Safety Concerns Force Withdrawal Of Revlimid Application For Expanded Use In Europe
Celgene, the company that markets Revlimid in the United States and internationally, announced this morning that it has withdrawn its application in Europe to have the drug approved for use as initial therapy for newly diagnosed myeloma patients as well as for maintenance therapy.
The company also is postponing until next year a similar application it had intended to file in 2012 with the U.S. Food and Drug Administration (FDA).
The European application was withdrawn due to concerns raised by regulators about the link between Revlimid (lenalidomide) and second cancers (also known as second primary malignancies).
Celgene's announcement came as a surprise to many observers -- so much so that Celgene's stock declined more than 11 percent today.
The announcement means that near-term European use of Revlimid in newly diagnosed patients will be noticeably less than previously expected. It also indicates that concerns about risks associated with Revlimid maintenance therapy are continuing to persist.
In both Europe and the United States, Revlimid's only officially approved use as a myeloma treatment is for patients who have received at least one previous therapy.
In the United States, however, the drug can legally be used "off label" to treat newly diagnosed myeloma patients, and it very often is. A recent Beacon survey of its readers -- a majority of whom live in the U.S. -- found that 45 percent of them received Revlimid as one of their initial myeloma therapies.
Restrictions on the off-label use of drugs in Europe, however, mean that newly diagnosed European myeloma patients are treated much less frequently with Revlimid
Revlimid also is not specifically approved to be used as maintenance therapy. Nevertheless, its use as maintenance therapy has increased in the U.S. since initial results from three clinical trials showed that such treatment nearly doubles time to relapse. One of the three trials also has shown an overall survival benefit to Revlimid maintenance therapy (see related Beacon news).
It is data from these three trials -- known as the MM-015, IFM, and CALGB studies -- upon which the European application for Revlimid's expanded use was based.
It is also these three studies that have shown that Revlimid maintenance therapy -- either after stem cell transplantation, or after melphalan (Alkeran)-prednisone-Revlimid initial therapy -- increases the risk of a myeloma patient developing second cancers.
Both U.S. and European regulators have carried out reviews of Revlimid's safety during the past year, focusing on the drug's link to second cancers. Neither review led to any restrictions being placed on Revlimid's use. Both reviews, though, led to additional warnings being added to Revlimid's official U.S. and European prescribing information (see related Beacon news about the U.S. and European investigations).
When it announced the end of its review of Revlimid's safety, the European Medicines Agency (EMA) said that it "has confirmed that the benefit-risk balance for Revlimid (lenalidomide) remains positive within its approved patient population," and it noted that "the benefits of Revlimid, particularly improved survival, continue to outweigh the risks."
Today's announcement by Celgene, however, makes clear that a key part of the above statement from the EMA is the text that reads ""within its approved patient population."
Although the EMA appears comfortable with Revlimid's benefit-risk profile when the drug is used to treat myeloma patients who have had one previous therapy, the agency apparently is less convinced of Revlimid's benefit-risk profile when the drug is used as maintenance therapy or to treat newly diagnosed patients.
Celgene issued a brief press release early this morning announcing its decision to withdraw Revlimid's European application and providing an update about pomalidomide's regulatory status in the United States and Europe (see related Beacon news).
Later in the morning, Celgene executives hosted a conference call to provide further information about the recent developments and answer questions about them.
In a prepared statement at the beginning of the call, Celgene Chief Executive Officer Robert Hugin said that “In response to the need for more follow-up and mature data from the MM-015, IFM, and CALGB studies to allow [European authorities] to reach a clear benefit-risk conclusion, we have withdrawn the Revlimid newly diagnosed multiple myeloma application."
Mr. Hugin added that, despite the withdrawal of the European application, Celgene is "proceeding with submissions for Revlimid in newly diagnosed multiple myeloma in Switzerland, Australia, and other core markets."
For more information, see the complete compilation of Beacon articles with information about the Revlimid safety controversy as well as the complete text (below) of Mr. Hugin’s statement about the withdrawal of Revlimid's European application.
