Published

May 11, 2025

Lenalidomide [LEN6]

Lenalidomide monotherapy as maintenance treatment in newly diagnosed patients with multiple myeloma who have undergone autologous stem cell transplantation where the following criteria have been met:

  1. This application for maintenance lenalidomide is being made by and the first cycle of systemic anti-cancer therapy with maintenance lenalidomide monotherapy 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.
  3. The patient has recently undergone autologous stem cell transplantation.
  4. The patient has had an adequate haematological recovery following autologous stem cell transplantation.
  5. Just prior to this application the patient has been tested for and has no evidence of disease progression since the transplantation was done.
  6. The prescribing clinician understands that maintenance lenalidomide is recommended to start at about day 100 after stem cell transplantation. Please enter in the box below the number of days since stem cell transplantation:
  7. The patient has had no previous therapy with lenalidomide unless the patient has been previously treated with 1st line lenalidomide allowed for transplant eligible patients via the interim treatment change options available during the coronavirus pandemic (blueteq form LEN1aCV will previously have been completed) or if the patient has been receiving NHS approved free of charge supply of maintenance lenalidomide as part of the NIHR myeloma XI trial and is due to exit the trial on study closure or if the patient has been receiving NHS approved free of charge supply of maintenance lenalidomide as part of the NIHR RADAR trial and whilst still in remission has chosen to exit the trial or the patient chose to self-fund ‘top-up’ treatment with lenalidomide maintenance prior to now switching to NHS funding as long as he/she started maintenance lenalidomide treatment on or after the 18th February 2020*. Please tick one of the boxes below:
  • no previous therapy with lenalidomide or
  • the patient has been previously treated with 1st line lenalidomide (only in combination with dexamethasone) allowed for transplant eligible patients via the interim cancer treatment options available during the coronavirus pandemic (blueteq form LEN1aCV will previously have been completed) and this had been started before the 14th April 2022*.
  • the patient has been receiving NHS approved free of charge supply of maintenance lenalidomide as part of the NIHR myeloma XI trial and is due to exit the trial on study closure
  • the patient has been receiving NHS approved free of charge supply of maintenance lenalidomide as part of the NIHR RADAR trial and whilst still in remission has chosen to exit the trial
  • the patient has been receiving lenalidomide maintenance treatment via ‘top-up’ self-funding and this was started on or after 18th February 2020. * Access to the Interim treatment option LEN1aCV was removed by NHS England on 14th April 2022. The appraisal was scoped by NICE in May 2012, but NICE terminated the appraisal as the manufacturer did not make an evidence submission as to the clinical and cost effectiveness of maintenance lenalidomide. Because of this termination, there was no expectation that this indication could potentially receive NHS funding until an evidence submission from the manufacturer was finally received by NICE on 18th February 2020. NHS England will not fund any patients who started maintenance lenalidomide treatment before 18th February 2020 as there was no expectation of NHS funding potentially occurring until then as NICE had not received a submission from the company. Patients who are receiving lenalidomide maintenance funded by their private healthcare insurance provider should continue receive the full treatment course of lenalidomide from their private healthcare insurance provider.
  1. The patient has an ECOG performance status of 0 or 1 or 2.
  2. The patient will start maintenance lenalidomide at a dosing schedule of 10mg daily given on days 1-21 of a 28-day cycle and that any dose delays and reductions will be according to the Myeloma XI protocol version 9.0 (dated 2 November 2017). Note: this dosing schedule is not the licensed one as set out in the lenalidomide Summary of Product Characteristics but is the one on which NICE assessed the clinical and cost effectiveness of maintenance lenalidomide. Note: the licensed dosing schedule of maintenance lenalidomide is not to be used.
  3. My hospital Trust’s governance policy regarding the use of unlicensed treatments has been followed as I understand that the above Myeloma XI dosing schedule of maintenance lenalidomide is unlicensed.
  4. Lenalidomide is only to be used as monotherapy and that it is not to be used in combination with any other agents.
  5. Lenalidomide is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
  6. A first formal medical review as to whether treatment with maintenance lenalidomide monotherapy continues or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  7. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
  8. Lenalidomide will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 01 June 2021

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA680 (03 March 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.