Dr. Peter Voorhees from the Lineberger Comprehensive Cancer Center in Chapel Hill, North Carolina, presented these results at the 2011 American Society of Hematology (ASH) conference in San Diego last month.

Although Dr. Voorhees and his colleagues concluded that the combination of siltuximab and dexamethasone was well tolerated, Dr. Craig Hofmeister from the Ohio State University College of Medicine described the combination as a “toxic regimen.”

Dr. Hofmeister, who was not involved with the study, cautioned that siltuximab and similar drugs predispose patients to infection.  In this particular trial, 4 percent of patients died due to infections.  He also indicated that siltuximab has yet to demonstrate anti-myeloma activity that outweighs harm, although he stated that it was unclear whether siltuximab or high-dose dexamethasone was responsible for the serious side effects observed in this trial.

Siltuximab is a compound that blocks the activity of IL-6, a protein that facilitates myeloma cell growth and resistance to dexamethasone (Decadron). It is being developed by Janssen Biotech, a Johnson & Johnson company (NYSE: JNJ), and has been investigated for the treatment of prostate cancer, ovarian cancer, metastatic renal cell cancer, and Castleman’s disease (the overgrowth of lymphatic cells). Siltuximab in combination with Velcade (bortezomib), dexamethasone, or melphalan (Alkeran) has demonstrated anti-myeloma activity in preclinical trials.

In this Phase 2 study, researchers investigated the combined effects of siltuximab and dexamethasone for the treatment of relapsed and/or refractory multiple myeloma.

The trial included 53 heavily pretreated myeloma patients; however, only 49 patients were treated with siltuximab plus dexamethasone and were included in the analyses.

Prior to the start of the trial, the participants had been treated with a median of four lines of therapy.  All had previously been treated with Velcade and a steroid; almost all had previously received an immunomodulatory agent – such as Revlimid (lenalidomide) or thalidomide (Thalomid) – and an alkylating agent – such as melphalan; and two-thirds underwent an autologous stem cell transplant.

Eighty-six percent of the participants were resistant to their last therapeutic regimen.  Of the 44 patients with prior exposure to dexamethasone, 73 percent were resistant to their last dexamethasone-containing regimen.

The first 14 patients enrolled in the study received 6 mg/kg of siltuximab intravenously on days 1 and 15 of a 28-day cycle. After one or two cycles, 10 of these patients added 40 mg of dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 due to progressive disease or a low response. The remaining 39 patients received siltuximab and dexamethasone each cycle, since none of the first 14 patients achieved at least a partial response with siltuximab monotherapy.

Patients remained on this treatment regimen for a median of four cycles. Of the 47 patients evaluated, 17 percent achieved a partial response, and 6 percent demonstrated a minimal response. Out of the patients who reached at least a minimal response, two-thirds were not able to achieve a minimal response with a previous dexamethasone-containing regimen.

The median duration of response was 5.9 months, with three patients maintaining their responses for more than 9 months. The overall median progression-free survival time was 3.7 months, and the median overall survival time was 20.4 months.

Seventy-four percent of the patients experienced severe to life-threatening side effects, including low platelet counts (12 percent), fatigue (8 percent), abnormal liver function (8 percent), pneumonia (6 percent), low white blood cell counts (4 percent), and anemia (2 percent).

Twenty-five percent of the patients discontinued treatment due to side effects, and 10 percent of patients died during the study due to progressive disease or infection.

For more information, see abstract 3971 on the ASH 2011 meeting website.

One thing is for sure:  I don’t recover from sicknesses nearly as well as I used to before my autologous stem cell transplant in July.

Three weeks ago I experienced the worst cold I have had in a decade.  I was able to fight it off in a week or so, but then I was hospitalized this weekend with neutropenia (low white blood cell counts) and a fever of 102.4 degrees.

I’m home and feeling much better now.  But apparently a lower gastrointestinal bug and my last Velcade (bortezomib) infusion didn’t mix.

My old immune system was so tough.  Ten years as a teacher and coach and a healthy lifestyle meant I literally never got sick.

Of course, these are all just minor inconveniences, which would be much easier to take if my transplant had worked…

Which brings me to the point of this month’s column.

I’m learning that living with multiple myeloma is a lot tougher mentally than physically.

I can put up with nurses who can’t start IVs, weekend hospital stays, and bad colds.  But it’s the mental aspect of all of this that is even more demanding.

Keeping one’s head on straight should be something that we all work on daily.

Whether you chose yoga, long walks along a river, playing bridge with friends, or a hobby like photography, we all need to step back, take a deep breath, and immerse ourselves in something other than our cancer.

As readers constantly try to remind me, we all need to take a “myeloma break” regularly or this thing will eat us up and bring us down.

And I was down a bit this weekend.  After a bit of self-reflection, it didn’t take me long to realize that my failed transplant and my myeloma’s growing resistance to Revlimid (lenalidomide) has left me feeling vulnerable.

Talking about it helps.  But I’m not really comfortable discussing this with my wife and caregiver, Pattie.  It may be a mistake to try and protect her, but she doesn’t need to deal with all of this.  God, I worry so much about her and what she will do after I’m gone.

