Myeloma XI’s Phase III trial result shows increase in myeloma patient remission


Myeloma XI has reported that the Phase III trial conducted in myeloma has indicated a 95% increase in progression-free survival (PFS) in myeloma patients receiving lenalidomide maintenance treatment.

Researchers from the trial have come to the conclusion that the use of maintenance lenalidomide treatment leads to highly significant improvements in PFS for patients of all ages, and therefore, it should be used as standard care.

This trial explored the use of oral lenalidomidetaken until disease progression, compared to no maintenance treatment in both newly diagnosed stem cell transplant eligible and transplant non-eligible myeloma patients.

The study’s results indicate the efficacy and tolerability of lenalidomide maintenance treatment by showing a median PFS of 37 months, compared to 19 months with no treatment.

Lenalidomide maintenance was found to be well tolerated. Out of those who stopped treatment, only 21.5% did so due to related toxicity, mostly due to neutropenia. A total of 48 cases of second primary malignancy (SPM) were observed in the maintenance group compared to 24 in the no maintenance group.

Myeloma UK board director and trial chief investigator, Prof Graham Jackson said: “This is a hugely successful trial combining so much hard work and the results are amazing, prolonging average remissions by up to two years.”

The trial was funded by Cancer Research UK and conducted by the University of Leeds.

Myeloma XI recruited more than 4,400 patients for the trial across 110 NHS hospitals. It explored the benefits of different combinations and sequences of treatment in newly diagnosed myeloma patients focusing on the impact that this had on progression free and overall survival rates.

"This is the largest clinical trial conducted in myeloma anywhere in the world."

University of Leeds’ the Leeds Institute of Clinical Trial Research principal statistician Dr David Cairns said: “This is the largest clinical trial conducted in myeloma anywhere in the world.

"Approximately 20% of all newly diagnosed patients in the UK since 2010 have participated in it. Being involved in this trial has given these newly diagnosed patients access to drugs that they couldn’t get on the NHS.

"Continuous treatment with lenalidomide has been shown to double the average time until relapse; 37 months versus 19 months without treatment.

"The time to the first disease progression is a surrogate for a patient’s survival from the disease, and so such a big improvement at this stage will hopefully translate to better prognosis. Although we do see a slight increase in the incidence of SPM, we believe the benefits of lenalidomide maintenance far outweigh the risk of SPM.”


Image: Micrograph of a plasmacytoma. Photo: Courtesy of Nephron/Wikipedia