st line systemic therapy where the following criteria have been met:, Belantamab mafadotin in combination with bortezomib and dexamethasone as 2nd line treatment of relapsed or refractory myeloma in adult patients who previously received lenalidomide as part of 1st line systemic therapy where the following criteria have been met:

1. This application for belantamab mafadotin in combination with bortezomib and dexamethasone is being made by and the first cycle of systemic anti-cancer therapy with belantamab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a confirmed diagnosis of multiple myeloma. Note: patients with amyloidosis or POEMS syndrome are not eligible for belantamab mafadotin.
3. This patient has received 1 and only 1 prior line of systemic therapy for myeloma 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 1st line induction chemotherapy/chemotherapies when followed by stem cell transplantation and maintenance therapy is considered as 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, the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. 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: although the marketing authorisation is for patients with myeloma who have had at least 1 prior therapy, the company has initially sought a NICE recommendation for patients who have had only 1 prior line of treatment. Patients who have had more than 1 prior line of therapy are not eligible for treatment with this belantamab mafodotin combination.
4. This patient has been previously treated with a 1st line lenalidomide-containing regimen which is commissioned by NHS England or is part of a 1st line treatment regimen in a NIHR- badged clinical trial. Please confirm below which 1st line treatment was received by the patient:

• 1st line daratumumab plus lenalidomide and dexamethasone for transplant ineligible disease
• 1st line lenalidomide and dexamethasone for transplant ineligible disease
• maintenance lenalidomide post stem cell transplant as part of 1st line therapy
• lenalidomide was part of a 1st line treatment regimen in a NIHR-badged clinical trial Note: patients who have not received lenalidomide as part of their 1st line therapy are not eligible for treatment with this belantamab mafodotin combination.

5. The reason for discontinuing the 1st line lenalidomide was because of either disease progression on treatment or intolerance of lenalidomide. Please indication the reason for discontinuing the 1st line lenalidomide:

• disease progression on treatment or
• intolerance of lenalidomide

6. This patient has been previously treated with bortezomib or another proteasome inhibitor as part of 1st line therapy. Please tick the appropriate box which applies to this patient:

• No, the patient has not been previously treated with bortezomib or any other proteasome inhibitor or
• Yes, the patient has been previously treated with a 1st line bortezomib-containing regimen or
• Yes, the patient has been previously treated with another 1st line proteasome inhibitor-containing regimen in a clinical trial

7. This patient has been previously treated with an anti-CD38 antibody as part of 1st line therapy. Please tick the appropriate box which applies to this patient:

• No, the patient has not been previously treated with daratumumab or any other anti-CD38 antibody or
• Yes, the patient has been previously treated with a 1st line daratumumab-containing regimen or
• Yes, the patient has been previously treated with another 1st line anti-CD38 antibody-containing regimen in a clinical trial

8. The patient has been previously treated as part of 1st line therapy with stem cell transplantation. Please tick the appropriate box which applies to this patient:

• No, the patient has not been previously treated as part of 1st line treatment with stem cell transplantation or
• Yes, the patient has been previously treated as part of 1st line treatment with stem cell transplantation

9. The patient has progressive disease during or following 1st line systemic anti-myeloma therapy.
10. The patient has an ECOG performance status of 0 or 1 or 2: Please record below the patient’s ECOG performance status: PS 0 or PS 1 or PS 2 Continued on the next page
11. Belantamab mafodotin will be used only in combination with bortezomib and dexamethasone and not with any other anti-myeloma agents.
12. The prescribing clinician is aware of the risk of corneal adverse reactions with belantamab mafodotin and that an ophthalmic examination including visual acuity and slit lamp examination must be performed by an eye care professional prior to each of cycles 1, 2, 3 and 4 and then during treatment as indicated.
13. Arrangements have been put in place for the eye care professional to categorize both the degree of any corneal damage and the best corrected visual acuity in the most severely affected eye and for these results to be communicated to the myeloma team.
14. Since belantamab mafodotin dose modifications are partly based on corneal examination findings and/or changes in best corrected visual acuity, the patient’s ophthalmic examination findings will be reviewed before dosing and will determine the belantamab mafodotin dose based on the highest category from the corneal examination and/or best corrected visual acuity finding in the most severely affected eye.
15. The patient will be advised to administer preservative-free artificial tears for use at least 4 times daily throughout the time of treatment with belantamab mafodotin.
16. The patient should avoid using contact lenses until the end of belantamab mafodotin treatment unless bandage contact lenses are used under the direction of an ophthalmologist.
17. The patient will be treated with belantamab mafodotin until disease progression or the occurrence of excessive toxicity or the withdrawal of patient consent, whichever is the sooner.
18. A formal medical review as to how belantamab mafodotin is being tolerated and whether treatment with belantamab should continue or not will be scheduled to occur after each of the first 4 cycles of treatment.
19. The prescribing clinician understands that given the potentially necessary frequency and duration of treatment breaks during treatment with belantamab mafodotin, this indication is exempt from NHS England’s treatment break policy. Note: if there is disease progression during a treatment break from belantamab mafodotin, treatment with belantamab mafodotin must be discontinued.
20. The use of belantamab mafodotin will otherwise be as described in the drug’s Summary of Product Characteristics (SPC).

CDF funded From: 12 June 2025

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The data on this page was produced using version 1.366 of the CDF list, downloaded from NHS England’s website on 12 June 2025 at 14:00.

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