I’m guessing many of you also keep things from your caregivers on occasion.  Another shared experience that I will likely write about soon.

Thanks for listening!  I feel so much better!

Until next month, feel good and keep smiling!  Pat

In their statement, the experts reviewed the main findings from previous clinical trials that investigated the impact of maintenance therapies containing the novel agents thalidomide (Thalomid), Revlimid (lenalidomide), and Velcade (bortezomib).

Maintenance therapy is a prolonged, and often low-dose, form of treatment given to myeloma patients after their initial therapy. The goal of maintenance therapy is to prevent disease progression for as long as possible while maintaining a favorable quality of life. Maintenance therapy is different from consolidation therapy, which usually involves a shorter course of treatment with the goal of deepening patients’ responses to the initial therapy.

Based on these results, the experts came to the following conclusions for myeloma patients considering maintenance therapy:

The experts did not come to a consensus on the use of Revlimid as maintenance therapy. Revlimid maintenance increased progression-free survival in younger patients, which according to some experts speaks in favor of using Revlimid maintenance. However, Revlimid maintenance was also associated with an increased risk of secondary cancers, which according to some experts cannot be neglected when deciding whether to use Revlimid maintenance. The experts, therefore, said that longer-term survival data is needed before they can make a recommendation in favor, or against, Revlimid maintenance.

The experts stated that thalidomide maintenance is a treatment option for younger patients after stem cell transplantation, since thalidomide maintenance is associated with an increase in progression-free survival. For older patients who are not candidates for stem cell transplantation, the use of thalidomide maintenance is less clear because trial results were mixed in this patient population.

According to the experts, there is currently insufficient evidence available to make specific recommendations for, or against, Velcade maintenance therapy.

Additionally, the experts did not recommend maintenance therapy with interferons or corticosteroids alone.

Revlimid

Summary:

The experts found that Revlimid maintenance is associated with a significant increase in progression-free survival in both younger patients undergoing stem cell transplantation as well as older patients receiving conventional chemotherapy. Results of one study also showed a significant survival benefit with Revlimid maintenance therapy. However, the experts acknowledged that myeloma patients with high-risk chromosomal abnormalities do not benefit from Revlimid maintenance.

However, the experts pointed out that Revlimid maintenance therapy may be associated with an increased risk of secondary cancers (see related Beacon news), which they recommended physicians should bear in mind when deciding whether to prescribe Revlimid maintenance.

If the decision is made to use Revlimid maintenance therapy, the experts recommended a starting dose of 10 mg per day for both younger and elderly standard-risk patients. They added that both continuous therapy, as well as a “three weeks on, one week off” approach, may be effective.

Additional Information:

Results of two clinical trials, the United States CALGB 100104 trial and the French IFM 2005-02 trial, suggest that Revlimid maintenance may be effective in younger, standard-risk myeloma patients who received a stem cell transplant (see related Beacon news).

Results of the CALGB 100104 trial showed that after a median follow-up of 28 months, the median time to disease progression was significantly longer for patients who received Revlimid maintenance than for patients who received a placebo (48 months versus 31 months).

Patients who received Revlimid maintenance also had a significantly longer event-free survival than patients who received a placebo (42 months versus 22 months).

However, they also experienced more cases of low white blood cell counts, low red blood cell counts, low platelet counts, and infections.

Results of the IFM 2005-02 trial showed that after a median follow-up of 36 months, the median progression-free survival was significantly longer in patients who received Revlimid maintenance (41 months versus 24 months). However, the progression-free survival and overall survival were shorter in patients who had high-risk chromosomal abnormalities.

According to the authors of the review, a notable result of both the CALGB 100104 and IFM 2005-02 trials was the increased occurrence of secondary cancers among patients who received Revlimid maintenance.

Last year, after months of controversy over the apparent increase of secondary cancers among myeloma patients receiving Revlimid maintenance, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) began safety reviews of Revlimid. The EMA concluded that the benefits of Revlimid continue to outweigh its risks. However, the agency also recommended that the prescribing information for Revlimid be updated with a warning about the risk of new cancers (see related Beacon news).  The FDA investigation is still ongoing.

The experts commented that further studies are needed to evaluate the true risk of secondary cancers to identify risk factors and to develop strategies for their prevention in myeloma patients. According to the experts, “physicians and patients must weigh the benefits of Revlimid maintenance therapy against the low but relevant risk of secondary cancers.”

In addition to the CALGB 100104 and IFM 2005-02 trials, results of an Italian study indicated that Revlimid maintenance also prolongs the progression-free survival of elderly myeloma patients treated with conventional chemotherapy (31 months versus 13 months).

Thalidomide

Summary:

The experts found that thalidomide maintenance after stem cell transplantation may increase progression-free survival and, to a lesser degree, overall survival. However, they pointed out that patients with high-risk chromosomal abnormalities did not benefit from thalidomide maintenance.

The experts added that the lowest active dose of thalidomide is 50 mg per day and that the duration of thalidomide therapy should be limited to one year in order the limit the risk of severe side effects.

For older patients who are not candidates for stem cell transplantation, the experts pointed out that the use of thalidomide maintenance is less clear because trial results were mixed in this patient population.