Partial Text of Statement By Robert Hugin, Chief Executive Officer, Celgene Corporation
(made during publicly broadcast conference call, June 21, 2012)
In response to the need for more follow-up and mature data from the MM-015, IFM, and CALGB studies to allow the CHMP [Committee for Medicinal Products for Human Use] to reach a clear benefit-risk conclusion, we have withdrawn the Revlimid newly diagnosed multiple myeloma application. Our intention is to resubmit the application at the earliest possible time.
As we responded to each specific set of questions and discussed the progress of the application with our CHMP assessors, the 180-day questions made it clear that the follow-up and maturity of the studies with respect to the potential impact of second primary malignancies [SPMs] on the current survival trends had become a principle concern.
Based on these questions, we explored multiple approaches to more precisely define the positive benefit-risk ratio for Revlimid across the patient populations presented in our application.
Included in our responses were analyses that separated induction from maintenance indications and limited the potential approval to a subset of patients not eligible for stem cell transplant.
While there is strong consensus regarding the clinical benefits demonstrated by the studies in our application, discussions during and after our oral explanation further defined the need for additional follow-up to ensure that the current benefit-risk profile is not negatively impacted by SPMs.
We are proceeding with submissions for Revlimid in newly diagnosed multiple myeloma in Switzerland, Australia, and other core markets.
In the United States, we are currently reevaluating the timing and scope of our Revlimid newly diagnosed submission to the FDA and now anticipate submitting an application in 2013.
We are disappointed with this delay, but are very confident in the strength and importance of the data from these three trials, as evidenced by their recent publication in the New England Journal of Medicine.
These studies join the growing body of clinical evidence from a current total of seven completed Revlimid-based Phase 3 studies in multiple myeloma demonstrating positive patient benefits. In addition, there are approximately 15 ongoing Phase 3 trials evaluating Revlimid in combination with virtually every investigational drug in development for myeloma.
We are committed to ensuring the broadest access possible to Revlimid for myeloma patients around the world.
Related Articles:
- Nelfinavir Shows Only Limited Success In Overcoming Revlimid Resistance In Multiple Myeloma Patients
- FDA Approves Once-Weekly Dosing And Revised Safety Information For Kyprolis
- Revlimid, Velcade, and Dexamethasone, Followed By Stem Cell Transplantation, Yields Deep Responses And Considerable Overall Survival In Newly Diagnosed Multiple Myeloma
- Once-Weekly High-Dose Kyprolis Yields Deeper Responses And Longer Remissions Than Twice-Weekly Kyprolis (ASCO & EHA 2018)
- Two Darzalex Clinical Trials Halted; Little Impact Expected On Drug’s Use In Multiple Myeloma
I wonder how much money the EU saves by making this decision?
It'll be interesting to see if they find other "problems" with expensive therapies as they continue with their economic troubles. Just my lay persons thought.
The availability in Canada is the same...only after having one previous therapy. It is available in most provinces here. The fact that Revlimid is being used in combinations with other drugs for first line therapy seems to be mostly in the US. Elsewhere, it is available that way in clinical trials. Just out of curiosity, are there any countries at all where it is approved for front line therapy?
I have been on Revlimid as a front line therapy and continuously since March 2009 at the 10 mg level. I have had no side effects that I am aware of after over 3 years of use. I also have not had any issues with insurance coverage up to this point. I was given RVD as my initial treatment and still am on that combo and have maintained a remissive state. The Velcade was reduced to from once a week to once every 2 weeks and is not subcutaneous vs. the original infusion. The dex has been reduced from 40 mg a week to 20 mg every 2 weeks concurrent with the velcade. I also get an infusion of Aredia every 16 weeks down from every 8 weeks.
Ron
Angiogenesis inhibition with Imib medications like lenalidomide (Revlimid) remains the most important pharmaceutical option for current MM patients. While pomalidomide may be even better in this class eventually, for now lenalidomide remains the best maintenance therapy for most of us after initial induction therapy, with or without autologous stem cell transplant. I'm tolerating 10 mg daily without any definite side effects, and am hoping to be in remission on it for a long time before having to consider other therapeutic options. I'm still holding out hope for a permanent cure in the not too distant future though! May all enjoy our long summer days (at least in the northern hemisphere). Remember, today is the present....
