Revlimid Maintenance Therapy Is Effective For Multiple Myeloma After Stem Cell Transplant (ASCO 2010)
Revlimid (lenalidomide) is an effective maintenance therapy after stem cell transplantation in multiple myeloma patients, according to two Phase 3 studies presented on Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO).
Based on the results of these two studies as well as a previous study, Revlimid maintenance therapy is likely to become a common addition to the treatment of myeloma.
Dr. Sergio Giralt of the MD Anderson Cancer Center in Houston led a discussion about these two studies during which he said, “[These are] two of the most important practice-changing presentations that have happened in myeloma over the last couple of years.”
The first study, which was conducted in the United States, found that Revlimid delayed time to disease progression. The second study, which was conducted in France, found that Revlimid extended progression-free survival.
United States CALGB 100104 Study
The U.S. study investigated whether maintenance therapy with Revlimid prolonged the time to progression (TTP) after single autologous stem cell transplantation.
Approximately 100 days after transplantation, patients who had at least stable disease were randomly assigned to receive either Revlimid or placebo until disease progression. Patients were initially given a dose of 10 mg of Revlimid per day. The dosage was increased to 15 mg/day after three months.
Initial results from December 2009 had indicated that Revlimid extends progression-free survival (see related Beacon news).
At ASCO, Dr. Philip McCarthy of Roswell Park Cancer Institute in Buffalo, New York presented updated results of the 568-patient study. “Maintenance therapy with Revlimid compared to placebo significantly prolongs time to progression,” reported Dr. McCarthy.
Dr. McCarthy and his colleagues found that 14 percent of patients on Revlimid had relapsed compared to 28 percent who received the placebo, putting Revlimid patients at a 58 percent lower risk of progressing than placebo patients.
The estimated median TTP for patients who received the placebo was 22.5 months. The median TTP for patients who received Revlimid has not yet been reached, indicating that Revlimid as a maintenance therapy significantly delays TTP.
After one year of observations, there is no difference in overall survival between the two groups. However, physicians are hopeful that longer follow-up will show a significant difference.
“We are obviously anxious to know if this longer remission will translate into improved survival,” said Dr. Brian Durie of Cedars Sinai in Los Angeles and the International Myeloma Foundation.
Although Revlimid maintenance delays progression, it appears to have a higher rate of serious side effects, including low white blood cells (42 percent versus 7 percent), low platelets (12 percent versus 3 percent), and low red blood cells (6 percent versus 1 percent). Dr. McCarthy said that the side effects were manageable.
In December 2009, due to the positive results, patients were notified about whether they were receiving Revlimid maintenance or placebo. Patients on placebo were allowed to choose whether they wanted to switch to Revlimid maintenance, and 87 percent have chosen to begin maintenance.
French IFM 2005-02 Study
A group of French researchers investigated Revlimid, molecularly similar to thalidomide (Thalomid), as maintenance treatment after they found that effective maintenance therapy with thalidomide was associated with peripheral neuropathy (numbness and tingling in the hands, arms, legs, and feet). Revlimid is not known to induce peripheral neuropathy.
Patients received short-term Revlimid (25 mg per day on days 1 to 21 in a 28-day cycle) for two months as consolidation therapy after autologous stem cell transplantation to help patients maintain remission. Patients were then randomly assigned to receive long-term, continuous, low-dose maintenance therapy with Revlimid (10 to 15 mg per day) or placebo until relapse.
Preliminary results from December 2009 showed that consolidation therapy with Revlimid helped more patients achieve complete remission than transplantation alone. Those results also indicated that maintenance therapy extended progression-free survival (see related Beacon news).
Dr. Michel Attal of the University Hospital in Toulouse, France presented at ASCO the updated results of the 614-patient study.
The researchers found that consolidation therapy with Revlimid improved responses in 20 percent of patients. More patients achieved complete responses and very good partial responses after consolidation. Likewise, a few additional patients achieved complete remission on maintenance therapy.
Additionally, maintenance therapy with Revlimid improved progression-free survival: 68 percent of patients on Revlimid had not progressed after three-years of maintenance therapy compared to 34 percent of patients who received the placebo.
The estimated median progression-free survival for patients who received the placebo was 24 months, while the median for the placebo group has not yet been reached
Dr. Attal and his colleagues found that patients benefited from Revlimid maintenance therapy regardless of whether or not they achieved a complete response after transplantation.