Additional Information:

Studies of thalidomide maintenance therapy have been primarily in younger patients receiving a stem cell transplant.

In a small number of clinical trials investigating the impact of thalidomide maintenance in elderly patients, roughly half of the patients had been exposed to thalidomide during initial therapy. Results of these trials showed a significant increase in progression-free survival, but not overall survival, in elderly patients treated with thalidomide maintenance (see related Beacon news).

However, the experts were unable to confirm whether elderly patients who had not received thalidomide during initial therapy would benefit more from thalidomide maintenance than patients who had previously received thalidomide.

They indicated that thalidomide maintenance may be a valuable option in standard-risk elderly patients, although elderly patients may not tolerate thalidomide as well as younger patients.

According to the experts, most clinical trials have shown that thalidomide maintenance increases the quality of response and prolongs the progression-free survival of younger myeloma patients (see related Beacon news 1, 2, and 3). Additionally, these trials indicate that the risk for disease progression is similar in patients who received thalidomide during both their maintenance and initial phases and in patients who received thalidomide during their maintenance phase only.

However, the impact of thalidomide maintenance on overall survival rates is not as clear. While some studies indicate that thalidomide maintenance increases overall survival, other studies have shown that thalidomide maintenance fails to provide an overall survival benefit (see related Beacon news).

Therefore, the experts stated that the improved overall survival associated with thalidomide maintenance, as demonstrated in some studies, must be interpreted with caution.

They speculated that the most common explanation for the difference in overall survival rates across studies is the inclusion of elderly patients in some of the thalidomide maintenance trials that showed no improvement in overall survival. Moreover, they commented that differences in the availability of novel agents at relapse across studies may have also contributed to the different overall survival rates of myeloma patients receiving thalidomide maintenance.

In addition, the results of several clinical trials suggest that patients without high-risk chromosomal abnormalities are more likely to benefit from thalidomide maintenance than patients with high-risk factors.

For instance, in the MRC Myeloma IX trial, myeloma patients receiving thalidomide maintenance who did not have high-risk chromosomal abnormalities had a significantly better overall survival than patients who had chromosomal abnormalities.

Velcade

Summary:

The experts acknowledged that specific recommendations cannot be made for Velcade maintenance therapy at the present time because more information is needed regarding the optimal scheduling, dosing, and duration of Velcade maintenance.

They proposed further studies involving patients not previously exposed to Velcade in order to address these issues.

Additional Information:

According to the experts, single-agent Velcade maintenance therapies have only been investigated in myeloma patients who had already received Velcade during initial therapy.

For instance, the HOVON/GMMG clinical trial compared the effectiveness of a Velcade-doxorubicin (Adriamycin)-dexamethasone (Decadron) initial therapy followed by Velcade maintenance (PAD/Velcade) with a vincristine-doxorubicin-dexamethasone initial therapy followed by thalidomide maintenance (VAD/thalidomide).

After 36 months, patients who received PAD/Velcade had significantly better progression-free survival (78 percent versus 48 percent) and overall survival (71 percent versus 42 percent) rates compared to patients who received VAD/thalidomide.

Although the results of the HOVON/GMMG trial showed that Velcade maintenance therapy can be tolerated for up to two years, the experts claimed that the design of the study does not allow for a clear interpretation of the role of Velcade maintenance therapy because patients received different initial therapies.

Other studies have assessed the impact of Velcade maintenance in combination with thalidomide. Two of these studies indicated that Velcade plus thalidomide increases progression-free survival when administered as maintenance therapy.

Chemotherapy, Interferon, And Corticosteroids

Summary:

The results of previous clinical trials have suggested that conventional chemotherapy – melphalan (Alkeran) or BCNU (carmustine) typically used in combination with prednisone – prolongs the duration of remission in myeloma patients initially treated with melphalan plus prednisone. However, the experts pointed out that the use of chemotherapy in maintenance strategies was not pursued further when it was determined that chemotherapy failed to improve overall survival.

Interferon has also been shown to increase the duration of remission in myeloma patients, although results across studies have been mixed. According to the experts, physicians have abandoned the use of interferon in maintenance therapies because of toxicities and the inability to adequately select patients who are likely to benefit from interferon therapy.

Corticosteroids such as prednisone and dexamethasone have also yielded mixed results across studies. While prednisone has been shown to increase remission duration and survival, dexamethasone has been shown to lack benefit in myeloma patients. Taken together, the experts stated that the current data is insufficient to recommend corticosteroid maintenance therapy in myeloma patients.

For more information, please see the IMW consensus statement in the journal Blood (abstract).

But suffice it to say that lately there has been a lot going on with me, and it has brought to the forefront that inevitable discussion about what to do next should my current treatment regimen of Revlimid (lenalidomide) and dexamethasone (Decadron) start to fail.

I’ve discussed this prospect at various times over the past year with the handful of myeloma doctors who treat me as well as with other myeloma doctors I know.  They are unanimous that the next best thing for me would be a drug in the pipeline called carfilzomib.

The book on this new drug is that it is pretty effective and well tolerated.