Hi Jan and Ron, I realize that Revlimid is used 'off label', and 'on label' too I guess for treatments after the initial treatment, but I just find it curious that it hasn't been approved yet for first line treatment. The world of pharmaceuticals is not always straight forward, and no wonder we patients get confused about it sometimes! I would also contend, Jan, that the proteasomase inhibitors are very effective drugs, based on my personal experience. Velcade saved my life...that's my 'spin' on it! Whatever gets us better again has my vote, though!
Hi Nancy!
One of the things about getting an FDA approval for an 'indication" means you have to as the mfgr pay to prove that and apply for that 'first line' indication. If you are a mfgr, and clinicians are using your drug 'first line' what is the cost-benefit? It costs lots of money to design a trial and prove that, IOW's there is no cost upsides. Off label use is good for all patients..thank GOD ..doctors get to make that decision, even if mfgrs have not chosen to pay the costs to gain FDA approval for 'first line' IOW's using it 'off label' has nothing to do about efficacy and everything to do about what it will cost the mfgr to do those trials and gain approval. If as a patient you have questions about the lack of approval, ask questions.
Which is what I was trying to say when I said that the FDA approves one indication, and then the clinicians have access, outside of trials, to use their judgment as to when and how to use the drug. That is USA, not Europe, or other countries/continents, which pay for health care, where cost is the issue more so then efficacy.
I was really disappointed that some folks believed I was saying the FDA should ignore 'safety concerns' they don't. What they do is put it in the label and rely on physcian judgment. As you may recall, I emphasized that the FDA, as a regulatory body, had done that with lenalidomide regarding SPM. I said, that should not be regarded lightly. And it shouldn't. They have a duty to warn, and they did. Many people do not understand that big difference. But the FDA warnings should be taken very seriously especially if it results in a lable change. That is huge.
The US system of drug approval relies heavily on physician judgment, they give the warning and rely heavily on physicians to rely on their judgment as to when and how to use the drug. But we as patients need to also know those warnings/precautions and seek out answers from our physicians. The physciians can prescribe but it is ALSO our responsibility to weigh those risks and benefits AS PATIENTS, independent of what is recommended. That is what being informed means.
If we make that choice as INFORMED patienst, that is good...but we need to know what we are choosing.
That is my sole objective. KNOW the risks & benefits or your choices. Don't think you are choosing SCT, you aren't that is RESCUE from the HDT that is the therapy. ASK questions about HDT, know what can happen. AutoSCT is not therapy, it's salvage...so ask questions about what IS the therapy.
All of which is to say why I emphasize being INFORMED as a patient. It is our lives and our bodies, we bear the consequences or our choices. Not the physicians.
So yes! I feel all of us should do what we feel is the best for us...but know your choices and what it means.
Hi Suzie! Nice to hear from you...the Beacon seemed very quiet without your input, actually. I will ask around here but I think that if a drug is not approved for the first line of treatment then it is just not available for that. But since I am not being actively treated right now, am not in such close contact with the world of what is new in treatments. So in that regard a country with a universal health care system does not have the same flexibility of the system you have. The plus side of course is that we are all equally able to access the treatments. Hmmm...something to look into I guess. I will try to determine whether or not the combos mentioned here (RVD for example) are used for initial treatment...or maybe someone else knows about that? Just my curiosity again, since of course I have already had two lines of treatment plus the HDT/return of stem cells.
I have realized all along that HDT is meant just for that, to rather drastically clean out your marrow of any and all stem cells, and that the stem cells from your own collection are saved back to 'rescue ' your system. Is that also true for 'allo' transplants? Do you need to get the same amount of HDT, or is the 'mini allo' a lesser version of that? I think that I read here that the 'mini' allow use less of the melphalan type chemo (alkylating agents), and is popular with some patients also.
