Selinexor in combination with bortezomib and dexamethasone [SELIN1]

For the treatment of multiple myeloma transplant ineligible patients who have had only 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 selinexor in combination with bortezomib 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 prescribing clinician understands that the combination of selinexor plus bortezomib and dexamethasone is not funded for amyloidosis patients (with the exception of patients who have a proven diagnosis of myeloma with an associated diagnosis of amyloidosis) and that NHS funding for selinexor plus bortezomib and dexamethasone is only for the specific 2nd line multiple myeloma indication recommended by NICE. Please tick box below:

• this patient does not have a diagnosis of primary amyloidosis
• this patient has a proven diagnosis of progressive myeloma with an associated diagnosis of amyloidosis and the combination of selinexor plus bortezomib and dexamethasone is being prescribed for the myeloma

4. The patient has received 1 and no more than 1 prior line of systemic 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 (ie induction chemotherapy/chemotherapies when followed by stem cell transplantation 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, 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. Please verify that the patient has only received 1 prior line of systemic therapy by ticking the box below:

• this patient has received 1 and no more than 1 prior line of systemic treatment and this patient is therefore receiving selinexor plus bortezomib and dexamethasone as 2nd line therapy in

Note

Note: The use of the combination of selinexor plus bortezomib and dexamethasone in the 1-prior treatment setting was one of the places in the treatment pathway chosen by Menarini Stemline for its submission to NICE for the appraisal of clinical and cost effectiveness of this combination and the 1-prior treatment setting is the only place in the treatment pathway that currently has a positive NICE recommendation for this combination.

5. The patient has demonstrated disease progression whilst receiving or after receiving 1st line combination therapy which contained both an anti-CD38 targeted antibody and lenalidomide.

Note

Note: the need for patients to have myeloma which was or has become refractory to a 1st line combination therapy containing both an anti-CD38 targeted antibody and lenalidomide is the basis of the 1-prior subgroup chosen by Menarini Stemline for its submission to NICE for the appraisal of clinical and cost effectiveness of this combination of selinexor plus bortezomib and dexamethasone as 2nd line systemic therapy.

6. The patient is ineligible for high dose chemotherapy and stem cell transplantation.
7. 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

8. Selinexor is only to be used in combination with bortezomib and dexamethasone and that it is not to be used in combination with any other agents.
9. The combination of selinexor plus bortezomib and dexamethasone is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment
10. A formal medical review as to whether treatment with selinexor in combination with bortezomib and dexamethasone continues or not will be scheduled to occur at least by the end of the second 5-week cycle of treatment, which MUST be approved before Selinexor is restarted.
11. Selinexor will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 13 August 2024

Additional information

Form version: 1.1

CDF Managed Access: NA

NICE Technology Appraisal: TA974 (15 May 2024)

Current Form Version

Note

The data on this page was produced using version 1.380 of the CDF list, downloaded from NHS England’s website on 25 December 2025 at 11:00.

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.