The myeloma doctors I know talk about carfilzomib’s efficacy and especially about the fact that side effects seem to be relatively few and less onerous than with many treatment options.

I’d say that carfilzomib is one of the most highly anticipated new treatment drugs for myeloma – right up there with the introduction of Velcade (bortezomib) and Revlimid a few years ago.

Carfilzomib, however, is having a bit of trouble getting to the marketplace.

In December, I was watching NBC’s Nightly News when there was an item stating that the U.S. Food and Drug Administration (FDA) announced that it was not going to use the expedited approval process for carfilzomib – that it “did not see the urgency.”

In one of those talking-to-an-inanimate-object moments, I started shaking my hand at my TV and at either Lester Holt or Brian Williams (I was too distraught at the time to remember now which one) saying things like:

                        “Wait a minute, who says there’s no urgency?”

                        “I’m a myeloma patient – I’ll bet there are a lot more who think there’s an urgency here.”

                        “It’s urgent to me!”

So, instead of being approved – if it even gets approved – by this March, the FDA won’t reach a conclusion on carfilzomib until July 27 through the standard review process.

Not getting expedited approval was a surprise to just about everybody – even Wall Street analysts.  All the myeloma doctors I spoke with in the past year told me that they expected carfilzomib to be approved right after the first of the year.  Not so, now that the FDA has spoken.

It’s been a bumpy ride for this drug.

The first significant problem happened in the fall of 2010 when Onyx Pharmaceuticals, the company developing carfilzomib, moved from clinical to commercial-scale manufacturing, which resulted in “minor variations.”  This required fixing, of course, and an FDA review, forcing delay in the plan to file a New Drug Application by the end of 2010.

Another problem is that research supporting carfilzomib is only an open label, single-arm Phase 2b clinical study.  In a single-arm study, patients are managed with a specific therapy, and a proposed drug is systematically observed to measure outcomes among patients with the specific disease.  Participants are not randomized to receive either the study drug or the standard treatment, so no direct comparison can be made.

Pretty much everything I read in researching this column says that the FDA’s Oncology Drug Advisory Committee really prefers Phase 3 trial results.  Nonetheless, the FDA has given new drugs approval based on Phase 2 research on several occasions.

One of the things that Onyx did last year was gather additional safety data from other carfilzomib studies that are underway, which were included in the New Drug Application that was finally submitted at the end of last September.

The good news is that the FDA accepted the application in late November.  In its filing communication letter two weeks later, one of the review concerns raised by the FDA in accepting the application, however, was whether there was appropriate balance between risk and benefit.

The letter also included the bad news:  The FDA said no to a priority review.

In order to get priority review, it’s important to show significant benefit and a high degree of unmet need, especially when the supporting study is a single-arm Phase 2 trial.

So I guess what the FDA is saying is that while the results of the study show respectable benefit, they aren’t spectacular, and that those of us who are relapsed/refractory have a number of other treatment options that work.

Well, for many people that’s likely true, but for others, maybe not so.

You can get carfilzomib today under two conditions.  One is through a clinical trial, which means you can only get it at treatment centers participating in the study.

For me, if the time comes when switching treatment makes sense, it wouldn’t be too bad to enter a trial – under normal circumstances.  I’d have to be at Memorial Sloan-Kettering Cancer Center two days a week.  Since I work in New York City, that’s pretty much a no-brainer.  Heck, lots of myeloma patients have packed up and moved temporarily to another location for months in order to participate in a clinical study.

Unfortunately, if that “time” to switch is neigh upon me, my circumstances right now aren’t “normal.”  I’m sort of under indefinite house arrest with a broken foot, and home is almost 200 miles away from Memorial Sloan-Kettering.  Everyone there feels that trying to make that trip frequently would likely wreck any healing that’s going on with my broken bone.

You can also access carfilzomib as a last-ditch “salvage therapy.”  The Carfilzomib Myeloma Access Program (C-MAP), a joint undertaking of Onyx and the Multiple Myeloma Research Foundation, makes carfilzomib available to seriously ill myeloma patients in the U.S. lacking any other treatment options.

As for the prospects of carfilzomib winning approval this summer, the jury is still out. One Wall Street analyst pegs approval chances at around 80 percent.  Others aren’t quite so sure, seeing the failure to win priority review as a red flag.  And these Wall Street guys aren’t ignorant about things, especially new drugs, because there’s oodles of money to be made by those who get in early in pharmaceutical developments.  If you want to know what’s going on with a drug that’s under development, check with the Wall Street guys – reporters and analysts.  They pretty much deal with the cold, hard facts.

If carfilzomib doesn’t get approval, Onyx would have to submit a new application supported by a Phase 3 study; the main one underway is called “Aspire.”  It would move up a prospective launch to sometime in 2014, at the earliest.

Okay, just let me say that this all doesn’t seem right to me.

I know that the safety-benefit issue is important, and I have heard a few anecdotal reports of individual problems with carfilzomib.  But a handful of serious problems accompanying most any drug out there seems to be a matter of course today – just listen to the disclaimers on those incessant pharmaceutical ads on television.

I think the key matter here is that, as best I can tell, the benefit of this drug is clear.