So it's a good idea to bat these ideas about and brain storm too, as much as is feasible. i guess the bottom line is to hope that we ALL get into a good remission and put this dread disease on the back burner indefinitely! I am OK again now, so am most grateful for that. I would not have been knowledgeable enough to produce my own 'treatment plan' and am still on a learning curve about myeloma.
I do not think extensive use of new drugs early in the treatment process does all that much to improve patient outcomes. Here is an interesting study done that shows the US and Europe as having fairly equal outcomes. This was the main point of the study:
"We designed a multicenter, retrospective study that enrolled 294 patients with relapsed MM, from 14 sites (122 from Europe, 107 from US, and 65 from Korea). Patients were refractory to Bz, defined as no response to prior Bz-containing regimen or disease progression within 60 days of a Bz-containing regimen. Patients were also relapsed, refractory, intolerant, and/or ineligible, to treatment with an IMiD (thalidomide or lenalidomide). The date patients satisfied the above entry criteria was defined as time zero (T0)."
"The mean (median, range) time to reaching T0 from diagnosis was 4.5 (4.0, 12.8), 4.2 (3.2, 18.6), and 3.2 (2.8, 9.6) years from diagnosis for patients from US, Europe and Korea, respectively, P=0.021. The mean (median, range) number of therapies for the three groups were 8 (8, 13), 4 (4, 10), 5 (4, 7), respectively; P=PR) to the initial therapy at diagnosis were 56%, 77% and 49% respectively for the US, European and Korean cohorts."
"The results of the current study demonstrate significant differences between different parts of the world in terms of the treatment patterns both in the setting of initial therapy as well as treatment of relapsed disease. Patients in the US were more likely to receive multiple regimens both before and after T0. This is likely a reflection of increasing numbers of new drugs that have gone into clinical trials and thus enhancing options. The study further highlights the poor outcome of patients who have relapsed after the new drugs, irrespective of the geographical location."
http://myeloma.org/ArticlePage.action?tabId=0&menuId=0&articleId=3572&aTab=-1&tBack=&tDisplayBack=true
It does not seem like patients in the US do much better than those in Europe. I would also note that Europe had patients go as long as 18.6 years before reaching T0 and the longest in the US was 12.8. Just using a lot of new drugs early in the process does not lead to significantly better outcomes according to this study.
Mark
I think the biggest problem with taking too many drugs too early is hindering the body's native immune system from helping to keep the disease in check.
I keep harping on the same observation -- but it is certainly noteworthy --that MGUS patients (who can have up to 3 gm M-protein/dL and significant bone marrow involvement (up to 10%) can nevertheless remain in a progression-free state for decades - if not their entire, full life.
And because the MGUS cutoffs are wholly arbitrary, it is also the case that some smoldering patients (who have greater that 3 gm M-protein/dL or greater than 10% bone marrow involvement) can also go for many years (if not more than a decade) without progression.
My point regarding active MM then is a philosophical one (by extrapolation): If initial treatment is directed to knocking back the disease to an MGUS/smoldering state, then maybe that is the way to go --if one embraces a more integrative approach.
And yes: I know this is a hot-button issue -- which I do not want to rehash.
Well, I guess my concern is that drugs that might have been used for patients for their initial treatment do not get into the 'pipeline' for approval after all. There are always clinical trials going on which can give some patients access to new or not-yet-approved drugs. I suppose that if we are lucky enough to have SOME treatments available, that at least will help a lot of the patients. Then if they do relapse, or do not respond within a set number of cycles, they can get the other drugs. There seem to be more drugs approved for relapsed patients. I am only generalizing though!
It is interesting about MGUS, isn't it? Anyone who gets their dx presenting with full blown stage 3 type myeloma can only guess as to how severe and for how long they had the MGUS! mUST have been for a few years though....maybe that's why being in total CR is not the only predictive indicator of success for a myeloma patient. If you can get along with MGUS for years, then I guess some patients can also muddle along with a low level of disease too. Obviously they do!
