MODIFY

• Research type

  Research Study

• Full title

  Isatuximab And Iberdomide As Immunotherapy For High Risk Smouldering Myeloma (MODIFY)

• IRAS ID

  1007214

• Contact name

  Samim Patel

• Contact email

  samim.patel@ucl.ac.uk

• Research summary

  The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma.
  The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.

  Isa is a new antibody therapy that stimulates the body’s immune system to attack cancer cells. Iber is a type of drug called an "immunomodulatory” drug, which means that it kills myeloma cells by affecting the body’s immune system in different ways. Dex is a steroid that destroys myeloma cells and helps make the other drugs more effective.

  All patients will receive 2 years of treatment, over 26 cycles. A cycle is 28 days. The treatment is split into 3 stages.
  Induction therapy: Cycle 1-4
  -Isa is given once a week in cycle 1. Then twice a week in cycle 2-4. It is given through the skin in the abdomen using a new medical device.
  -Iber is given on days 1-21. It is given as an oral capsule.
  -Dex is given once a week. It is given as an oral tablet.

  Consolidation therapy: Cycle 5-13
  -Isa is given twice a week.
  -Iber is given on days 1-21

  Maintenance therapy: Cycle 14-26
  -Isa is given once a month
  -Iber is given on days 1-21

  The study is funded by Sanofi and Bristol Myers Squibb and will recruit patients from 20 UK hospitals. Patients will be followed up until the last patient completes their 1-year post-treatment follow up.

• REC name

  HSC REC A

• REC reference

  25/NI/0007

• Date of REC Opinion

  3 Mar 2025

• REC opinion

  Further Information Favourable Opinion