The first Spanish patient with multiple myeloma treated with commercial CAR-T, disease-free after 7 months

The first Spanish patient with multiple myeloma treated with commercial CAR-T at the 12 de Octubre public University Hospital in the Community of Madrid is disease-free just seven months after receiving this advanced therapy, after it was officially approved outside of a clinical trial.

José Ramón, a 57-year-old municipal police officer, was diagnosed with multiple myeloma eight and a half years ago. Despite undergoing several treatments , including a hematopoietic stem cell transplant, he suffered several relapses, the last one last year.

The team from the Hematology service at Hospital 12 de Octubre evaluated the option of CAR-T treatment and requested its administration outside of a clinical trial. After being officially authorized, José Ramón received the therapy.

«The CAR-T treatment was short, to be honest. I was admitted to the hospital for eight days , initially it was going to be a little longer, but the treatment worked very quickly and very well, and I was able to discharge soon. And I returned to work, I am a municipal police officer. I continue working, I continue doing sports, I continue with my day-to-day life, as if I had nothing,» he explained in statements sent to the media.

CAR-T treatment is individualized, requires a single administration , and is intended for patients with hematological tumors who have no other therapeutic options and who have a very low survival rate in most cases.

"José Ramón is a patient with refractory multiple myeloma who has no adequate treatment options and has been the first patient in Spain treated with a commercially available CAR-T therapy. He is currently in complete remission, disease-free, after 7 months of starting treatment ," explained Joaquín Martínez López, head of the Hemarology Service at Hospital 12 de Octubre.

These therapies, at least in this type of blood cancer, have proven to be much more effective than conventional treatments and offer very good long-term results. The therapeutic process begins with apheresis, which consists of extracting a very large number of T lymphocytes - a type of white blood cell - from your own blood, using a specialized blood filtration technique known as leukapheresis, which is performed intravenously.

The extracted cells are then reprogrammed and multiplied outside the body so that, when reinfused into the patient, they are able to recognise and combat cancer cells much more effectively. This genetic reprogramming process is carried out in a laboratory outside the hospital, generally in the United States, which leads to the commercialisation phase of the treatment.

The treatment must meet rigorous quality standards for the supply and manufacture of cells, in order to ensure patient safety. All of this requires compliance with very exhaustive requirements, as well as in-depth knowledge and expertise in care management.

"A commercial CAR-T is a personalized treatment for multiple myeloma in which lymphocytes are obtained from the patient, trained in a laboratory against the tumor and then infused. Commercial means that it has been approved by the European Medicines Agency and can be used in all patients," said Dr. López.

Based on these results, on October 12th, the same treatment was approved for eight more patients with the same pathology. Six patients have been infused and all are responding and disease-free, although follow-up is still short.

This hospital has proven training to administer this treatment. In January 2019, it provided the first CAR-T therapy and has treated more than 140 patients with hematological tumors to date, with excellent results.

"We have currently treated 42 patients with CAR-T treatments at the Hospital on October 12, 6 of them commercially. We have recently carried out an analysis of the evolution of these patients, 90% of the patients had responded and between 70 and 80% were still in remission," he said.

In addition, more than 80 patients with various hematological diseases are expected to receive it at the hospital this year, mainly because its indication has increased and the number of pathologies for which it can be administered has expanded.

“CAR-T therapy is a new opportunity for patients and represents an important advance ,” emphasizes Dr. Martínez López. “We are talking about an alternative for those who had no other therapeutic options and had a short life expectancy.”