Nancy,
On your allo question. I've wondered why a patient would need any chemical therapy ahead of stem cell transplant. Since the idea is that the new immune system will seek out and destroy the MM cells (and hopefully not hurt other systems), why would a patient need chemo? I'm sure there's a reason though.
On your MGUS question..that's interesting. I guess that is the hardest part when evaluating length of life "with" myeloma. Most of us don't know how long we've already had it.
Not to be negative, but I wonder if the people who are still chugging along 18 years after diagnosis, were properly diagnosed in the first place? Haven't the criteria changed for diagnosis in the last 18 years?
Suzie--interesting information on FDA--thanks.
Nancy S, Stan,
Some type of preparation (chemo or radiation)is required before an allo transplant. Your immune system will not just allow another immune system to come in and take over if it is not weakened in some way. Just think back to when you did your Autos. It takes a week or so after they give you back your stem cells for them to graft. Donor cells will not be able to graft if your immune system is fighting them.
A very basic explanation of your immune system. It identifies things as "self" or "non-self" (foreign). In most cancers, Doctors will say the immune system has not identified the cancer as foreign. In Myeloma there is some evidence that your immune system identifies the myeloma as "self".
"The researchers found that immune-system cells known as plasmacytoid dendritic cells (pDCs) essentially assume a new identity in the presence of myeloma – promoting the growth and survival of malignant myeloma cells, helping them fend off drugs, and depleting the overall strength of the immune system."
""This is the first time that immune system cells have been found to be converted to another function," says Chauhan, who is also a principal associate in medicine at Harvard Medical School."
http://www.sciencedaily.com/releases/2009/10/091005123043.htm
Donor stem cells will be viewed as "non-self" by your immune system and your immune system would attack the Donor cells. The Donor cells would not engraft and you would end up with your immune system fighting off the Donor cells.
The reason Allos can cure patients is that the myeloma is foreign to the Donor immune system. Even with a perfectly matched Donor, there are some minor histocompatibility antigens that can kill the myeloma. The Donor cells are therapy after Allo transplant, unlike in the Auto setting where there is no difference between the immune system and the myeloma. Here is a basic explanation of the rationale of Allo transplant:
"From the view of clinical efficacy, allogeneic stem cell transplantation consists of two different therapeutic approaches, each capable of inducing marked cytotoxicity in myeloma patients: (1) high-dose chemotherapy and (2) immunotherapy mediated by immunocompetent donor T cells.
High-dose chemotherapy alone (supported by autologous stem cell transplantation) has become the standard treatment of patients up to the age of 65 years, but the long-term results are not satisfying because ultimately all patients will relapse, suggesting that chemotherapy given at its maximal tolerable dose is unlikely to eradicate all myeloma cells.9, 10 Evidence of a strong immunologically mediated anti-myeloma effect came from donor lymphocyte infusions (DLIs) given to patients who relapsed after allogeneic stem cell transplantation. Response rate (CR/partial remission (PR)) between 40 and 67% can be achieved, but these remissions are durable only in a minority of patients.11, 12 Therefore, the existing 'graft-versus-myeloma' effect is less potent than in other diseases such as chronic myeloid leukemia or chronic lymphocyte leukemia, suggesting that immunocompetent donor T cells alone are unlikely to be successful in eliminating all myeloma cells in patients with multiple myeloma. Despite the high efficacy of high-dose chemotherapy as well as of immunotherapy by immunocompetent donor T cells, each therapeutic approach alone seems to be insufficient to induce long-term freedom from disease, but the combination of both (allogeneic stem cell transplantation after standard conditioning regimen) induces long-term freedom from disease in about 30–40% of the patients.""
http://www.nature.com/leu/journal/v21/n9/full/2404775a.html
Alone HDT or the immunotherapy from the Donor T Cells are not capable of curing patients, but combined they can. The cure rate will be higher going forward as Doctors better understand how to utilize the immunotherapy of DLI's. Also, Revlimid works better in patients that do allos than those that do not. Revlimid enhances the Graft vs Myeloma effect.