After three years of maintenance therapy, which is four years after diagnosis, overall survival was 80 percent for the placebo group and 88 percent for the maintenance group. However, the two rates are not significantly different. Dr. Attal said that 88 percent survival four years after diagnosis is “unprecedented.”
The rate of severe side effects in this study were all low, with low white blood cells being the most common (7 percent in the maintenance group, and 1 percent in the placebo group).
Attendees at the presentation were surprised that the rate of low white blood cells in this study was much lower than the rate in the U.S. study. Given the low rate, one attendee asked whether the French group would be studying a higher dose of Revlimid maintenance. However, Dr. Attal said that was not currently in their plans.
“What is most important about this study is that the benefit of Revlimid is seen regardless of response to transplant,” said Dr. Giralt.
Recommendations
Based on the results of these two studies, Dr. Giralt recommended that after transplantation, patients with residual disease as well as high-risk patients in remission should use Revlimid maintenance. Only in the case of patients with low tumor mass and low-risk disease is it unclear whether they should remain under careful observation or begin maintenance. For patients who are currently on thalidomide maintenance and responding well, they should continue with their current therapy.
For more information on the studies, visit abstract 8017 (U.S. study) and abstract 8018 (French study) at the ASCO meeting website.
Related Articles:
- Revlimid, Velcade, and Dexamethasone, Followed By Stem Cell Transplantation, Yields Deep Responses And Considerable Overall Survival In Newly Diagnosed Multiple Myeloma
- Sustained Complete Response To Initial Treatment Associated With Substantial Survival Benefit In Multiple Myeloma
- Selective Digestive Decontamination May Reduce Risk of Infection In Myeloma Patients Undergoing Autologous Stem Cell Transplants
- Stem Cell Transplantation May Be Underutilized In Multiple Myeloma Patients In Their 80s
- Latest Myeloma Research To Be Presented At The American Society Of Clinical Oncology Annual Meeting (ASCO 2018)
I have just undergone an autologous (using my own cells) stem cell transplant for bone marrow transplant. this was after 4 months of chemo to reduce myeloma cells. I am happy to report that 100 days pot transplant I am in full remission. Now the doc's want me to go on Revlimid at a 10 mg per day dose for "maintenance" I had very poor reaction and lots of neuropathy especially in my feet and legs. Not wanting this to get any worse I am leery of doing this. any thoughts?
I copied this report and I am sending it to my Hemotologist. I am in remission 5.5 years after auto SCT and not on maintenance.
I am on maintenance chemo of 10 mg of revlimid, post transplant. So far, have responded well to all treatments, and am in a complete remission. Have been taking the revlimid for five months now. Am suffering fatigue and dry mouth, but am trying to work around that to prolong my TTP. hAving met many other myeloma patients in our local support group, am only too aware that not everyone stays in remission. My oncologist is hoping to have me on the meds for a year at most.
MM stage III. IgG. Seven broken ribs and six compressed vertebreas. 3 levels of kyphoplasty done. In remission and I am choosing not to do the stem cell transplant because I believe this article. Doctors are not fighting me. They are real quiet when I mention the article. There seems to be that twilight zone feeling going on with no eye contact. They are not agreeing or disagreeing. I believe we are on a MM bubble. What will become of all the stem cell treatment centers if they are no longer needed? What about the jobs lost? I'm just saying........it may not be time to drive the kool-aide.......
After my ASCT there was still residual 0.1 MM which was disappointing. The numbers kept doubling for 9 months so my onc put me on 25mg. Rev/40mg Dex. I have no side effects & feel great. The cost is prohibitive but I am lucky to qualify for co-pay assistance which the Celgene rep helped me with. I don't know where this is taking me -- I can only focus on each day & how healthy I feel.
What did your hematologist say, Mike Baron? I'm between Auto SCT and beginning maintenance Revlimid 10 mg.
My husband had an ASCT last July which put him into full remission. The docs told him no maintenance therapy needed at this time.
I am 39 years old and had an ASTC 2 years 4 mos ago. I chose not to do maintenance and was in remission until last week when my Dr gave me the news that I have traces that have returned. I ha e decided to start maintenance therapy (10mg) daily. I will let you know how it goes.
Hi Melissa,
Iwas in CR for 4years after my asct. No maintenance, but aredia. It was great. I relapsed last summer, did 9cycles of rev/dex. After 5cycles my numbers were normal, but we did 4 more. I have now been off rev/dex 2 months. All still good, I get a blood test next month to check again.
