Welcome to Managing Myeloma, I am Dr. Jacob Laubach. I would like to briefly review whether or not you should be concerned about second primary malignancies associated with lenalidomide maintenance in the transplant and non-transplant settings. In the post-transplant maintenance setting, two randomized clinical trials (the IFM 2005 and the CALGB 100-104 trials) demonstrated an increased risk of second primary malignancies in patients who received lenalidomide maintenance. The risk was 8% for those who had received lenalidomide, versus 4% for those who received placebo, essentially a doubling of the risk. It is notable that these cancers were both hematologic in nature and solid tumors. It is also important to note that in both of these trials, there was a progression-free survival benefit associated with the use of lenalidomide, and that in the CALGB 100-104 trial, there was a significant overall survival benefit.
It is very important for patients who have undergone transplant and are making a decision about whether to proceed with lenalidomide or other maintenance to understand the rationale for, as well as the risks associated with, maintenance therapy; second primary cancers in the case of lenalidomide, but also other potential risks. It has been my experience in the clinic that data on the risk of second primary cancers affects patients differently. Some patients are very concerned about the prospect of developing another cancer, even though they have a relatively low likelihood (8%) of developing such an issue. Others view this as an acceptable risk, recognizing the benefits conferred by the use of lenalidomide maintenance. At the end of the day, we make these decisions together; and if the patient cites significant concerns about the use of lenalidomide maintenance, we pursue other options. On the flipside, if patients view this as an acceptable level of risk, we proceed with lenalidomide maintenance. The key is to be working in conjunction as a team between the patient and the physician.