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Revlimid Maintenance Therapy Shows Improved Survival Rates Following Transplant

Posted on December 22 2009 by Pat Killingsworth | 13,357 views

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

4 Comments For This Post

  1. Jan Says:

    Interesting study. It raises some thoughts. I am in complete response from transplant. No maintenance therapy. Let say I relapse after four years(almost half way there now). So I go on revlimid then, and it controls my MM for another four years before I need a different treatment. Would not that treatment plan produce the same overall end result, with the bonus of four years of NO drugs? You can see where I am going with this…I want the treatment that gives me the most time off drugs and the lest side effects. As you have been reporting, there are new and exciting treatment options coming…and quality of life is a very big consideration for me. Revlimid is also much more toxic to the kidneys…which why it is so important that mm patients find a doctor that tailors their treatment to their individual disease and side effects. Keep reporting, and here my New Years wish that in a few short years we are talking about the cure…..we have the best and brightest working on that.

  2. Pat Killingsworth Says:

    Very logical, Jan! It is a chicken/egg thing, isn't it? That is why I have chosen to use my drugs and/or therapies one at a time. This includes SCT. When Revlimid stops working well for me on this dose, I will increase the dose–then add dex–then try Velcade–then a new combo–and maybe then, and only then–especially if my neuropathy is getting worse–will I go to transplant. Different choice than yours, but only different in the order I choose to get my therapy. Fascinating, isn't it? Good luck to you! I like the way you think in four year cycles! Pat

  3. Jerry Says:

    I agree with Jan. This study only looks at one result. Time to progression. What about quality of life. What about Jan's quality of life if she had been taking maintenance therapy for the last four years? Pat, you follow Nick's blog, what is his maintenance therapy doing to his quality of life?

    Also keep in mind who funded this study. Why did they only look at the one attribute where it would shine? What is the cost of Nick's three years of maintenance therapy?

    I think the clinical trial studies should just present the facts. Let the patient chose their therapy. I would rather have 5 years of a higher quality of life compared to 7 years of a lower quality of life. Another patient would rather have the 7 years. Every patient has different preferences. For a drug company to say the time to progression overrides everything else that they had to stop the trial so everyone could take their maintenance chemo doesn't quite sound right to me.

  4. Jan Says:

    I hope this doesn't sound wrong, but I am glad there are people willing to do the clinical trials like these. They will lead to a cure for many of us. One note, I have a friend that is on Revlimid, with out steriods, and he says he has no side affects, quality of life is good…just has to take something to prevent blood clots.
    I read that Nick has been fighting a rotten cold, like many of us. While I didn't undertake the same treatment as him, I am rooting for him and hoping his treatment kicks the beast out of his life for good. Jerry makes a good point that you need to understand the risks with any treatment you take, and don't ignore any side affects.
    Though not all of us are in clinical trials, I was able to release all my labs for use in a database for research, in fact, they take extra blood for special tests for hopefully that helps too.
    Merry Christmas to all…

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