Graham Jackson, MD
Lenalidomide (Revlimid) as a maintenance treatment for patients with newly diagnosed symptomatic multiple myeloma demonstrated encouraging phase III findings in the Myeloma X1 trial, which were presented at the 2016 ASH Annual Meeting.
In the multicenter, open-label, randomized, UK study, 1550 patients were randomized to receive maintenance lenalidomide or observation following maximum response or at 100 days after transplant.
Results showed that the lenalidomide maintenance therapy arm was associated with a 55% reduction in the risk of progression or death compared with the no maintenance arm (HR, 0.45; 95% CI, 0.39-0.52; P
<.0001). The median progression-free survival (PFS) was 37 versus 19 months for lenalidomide maintenance and no maintenance, respectively.
In an interview with OncLive
during the meeting, lead study author Graham Jackson, MD, professor, consultant hematologist, Newcastle Hospital, provides an overview of the study and the impact of maintenance therapy with lenalidomide on the landscape of multiple myeloma.
OncLive: Can you provide some background on this maintenance study?
: The Myeloma XI trial that we presented is a large phase III study conducted in over 100 centers in the UK. We recruited more than 4000 patients to the trial in its entirety. The data being presented are about lenalidomide maintenance, and examining patients who went through their treatment and responded. They were randomized on a 1:1 basis between lenalidomide maintenance and no maintenance treatment.
What were the primary results?
The findings of this study, in about 850 patients, is that lenalidomide—throughout all patient populations—increased the number of people staying in remission. The PFS across the whole cohort increased by about 22 months and, for the transplant-eligible patients, by nearly 28 months.
Even for the older population, the PFS increased by over 12 months. All patients, of all ages, benefited from the lenalidomide maintenance. The results really confirm the data that have been put together looking at the meta-analysis of lenalidomide maintenance. Our results really nicely integrate with this, showing that lenalidomide maintenance is now the standard of care for patients with myeloma in their first response.
What is the main takeaway from this study?
There is now a huge body of evidence across a large number of patients. There were 857 patients in our study who went on to receive lenalidomide maintenance. We have shown that it is safe, deliverable, and really prolongs remissions. It prolongs the remission of patients who are in a transplant-eligible group. It also prolongs the remission in those patients who are older, frailer, and are not eligible for transplant. It's an across-the-board benefit.
We have shown it’s safe. There were some questions about the instance of secondary malignancies in this group of patients, but we have also shown that this incidence of second primary malignancies is really not as significant as we first thought.
How was the adverse-event profile in this study?
Some main adverse events from lenalidomide maintenance are around hematological toxicity. The most common grade 3/4 toxicity was neutropenia. We didn't see a lot of infection and, on the whole, most patients seemed to tolerate the treatment very well. Of course, with lenalidomide maintenance, you can adjust the dose so the patient stays on the therapy without having to come off the drug because of toxicity.