"The comparison between Auto and Allo patients has shown a benefit in terms of PFS and OS in favor of Len administered after AlloHSCT. This observation supports the hypothesis that Len is synergistic with the GVM effect."
https://ash.confex.com/ash/2011/webprogram/Paper43648.html
Mark
Thanks Mark and Stan for your thoughts on these matters. The change from SMM to actual myeloma is when one would start counting how long one had had it but then a lot of us don't know the date of that happening. We are indeed fortunate if we at least find out in time for the myeloma to be halted, or at least significantly slowed down. And on Allo's Mark, I realize that they can be great treatment, but even with allo's, not all patients get the long term remission (30-40% you quoted) either. My hope is that because now we are getting the 'novel' agents as a first treatment, and for many of us, a transplant of either sort as well, and sometimes even maintenance chemo, that the combination of all those treatments will keep the myeloma at bay for a long time. Of course I will be really pleased if I can read studies a few years from now which show that we didn't need that much therapy! That would be just terrific, since there is a younger generation coming up too, and one would hope that because of all the research being done now, things will be improved yet again in a few more years! We are all involved with a changing field in medicine.
Hi Stan,
You write:
" I’ve wondered why a patient would need any chemical therapy ahead of stem cell transplant. Since the idea is that the new immune system will seek out and destroy the MM cells (and hopefully not hurt other systems), why would a patient need chemo?"
Interesting. Do you think that an autoSCT is a 'new immune system"? Perhaps, that is where your ponderance stems from?
An autoSCT is NOT a 'new immune system" they give back your same diseased cells. The HDT which preceeeds the SCT is the therapy. The purpose of that is to obliterate your marrow an HOPE that means when they give back your same diseased cells...that somehow, by obliterating your marrow you will have more normal then neoplastic cells.An auto SCT is NOT therapy. It is how they manage the adverse effects of the HDT.
you also write:
"Since the idea is that the new immune system will seek out and destroy the MM cells (and hopefully not hurt other systems), why would a patient need chemo? "
You only get a 'new immune system" with an ALLO SCT. You need chemo since that IS the therapy not your stem cells re-infused...that is re-infusion saves you from death. It is NOT therapy.
That entire HDT is based on the philosophy that they can burn up your marrow and all remaining diseased MM cells...not on the auto SCT...that is simply SALVAGE. It keeps you alive...it is not therapy.
It is a salvage procedure to save you from death from the HDT. That IS the therapy. Giving back the stem cells, saves you from those lethal doses, it does NOT give an 'new immune system". Patients need to understand the HDT is the therapy, the autoSCT is salvage...managing the adverse lethal effects of the true therapy..toxic lethal doses of melphalan...a SCT is not therapy. It is salvage.
Stan, I just might make you wealthy with all this FDA info ..or you at least will place better bets
if you don't shoot the messenger....
Thanks Mark. That is a great synopsis of the allo transplant. Since I have 4 brothers, I've always had this in the back of my mind as my Hail Mary. (its why I always remember their birthdays too-ha). I wrongly assumed that the current immune system of an MM patient was so damaged that the new immune system could win the battle. But it makes sense to wipe out system first to give the new immune system a head start.
Perhaps you know the answer to this...Do leukemia patients get allotransplants because they are safer for leukemia patients than MM patients, or is it because it is their only option?
Suzie--We have agreed to agree, several times in fact, that the chemo prior to transplant is doing the dirty work. In this case, I was only talking about the allo. But thanks anyway.
OT--is it a fact that in the autoSCT, the source of more MM cells is within the frozen stem cells that are reimplanted?
I had heard they originated from parts of the bone marrow where the chemo could not penetrate.
Stan,
I see from some of your other posts that you are a bit of a "Fast Money" trader. Just curious, do you use any technical analysis? I had a great day today. It has been really pronounced lately, but in the late afternoon on Thursdays the markets have been starting a move that is a counter trend to the rest of the week. I got long stock and gold ETF's Thursday afternoon. First thing I saw this AM was gold up $45 an ounce - I would have done backflips if I did not have 3 compression fractures in my back from the myeloma!
