Belantamab mafodotin in combination with bortezomib and dexamethasone [BELA1]

Belantamab mafodotin in combination with bortezomib and dexamethasone as 2nd line treatment of relapsed or refractory myeloma in adult patients where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant, or internally accredited haematology specialty trainee, specifically trained and assessed in the use of systemic anti-cancer therapy.
2. The patient has a confirmed diagnosis of multiple myeloma.

Note

Note: patients with amyloidosis or POEMS syndrome are not eligible for belantamab mafodotin.

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

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. Whether the patient has been previously treated with an immunomodulatory agent Please tick the box which applies to this patient:

• No, the patient has not been treated with an immunomodulatory agent
• Yes, the patient has been treated with an immunomodulatory agent as part of a standard of care regimen
• Yes, the patient has been treated with an immunomodulatory agent as part of a clinical trial

5. 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

6. 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 an anti-CD38 antibody or
• Yes, the patient has been previously treated with a 1st line anti-CD38 antibody or
• Yes, the patient has been previously treated with another 1st line anti-CD38 antibody-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 an anti-CD38 antibody or
• Yes, the patient has been previously treated with a 1st line anti-CD38 antibody 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

11. 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.
12. 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.
13. The use of belantamab mafodotin will otherwise be as described in the drug’s Summary of Product Characteristics (SPC).

NHS funded From: 29 July 2026

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA1149 (30 April 2026)

Current Form Version

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• BELA1_prior_to_cdf_1.386
• BELA1_prior_to_cdf_1.406