It works.  Not for everyone.  Maybe not spectacularly.  But the key thing is: carfilzomib is effective.

The fact is, and we all know it, there’s no cure for myeloma.  And no single treatment works forever.

We need in the arsenal every possible and practical drug intervention to keep us alive.

I think the failure to give priority review to carfilzomib, and an FDA decision that the drug’s Phase 2 study is insufficient for approval, would deny myeloma patients an apparently effective and overall safe treatment option.

Carfilzomib is the wrong drug for the FDA’s Oncology Drug Advisory Committee to use just to make a point about Phase 2 research.

I think that doing so would be unconscionable.

Forcing relapsed myeloma patients to continue to wait for the wide availability of carfilzomib – perhaps another two years or more depending on how this drama plays out – would be just plain wrongheaded.

However, the very best news of the last seven days was the news of my sister Deana’s remission.

So many friends on the multiple myeloma journey have said that you’ll never forget the day you were told you were in remission.  I doubt we ever will – January 25, 2012.

Just nine weeks after Deana’s stem cell transplant and nine months after her initial diagnosis, we have this demon where we want it.  I truly feel that my birthday gift was delivered a week early – I could not think of anything I desired more.

The battle is far from over, though.  As we all know, our efforts must continue until a cure is found.

While my other sister Darrie and I were whooping it up at the news of remission and Deana’s husband Chris had a look of relief on his face, Deana remained a bit skeptical.

Deana read the report indicating a low level presence of myeloma and felt a bit discouraged.  We quickly reminded her that since there is no cure at present, there will always be a low level presence in her blood – but a low level is what we want…and need.

Deana’s oncologist Dr. Agha recommended maintenance therapy, which Deana had not been in support of when it had been previously discussed.  She wants to be done with this and definitely does not want to take any more pills.

As Dr. Agha laid out his reasoning for this recommendation, Deana was either swayed or knew that we’d pressure her to at least give it a try.

The maintenance therapy will be 10 mg of Revlimid (lenalidomide), three weeks on, one week off.  She’ll also take dexamethasone (Decadron), which we assured her is going to make her really buff.

We are set to see Dr. Agha again on March 7.

In the six weeks until our next appointment, I plan to research this particular maintenance therapy extensively.  Dr. Agha seemed surprised at my lack of questions on Wednesday, but I had decided to adopt the wait-and-see approach.  It didn’t seem sensible to prepare a litany of questions for outcomes and next steps that were unknown.

Fortunately, there’s a teleconference on Thursday, February 2, to review the key findings of December’s American Society of Hematology (ASH) meeting.  It is my understanding that Revlimid maintenance was discussed in detail at ASH, so I am really looking forward to learning more.  (In depth summaries and analyses of the ASH proceedings can also be found in the Beacon’s ASH coverage.)

In the meantime, now that Deana has no restrictions whatsoever, I enrolled us in a pasta making class at an adorable Italian bistro inPittsburgh’s Strip District for the evening of March 6.  We are going to have fun from here on out.

We continue to be so grateful for the many organizations we are now part of, whether in person or online.

Deana is enjoying her guided relaxation classes and support group meetings at Gilda’s Club, where she has also obtained some terrific books, including “The Yoga of Relationships.”  She says this book has helped her gain some wonderful perspective.

I am thankful for the new friends I have made through the Atlanta Area Multiple Myeloma Support Group and regret that my schedule is not allowing me to participate as actively as I’d like.

There’s also the great work being done by both the International Myeloma Foundation and the Multiple Myeloma Research Foundation.  Again, I wish that I were able to contribute more to the outstanding activities of both groups, whose efforts to date most certainly are a factor in Deana’s progress.

I am also so grateful for The Myeloma Beacon and the community it provides.  The thoughts of my fellow columnists, reader responses to columns, and the information about the medical side of multiple myeloma have been tremendously helpful.

As a child, I loved all of the alphabet books that attributed a word to each letter, so I couldn’t resist titling this article “R Is For Remission.”  If you or your loved one is not to this point yet, I hold good thoughts and send energy your way with the hope that you too will soon get the news you desire.

Some have taken a chronological approach to describing the events leading up to their diagnosis, through their treatment, and to where they are currently.  Others have written about their struggles with side effects, relapsing, and dealing with the disease emotionally.  Some have provided tips based on their own experiences, and others have told their story with humor and a positive outlook.

As a service to its readers, The Myeloma Beacon has compiled a list of the columnist articles Beacon readers found most interesting during 2011.  If you sometimes feel like you are battling this disease alone, please read these columns.  It helps to know others have had similar experiences.

Also, please join all of us here at The Beacon in expressing our sincere appreciation to these columnists for taking the time, and for being willing, to share their personal stories with the Beacon’s readers on a regular basis.

Arnie’s Rebounding World by Dr. Arnold Goodman

Dr. Arnold Goodman was diagnosed with multiple myeloma in 2006 at the age of 47.  He has been living with relapsed/refractory disease and has been treated with a number of different drug regimens.  Dr. Goodman writes a monthly column for The Myeloma Beacon.  Below are two of his articles that Beacon readers have found particularly interesting.

