Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma

This study is for adults, aged 18 or over, who have recently been diagnosed with multiple myeloma and have already completed their initial treatment, including at least one stem cell transplant (ASCT). You would have received specific types of powerful initial treatments before the transplant, often involving a combination of four drugs, similar to those used in the GMMG-HD8 / DSMM XIX trials.

Importantly, after your transplant, your myeloma should have responded well, meaning there's only a partial amount of cancer left or even less. You should also be generally fit and well enough to take part and be able to understand what's involved in the study.

There are also some reasons why you might not be able to join. For example, if you have certain digestive problems that might stop your body from absorbing the medicine properly, or if you've had a bad allergic reaction to similar drugs in the past. Women who could become pregnant and men must agree to use effective contraception during the study.

If you join this study, you will be randomly assigned, like flipping a coin, to one of two treatment groups. One group will take iberdomide tablets, and the other will take iberdomide tablets plus receive isatuximab as an injection under the skin using a special device. In the first cycle, you will also receive a tablet called dexamethasone. These treatments will be given in cycles, with each cycle lasting 29 days, for a total of 39 cycles, which is about three years.

Throughout this time, you will have regular check-ups, including blood tests and bone marrow samples, to see how the treatment is working and to monitor your health. The researchers will be particularly interested in looking for any remaining myeloma cells in your bone marrow. The study aims to follow you for at least 36 months of maintenance therapy to understand the long-term effects of the treatments.