It's difficult to relapse, emotionally, but you get thru. My doctor did start me on the 25 of dex, as it was his opinion to go bigger first. But lots of oncologist do start with the lower dose to see how you respond.
Also, my first 2 cycles with rev did not effect my m protein much, so when he added the dex,it went down very quickly.
Dex is hard to take, but I learned what to do on certain days.
Good luck, and best wishes.
Christina
Hi Everyone! I was on revlimid maintenance chemo for a year. It began 100 days after my SCT, which was in January 2010. The year was a little difficult at times, and had to take longer breaks between some of the cycles due to low neutrophil and WBC counts (i.e. low immunity). And I was getting a little emotional towards the end of it! The dose started at 10 mg, but after a few months, my oncologist lowered it to 5 mg, since it was really just maintenance, and I did have side effects besides the low immunity..including some pain in my feet. Three months after going off the chemo, I had a blood check up which showed everything to still be fine...in a CR right now. So, am still taking bisphonate treatment for my damaged bones, but now just check in every three months to make sure everything is going OK. The whole MM experience has been very nerve wracking, but seem to be doing well!
It's been 15 months since my ASCT. My Doctor put me on 10 mg of Revlimid as maintenance about 3 months after, and changed to 5 mg about 4 months ago. Been in partial remission the entire time until last month when I was told by my Doctor I was in full remission. I was given all my required vaccinations after 1 year post ASCT which I was told was standard. In November I will be getting another full body bone scan and an MRI along with the usual blood work and 24 hr Urine test. Although my Doctor feels I am doing very well she acted like it was just a matter of time before the MM would reappear. She said it could be a year or maybe even a few years, but she seemed pretty sure it was coming back. I'm not convinced that it has to come back, even though it does in most cases, but her feeling on the matter put a damper on what otherwise was a day of good news.
I am 1 month post SCT. It went very well, without complications. I am on a clinical trial and I got the arm that has tandem transplants with Revlimid maintenance for 3 years starting 3 months after my second transplant. My engraftment happened very quickly and my blood counts are normal! I am having a bone marrow biopsy next month to see what is happening with the MM. It should be interesting to see where I stand. Meanwhile, I will receive my second transplant in October.
I have been on revlimid for a year after an autologous stem cell transplant. The side effects are manageable.
I get very tired at night, joint pain, and some dizziness, yet I live a full rewarding life. Question: Does anyone
Out there have stomach issues from revlimid? I have Crohns , so it is hard to know if the worsening of my stomach
Symptoms is due to Crohns or revlimid.
Wini Engerman
Hi Winnifred, I did have stomach upsets after a few months on a low dose of Revlimid for 'maintenance chemo'. I would get intense vomiting, that could be controlled by anti-nausea meds, sort of a '24 hour flu'. Was unsure as to whether it was seasonal flu or drug side effects. This happened several times...haven't had it since went off Revlimid a few months ago though. That makes me think it was a side effect. Of course, my immunities were so low, that it could also have been repeated bouts of 'flu'...hard to say!!
Anyone out there on Revlamid who did not get any remission from ASCT ?? I am an RN-read the studies and neither addressed that issue.
I wrote last August, after my first Auto Transplant. I am now 4 months post second transplant. I am on a clinical trial. I take 10 mg of Revlimid every day. I do not any period that I do not take it. I will be increased to 15 mg at a later time. I am in CR. The study goes for 3-4 years. I have Neuropathy and stiffness and leg cramps. I tend to get tired fairly easily, but otherwise, I am doing very well. I am also getting Zometa for my bones, every month. My numbers have stayed pretty good so far. Who knows what the future holds, but try to keep a positive attitude every day! I am doing things that I enjoy and a lot of traveling (mostly cruises). I figure I should do what I can do, now, before I am unable to do what I want. Who knows when or if that will be. Meanwhile, most days, I forget that I even have cancer and some days, I have no doubt that I do. One day at a time is my mantra.
Thank you everyone for your comments. I am about to get a mm stem cell transplant. I am worried to death. So much information which is good but makes me nervous. I go for a biopsy to check % of cells the start collection. Then it's one day at a time. The doctor told me I've been on Revlimid to long!?! I'm a diabetic. I also have neuropathy from taking Thalidomide. Please share your experience regarding the collection of cells,transplant and after transpant effects. I am very interested.
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