A Journey From Diagnosis To Relapse And Beyond – In his first column, Dr. Goodman described how six years ago he started getting out of breath more easily while exercising, which led him to order blood work that uncovered his cancer.  He also wrote about how he selected where to go for treatment.

My Stem Cell Transplant – In another column, Dr. Goodman described the stem cell transplant process for patients who may be considering one.  He also wrote about his personal experience with an outpatient transplant, and how he needed to be admitted to the hospital due to a fever but recovery was speedy once the transplanted cells started to grow.

Big Sis In Burgundy by Deborah Dietzler

Deborah Dietzler’s sister Deana was diagnosed with multiple myeloma in April 2011 at the age of 39.  Less than two months after Deana’s diagnosis, Deborah began writing a Beacon column from a caregiver’s perspective.  Her column is published every other week.

My Sister Has What?!?! – In Deborah’s first column, she described in detail the events leading up to Deana’s diagnosis.  She also wrote about how she, as the sister of a cancer patient, was affected in the first four weeks after the diagnosis.

Birds In Spring by Lou Ganim

Lou Ganim was diagnosed with multiple myeloma in 2006 and has undergone two autologous stem cell transplants since then.  He writes a monthly column for The Myeloma Beacon.

The Story Of My Diagnosis And Initial Treatment – Lou stepped back in this column to describe for newly diagnosed myeloma patients the early days of his life with myeloma, including his diagnosis, initial treatment, and complications.

Pat’s Cracked Cup by Pat Pendleton

Pat Pendleton was diagnosed with multiple myeloma in December 2003 and has been in remission for the past six years.  She writes a monthly Beacon column.

Grateful For Perspective – Pat took Thanksgiving as an opportunity to reflect on her feelings around the time of her diagnosis and on how her perspective has changed over the course of her disease. She expressed gratitude for the change in perspective.

Pat’s Place by Pat Killingsworth

Pat Killingsworth was diagnosed with multiple myeloma in April 2007 at the age of 51.  After relapsing in 2010, Pat underwent a stem cell transplant in mid-2011.  Unfortunately, the transplant did not put his cancer in remission.  Pat wrote a weekly column throughout most of 2011 and now writes monthly.

My Myeloma Therapy Is Working – But Not Without Significant Side Effects – In early December, Pat announced that his post-transplant therapy is working to lower his monoclonal protein level (M-spike).  He also shared the side effects of his treatment, including low blood cell counts, peripheral neuropathy, low blood oxygen levels, and more.

Anger Rises Among Some Multiple Myeloma Patients As They Await A Cure – In this column, Pat discussed people’s feelings toward the speed of advances in myeloma therapy.  While the approval of the novel agents several years ago was a significant step forward, many myeloma patients are still angry that only small, incremental steps are being made toward a cure.

Dealing With Peripheral Neuropathy – Pat described reasons why myeloma patients experience peripheral neuropathy (pain and tingling in the extremities caused by nerve damage), symptoms of neuropathy, and suggestions about how to deal with the condition.  Many myeloma patients shared additional tips in the comments section of the article.

Sean’s Burgundy Thread by Sean Murray

Sean was diagnosed with multiple myeloma in November 2008 at the age of 49 and with two young daughters.  He chose to pursue aggressive therapy and is currently in complete remission.  Sean writes a monthly Beacon column.

Positively Myeloma – In his column, Sean talked about his outlook on life since his myeloma diagnosis.  He shared how he manages to remain positive even though “myeloma sucks,” as he put it.  Sean’s family, faith, and humor are just a few of the things that help him live with cancer one day at a time.

Manhattan Tales by Stephen Kramer

Almost two years after being diagnosed with myeloma in January 2010, Stephen Kramer started writing a column for the Beacon in December 2011.

The Diagnosis – In Stephen’s column from last year, he wrote about the events leading up to his diagnosis.  He also briefly described that treatment put him in remission but forced him to retire due to the side effects interfering with his job.

Me vs. MM by Kevin Jones

Kevin Jones was diagnosed with multiple myeloma in January 2011 at the age of 52.  He began writing a monthly Beacon column in December 2011.

The Beginning – In his first column, Kevin wrote that his diagnosis came as a surprise, given that he had been relatively healthy his entire life.  He also described his treatment progress to date and how he is hopeful in his battle against cancer.

The Myeloma Beacon also recently published compilations of the top Myeloma Beacon news and resource articles from 2011.

In addition, the company said that it plans to submit a similar application to the European Medicines Agency (EMA) during the first half of this year.

The updated submission timeline means that pomalidomide could be approved for use in the United States and in Europe by the end of this year.

Celgene’s announcement was made in a company earnings report.

Pomalidomide, which belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lena­lidomide), is being developed by Celgene (NASDAQ: CELG) for the treatment of multiple myeloma and myelofibrosis.

Results from the latest clinical trials involving pomalidomide were presented at the American Society of Hematology meeting last month (see related Beacon news).  Physicians and industry analysts have responded positively to the drug’s performance, particularly among patients previously treated with both Revlimid and Velcade (bortezomib).

