A number oncologists at larger cancer centers, which specialize in treating multiple myeloma, often choose not to place their patients on maintenance therapy following a stem cell transplant. As a matter of fact, a life without meds for a number of months following transplant has been one of the compelling arguments used to help convince patients to proceed to transplant. Other myeloma docs recommend their post-transplant patients stay on lower, maintenance doses of Revlimid, Velcade or both after a successful transplant.
My wife Pattie and I have used the prospect of maintenance therapy as an argument to delay transplant. After all, if you are going to need to continue taking the same drugs you were using prior to transplant–and if these same drugs are still working on their own–why get a transplant at all? Here is the first large, independent study showing Revlimid does indeed delay disease progression in patients who use the drug for maintenance therapy following a stem cell transplant:
Initial results from a large, randomized clinical trial for patients with multiple myeloma, a cancer of the blood and bone marrow, showed that patients who received the oral drug lenalidomide (Revlimid, also known as CC-5013) following a blood stem cell transplant had their cancer kept in check longer than patients who received a placebo. The clinical trial, for patients ages 18 to 70, was sponsored by the National Cancer Institute (NCI), and conducted by a network of researchers led by the Cancer and Leukemia Group B (CALGB) in collaboration with the Eastern Cooperative Oncology Group (ECOG) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The BMT CTN is co-sponsored by NCI and the National Heart, Lung, and Blood Institute (NHLBI), both parts of the National Institutes of Health.
The independent data and safety monitoring committee overseeing the trial (known as CALGB-100104) found that the study demonstrated a longer time before the cancer progressed following autologous blood stem cell transplantation for those patients on the study drug than those on placebo and so the trial was stopped early. Autologous blood stem cell transplantation is a procedure in which a patient’s own blood stem cells are removed, the patient is then treated with high doses of chemotherapy and/or radiation therapy to kill the cancer, after which the blood stem cells are returned to the patient. It is a common procedure for patients with multiple myeloma.
A total of 568 patients with multiple myeloma, who had received no more than 12 months of prior therapy and no prior transplant, were enrolled between December 2004 and July 2009. All patients received autologous transplantation following a high dose of a drug called melphalan, which is commonly used to treat multiple myeloma. Ultimately, 460 patients who had adequate organ function and no evidence of progressive disease, were randomized between 90 and 100 days after transplant to receive lenalidomide or placebo. Patients began lenalidomide or placebo between day 100 to 110 and continued until they had evidence of progressive disease.
Among the patients who received placebo, half had their myeloma progress (worsen) within an estimated 778 days. In contrast, for those patients taking lenalidomide, a median time to progression cannot be defined because fewer than half the patients had worsening of their myeloma. This represents a 58 percent reduction in the risk of disease progression for the group taking lenalidomide. This difference in time to progression was highly statistically significant.
This is the first randomized phase 3 trial (the final and most comprehensive aspect of a three-phase clinical trials process) to demonstrate a clinical benefit of lenalidomide following transplant for multiple myeloma. However, the trial has not yet shown evidence of an overall survival benefit.
The types of side effects observed in this trial were similar to those observed in other clinical trials with lenalidomide. Detailed results from this trial will be presented at a future scientific meeting.
“This study answers the important question for multiple myeloma patients regarding maintenance lenalidomide therapy starting at 100 days following transplant,” said Philip L. McCarthy, Jr., M.D., associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study. “We now know that prolonged maintenance therapy with lenalidomide when compared to placebo will delay disease progression. This is an exciting advance in the field of multiple myeloma therapy and occurred due to the willingness of multiple myeloma patients to participate in this study and to the cooperation of the many physicians and study groups involved.”
Good news, right? Yes! It is great to finally get a hold of some concrete data helping to prove or disprove the wisdom of using maintenance therapy following transplant. Looks like mainenance therapy advocates are beginning to win their argument! How does this effect my personal plan to delay transplant until the last possible moment? It doesn’t! In fact, this data strengthens my argument for delaying transplant. Next I hope researchers can produce data concerning whether it is OK to stop using Revlimid or Velcade after you receive a novel therapy induced complete response or remission (CR), or whether it is best to continue using that drug as maintenance therapy following CR. My guess is the outcomes will be similar, which is why my myeloma docs and I have decided to continue using Revlimid monthly.
Feel good and keep smiling! I am–my Revlimid is still working! Pat