That is it for the trading portion of this post. I do not think that allos are more dangerous for myeloma patients if risk factors such as age and general health are factored in. I believe the average age at diagnosis is in the late 60's for most myeloma patients. Allos are not appropriate for patients in that age group. I do not think a 45 year old newly diagnosed myeloma patient has any more risk than a 45 year old AML patient. One of the reasons the non relapse was so high previously was that it was hard to get patients into CR before doing the allo. The ideal time to do an allo is in first remission.
Prior to the novel agents the allo was almost an "all or nothing" type of bet. Now with the novel agents, it is possible to get patients to a low tumor burden prior to transplant. I have mentioned before that as myeloma patients we have the perfect drug (Revlimid) for allo patients. It works better in allo patients. Revlimid is being tested in other blood cancers after allo. Revlimid does not have direct killing effects in the other cancers, but its ability to increase NK and T Cells is very helpful in the allo setting. Velcade is being used in allo transplants for all blood cancers as well. It is used to prevent GVHD and patients Donor immune systems reconstitute faster when using Velcade early in the allo process.
I think the myeloma doctors are missing a golden opportunity not discussing allo transplants with younger patients. I really think the number of younger patients that would be functionally cured would be in the 50% range like allos are for other blood cancers. Allos do not work very well when used after a patient has relapsed off an Auto:
"In a multivariate analysis, relapse after prior high-dose chemotherapy was the most significant risk factor for TRM (hazard ratio [HR], 2.80; 95% CI, 1.16–6.74; P = .02), relapse (HR, 4.14; 95% CI, 2.04–8.38; P < .001), event-free survival (HR, 3.11; 95% CI, 1.77–5.46; P < .001), and overall survival (HR, 2.69; 95% CI, 1.35–5.35; P = .005)."
"In a subgroup of patients with chemosensitivity and no relapse to prior high-dose chemotherapy who underwent transplantation with PBSCs (n = 46), the cumulative risk of nonrelapse mortality at 1 year was only 6% (95% CI, 1%–22%) for related (n = 34) and 8% (95% CI, 1%–54%) for unrelated (n = 12) donors."
http://www.bbmt.org/article/S1083-8791(04)00272-1/fulltext
That study was on patients in 1998 to 2002 in Europe. I think Europe is more advanced than we are here in the US with allos. I do not think non relapse mortality should be much of an issue in 2012 for newly diagnosed younger myeloma patients. That figure is comparable to the Total Therapy II trial. Figure B shows 8% as treatment related mortality and 6% as cause unknown (not myeloma related).
"As can be seen in this figure, treatment-related mortalities were not more pronounced during the intensive phases of TT2. Only 51 of 668 patients, or 7.6%, died as a result of treatment-related causes."
http://jco.ascopubs.org/content/29/5/e125.full
Mark
Hi Mark,
Sorry for late reply. I was on a MM info-free holiday!
I have no training whatsoever in financial stuff. I invest in my own business because I know what's going on. And I'm much better at farming than picking stocks. I keep 90% of my IRA money in EFT's and then play with the 10%. And half of that, I have in MM related stocks because it seems like good karma-ha.
Thanks for the run down on Allo transplants. I will always wonder if I should have gone that route. My specialist was so adamantly against it, that he got a little short with me when I asked him for the third time. He said "Hey...let's go upstairs right now. I'll show you some patients who's only option was an allo" So, I don't know what to think. I just finished tandem and not so sure it was a good idea.
Stan,
The strategy I mentioned above worked again today. I have been a trader since I graduated from college. Maybe that explains my being so willing to do an allo - I am a gambling man! That is great that you own your own business. I have so much respect for people that own a business. You represent what capitalism is all about.
Our experience with our Doctors different opinions shows why it is so difficult to be a myeloma patient. There is no right therapy choice and every Doctor seems to have a different opinion. Fortunately there are examples of great outcomes with many different therapy choices. Time for me to go and close up shop for the weekend!
Mark
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