Under the FDA’s standard review process, the agency must decide whether to approve a drug within 10 months of the time the drug is submitted for review.  However, the FDA can grant priority review to drugs that offer significant advances in treatment, particularly for diseases in which there are inadequate treatment options. If the FDA grants pomalidomide priority review, the agency would need to complete its review of the drug within six months.

Thus, if the FDA approves pomalidomide based on the application Celgene submits this quarter, the drug could be available for use in the U.S. by the last quarter of 2012 or early 2013.

In Europe, the EMA must review drug applications within 210 days of submission.  If, however, a drug is granted an accelerated assessment due to therapeutic innovation or because it is of significant interest to the public health, the EMA must review the application within 150 days.

These timelines mean that, if the EMA approves pomalidomide based on the application Celgene submits during the first half of this year, the drug could be available for use in Europe by the end of 2012 or the first quarter of 2013.

An EMA approval of pomalidomide would allow the drug to be marketed in all 27 countries of the European Union and in Norway, Iceland, and Liechtenstein.

Along with carfilzomib – which works similarly to Velcade – pomalidomide is considered one of the most promising new myeloma treatments that could be approved by the FDA in the next few years.

For the full earnings report, see the Celgene website.

Tuesdays and Fridays, I would take a ten-minute subway ride from our home in lower Manhattan to Greenwich Village, spend an hour at the clinic getting my “infusion,” and then stop off at one of the many great food stores at the cavernous Chelsea Market, a block from the clinic.

I’d then hop back on the subway and get to work, usually by 11 a.m.  I was upbeat.  This seemed bearable.

An early hint that I might be involved with more than just the physical side effects that I had been warned about occurred a few weeks after beginning the treatments.

One Friday evening, I slipped into an open space on a very crowded subway car just as the doors were closing.  I found myself next to a passenger who was very visibly distressed at being pressed against other travelers.  The car was too crowded for me to move away from him.  I gave a glare back at him to warn him to stay away and pretended to wander into an anonymous reverie.

As I pushed by him to leave the subway car at the next station, the angry passenger gave me a quick shove.  I lost my balance and ended up with one of my legs fallen into the gap between the subway car and the platform, the other stretched straight out on the platform itself.

Several passengers waiting to get in the car immediately lent a hand and lifted me up – I never could have worked my jammed leg out from the gap without help.   I limped off and started to shake, not just from the pain and the danger.

I sensed that my judgment had been way off: not only should I not have squeezed into the crowded car, I never should have made direct eye contact in a crowded subway car with anyone who appears so odd.

I stopped limping a few days later, and my scraped leg quickly healed.  However, a couple of weeks later I had another hint that my judgment was amiss.

On yet another Friday evening after my chemotherapy, I grew frustrated with a close friend late at work when I was eager to leave.  He kept changing his mind on some issue we were discussing, and I ended up yelling at him to make up his mind and slammed down the phone.

When I apologized to him on Monday, he told me to forget about it – he told me his wife had gone far more berserk the previous year when she had been prescribed a light dose of steroids, and he knew that my doses were much heavier.

But this event really shook me up.  My job as the legal counselor to the New York City Buildings Commissioner was high pressure – New York City real estate developers and their contractors and labor unions were constantly calling, as was the press office, community groups, elected officials, and the mayor’s office.

I couldn’t afford to lose my cool.  In addition, the physical side effects were getting significant.  I needed a nap almost every day.  A stem cell transplant appeared to be on the horizon in the late fall anyway.

For the first time, I began to seriously think about retirement  — something I had given very little thought to.

A year and a half and a few “exciting” incidents later, I know I made the right decision to retire.  All these incidents were too odd and numerous to be by happenstance. New York seems not to be a laid back place.

More details are provided in this article to answer multiple myeloma patients’ questions about the FDA decision.

What exactly did the FDA approve?

The FDA approved a supplemental new drug application for Velcade (bortezomib), which is an application to make changes to an already approved product.  Specifically, the FDA approved updated prescribing information that now says Velcade can be administered by intravenous (in the vein) injection or subcutaneous (under the skin) injection.

A drug’s prescribing information is an official document that describes the FDA’s approved uses of the drug, dosage and administration information, efficacy and safety data, and other pertinent information about the drug.

Velcade’s updated prescribing information also includes instructions on how to prepare and inject Velcade subcutaneously, a recommendation that subcutaneous administration should be considered for patients with pre-existing or at high-risk of peripheral neuropathy (pain and tingling in the extremities), as well as safety and efficacy data comparing intravenous and subcutaneous administration of Velcade.

What impact will the FDA decision have on myeloma patients in the U.S.?

Prior to the FDA decision, many treatment centers in the U.S. did not offer subcutaneous Velcade.  With the recent FDA approval, Dr. Ravi Vij, a myeloma specialist from Washington University in St. Louis, said, “I anticipate that the subcutaneous route will become the preferred route for administration of [Velcade].”

Some myeloma patients were receiving Velcade by subcutaneous injection prior to the FDA’s recent decision, so how will the FDA approval change anything?

Once a drug is approved by the FDA, physicians may prescribe the drug in ways that differ from the FDA approval, such as for other diseases or via a different route of administration.  However, FDA approval is an important sign to the medical profession of what is strongly supported by available clinical data.  Therefore, it has a definite impact on medical practice.

