In the largest study of its kind, researchers at Newcastle University have led national research into the treatment of patients with newly diagnosed myeloma.

The results, published online today by The Lancet Oncology, show an improvement for those who received ongoing therapy with a drug called lenalidomide, compared to those not receiving it.

Improved outcomes

Findings of the study identified that long-term therapy with lenalidomide (also known as Revlimid®) doubles remission duration and also improves survival in younger patients by almost 8%.

Myeloma is a cancer of the plasma cells and it can affect several areas of the body, such as the spine, skull, pelvis and ribs. Current treatment usually involves chemotherapy and a stem-cell transplant.

Professor Graham Jackson, from the Northern Institute for Cancer Research at Newcastle University, and a Consultant Haematologist at Newcastle’s Freeman Hospital, led the UK-wide study.

He said: “This is a major breakthrough as it shows that the long-term use of lenalidomide significantly improves the time myeloma patients stay in remission after initial therapy.

“It is a huge step and, importantly, identifies that for younger patients lenalidomide improves their overall survival for this difficult-to-treat bone marrow cancer.

“Our research highlights that lenalidomide should be considered for newly diagnosed patients following stem-cell transplantation.”

Study’s findings

The Myeloma XI seven-year study involved more than 4,000 patients in 110 hospitals in the UK and was funded primarily by Cancer Research UK, with support from Myeloma UK and a number of educational grants.

As part of the study, a total of 1,137 newly diagnosed patients were randomly assigned to lenalidomide maintenance therapy and 834 patients to observation - this was after they completed their initial treatment.

The results show that lenalidomide can prolong the average remission time by more than two years in younger patients and by well over a year in older, less fit patients. It reduced the risk of progression or death by more than 50% in both groups.

The trial was run through the Clinical Trials Research Unit at the University of Leeds and the research involved experts from hospitals around the UK.

Professor Gordon Cook, Clinical Director at the Leeds Institute of Clinical Trials Research at the University of Leeds, was a co-author of the paper and believes lenalidomide should be available on the NHS.

He said: "Our results confirm lenalidomide can significantly prolong the lives of people living with myeloma in the largest trial to date.

“This treatment is not yet available on the NHS for this group of patients and this represents an unmet need."

The results confirm the findings of three much smaller studies which showed that after stem-cell transplantation, lenalidomide reduces the risk of disease progression or death by 50% compared with placebo or no treatment.

Patient's story

Mother-of-one Sarah Williamson was given a shock diagnosis of myeloma three years ago.

The 41-year-old had suffered from back and shoulder pain for almost a year but believed it was a running injury and could never have imagined how her life would be turned upside down.

She had attended her doctors’ surgery multiple times, but it was not until a birthday hug from her husband fractured a rib, and she was unable to get out of bed one morning, that the seriousness of her condition became clear.

Hospital scans and tests revealed that she had myeloma and Sarah was put under the care of Professor Graham Jackson at the Freeman Hospital.

She joined the Myeloma XI study and was randomly selected to receive lenalidomide following chemotherapy and a stem-cell transplant.

Sarah, who is married to Richard, 39, and has daughter, Annecy, six, is currently in remission and has no sign of the bone marrow cancer in her body.

The communications executive, from Darlington, said: “It was devastating to be diagnosed with myeloma. I had a young child, my health was in a bad way and I couldn’t imagine feeling well again. 

“When I was asked if I wanted to be part of the clinical trial I didn’t hesitate to say ‘yes’ and I was delighted that I was randomly selected to get lenalidomide as I’ve responded very well to the drug.

“For patients to get an extra two years remission is fantastic and it’s what every person with the condition hopes for as it means they can get their life back to as normal as possible.

“I have hardly any side effects of the treatment and all my pain is gone. I feel lenalidomide should be available on the NHS.

“When I meet people who have the condition and are not on the trial I feel a sense of injustice on their behalf as taking this drug has helped me get my life back and I am enjoying it to the full.”

Sarah continues to be monitored by experts and gets regular check-ups and medical tests.

Reference

Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-lab, randomised, phase 3 trial

Graham H Jackson et al.

The Lancet Oncology.