Isatuximab in combination with bortezomib, lenalidomide, and dexamethasone [ISA2]

in combination (with bortezomib, lenalidomide, and dexamethasone) for the treatment of UNTREATED multiple myeloma when a stem cell transplant is UNSUITABLE where the following criteria have been met:

1. This application is both being made by and the first cycle of systemic anti-cancer therapy with isatuximab in combination with bortezomib, 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 newly diagnosed multiple myeloma.

Note

Note: this isatuximab indication is not funded for patients with primary amyloidosis. Please confirm this by ticking the box below: - this patient does not have a diagnosis of primary amyloidosis

3. The patient has previously not received any systemic anti-cancer therapy for myeloma except for either an emergency use of a short course of corticosteroids before this treatment or the patient commenced induction therapy with the combination of daratumumab plus bortezomib, thalidomide and dexamethasone with the intention of proceeding to a stem cell transplant but despite responding to such treatment the patient is now ineligible for transplantation. Please tick below which scenario applies to this patient:

• the patient has not received any prior systemic anti-cancer therapy
• the patient has only had an emergency use of a short course of corticosteroids
• the patient commenced induction therapy with the combination of daratumumab plus bortezomib, thalidomide and dexamethasone with the intention of proceeding to a stem cell transplant but despite responding to such treatment the patient is now ineligible for transplantation.

Note

Note: patients who have not responded to induction therapy with daratumumab plus bortezomib, thalidomide and dexamethasone are NOT allowed to switch to the isatuximab combination regimen outlined in this Blueteq form

4. The patient is ineligible for an autologous stem cell transplant.
5. Isatuximab will only be given in combination with bortezomib, lenalidomide and dexamethasone and that it is not to be used in combination with any other agents.
6. The patient is of ECOG performance status 0, 1 or 2 Please tick one of the boxes below:

• performance status 0 or
• performance status 1 or
• performance status 2

7. Isatuximab in combination with bortezomib, lenalidomide and dexamethasone will continue to be given until the development of progressive disease, unacceptable toxicity, or patient choice to stop treatment, whichever occurs first.
8. When a treatment break of more than 6 weeks beyond the expected 4-, or 6- (cycle one and two only) weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is re-commenced.
9. Isatuximab will be otherwise be used as set out in its Summary of Product Characteristics.

CDF funded From: 04 September 2025

Additional information

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CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

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