FDA approval also influences reimbursement decisions by health insurers.  The approval of subcutaneous Velcade should eliminate resistance by insurance companies to the reimbursement of Velcade when it is administered subcutaneously.

What impact will the FDA decision have on myeloma patients outside the U.S.?

Janssen, the Johnson & Johnson subsidiary that markets Velcade outside of the U.S., submitted an application in March 2011 to the European Medicines Agency for the approval of subcutaneous Velcade.  Although the European agency has not yet issued a decision, myeloma specialists from several European countries have indicated that subcutaneous Velcade is already being used in their countries (see related Beacon news).

A spokesperson from Janssen said that the company also has plans to seek approval in additional countries.

Dr. Vij indicated that he anticipates that the subcutaneous route will also become the preferred route for patients outside of the U.S.

What are the benefits of subcutaneous Velcade compared to intravenous Velcade?

According to Dr. Vij, “The major advantage is lower rates of neuropathy.”  Results from a Phase 3 trial showed that subcutaneous injection of Velcade significantly reduced the rate of severe peripheral neuropathy (6 percent of patients) compared to intravenous injection (16 percent).

“Subcutaneous administration is also more convenient for patients as it is quicker, so they do not have to spend as much time in the doctors’ offices,” added Dr. Vij.

When will subcutaneous Velcade be available?

Subcutaneous Velcade is available immediately.  It is the same formulation as intravenous Velcade; no new form of Velcade needs to be ordered by health care professionals.  Velcade comes packaged as a single-use vial of powder.  The same dose is used regardless of the route of administration.  However, the powder should be dissolved in a different amount of saline solution based on the route of administration.  The updated prescribing information provides instructions for how much solution to use for each type of administration.

Does the approval mean that Velcade will have to be given subcutaneously?

No.  Velcade can be given intravenously or subcutaneously.  However, the prescribing information specifically states that Velcade should not be administered by any other route.

Will all treatment centers in the U.S. offer subcutaneous Velcade?

Dr. Vij believes that all treatment centers will offer subcutaneous Velcade.

Now that subcutaneous Velcade is FDA approved, is subcutaneous administration recommended or preferred compared to intravenous administration?

“I think that the subcutaneous route will be preferred apart from some patients who have a reaction, infection, or bruising after subcutaneous administration, in which case the intravenous route may still be employed,” said Dr. Vij.

About 6 percent of patients who receive subcutaneous Velcade experience a reaction at the injection site.

For more information, see the Velcade prescribing information (pdf).

Taming and transforming the multiple myeloma beast takes more than a dragon, but inspiration helps. Sometimes the dreams that occur during sleep can lead to new meaning and ways to see how the mind and body work together.

The science of medicine does not pay much attention to mythology, astrology, or dreams. Many consider dreams as nothing more than chemical phenomena of the brain.

I was reminded of “chemo dreams” when I read Kevin Jones’ recent Beacon column, Me vs. MM: The Psychological Barrier.

Daily life is a waking dream that we call reality, but the activity of our sleeping mind produces an alternate reality that often feels just as lively. The chemo dream seems to be a combination of the two – a parallel universe of sorts.

I experienced some drug-induced dream states during my treatment days, especially during a hospitalization. These seem to have been triggered by the powerlessness that comes with being a patient.

One such dream took place in the very room in which I was being treated. Staff streamed in and out checking and measuring me, and the machines kept beeping. This sounds fairly routine, but in the dream, I believed that I was locked in the room and the victim of a sinister experiment.

The condition of serious illness does leave one in a state of suspended understanding. We really do not know what is happening to us. The origination of the term “patient” implies an individual who must wait, and wait – and wait even more. The only option is patience.

The dreams tapered off, but they resumed long after I discontinued all medications. A rich dream life emerged to include lions, tigers, and bears. All sorts of non-human life forms have entered my dreams –  fish, rats, birds, spiders, beasts. I consider these my survival dreams.

Engaging with the natural world in dreams has connected me more solidly to the life force. Shamanistic cultures have always known this.

Another dream featured frightening, but humorous-looking, Dr. Seuss-style mythical creatures moving toward me as I was backed up against a wall. It was a moment of active dreaming where I intentionally called out to them, “Go away!” Surprisingly, the beasts turned around and left me alone.

Dreams of creatures have stopped, but dreaming has continued.

People commonly dream of being in unfamiliar places, wearing the wrong clothes, etc.

Just last week, one of those dreams appeared to me. I was walking down the street when I realized that my hair was falling out in clumps (a frightful moment for anyone who has ever lost their hair during chemo). I wanted to head back to the place where I was staying, but I did not know which way to go. I was going to call someone, but I did not have my cell phone. I was also wearing no shoes.

We’ve all been in similar dream situations. Waking up to our “real life” is a relief. Finding meaning takes more time and effort for those who choose to go there. Messengers within and around us have wisdom to share. I regard my dreams as an extension of my waking life.

If the dragon year can inspire transformation and rising to the challenges of the day, I’m listening. Drink some tea, and open a fortune cookie. Cheers!