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Exciting Multiple Myeloma Data at ASH

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This is from a reader.

Subject: Exciting Multiple Myeloma Data at ASH

Message: Hi Beth,
Here are some data highlights from The 50th Annual American Society
of Hematology (ASH) Meeting this week:

  • Updated results from the ECOG study evaluating Revlimid plus low-dose dexamethasone in newly diagnosed patients was presented by Dr. Rajkumar in a joint symposium of the American Society of Clinical Oncology and ASH.  The results are the highest 3 year overall survival rates ever reported in this patient group.
  • Data presented by Dr. San Miguel showed that relapsed/refractory patients who received continuous treatment with Revlimid and dexamethasone after achieving their best response lived longer and had increased time to disease progression compared to those who discontinued treatment after ten months or less.
  • Dr. Lacy presented data which showed that pomalidomide with dexamethasone has promising activity for patients with relapsed/refractory MM.   Results from this ongoing trial showed high remission rates.

Best,
Allison

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IMF Says 90% overall response with new Relvlimd® combination (BiRD)

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This is a press release  from the  International Myeloma Foundation.

I was on Revlimid with high dose dex for some time back in 2005, I think. I remember being miserable on the high doses of steroids and that my MM progressed after I cut back.  We figured the Revlimid didn’t work for me. But that doesn’t mean that it might not work if I added Biaxin.  It’s one more thing I can try when I have to start treatment again. The thought of having to take steroids again kind of causes a feeling of anxiety.

­–BiRD Study (Biaxin®-Revlimid-Dexamethasone) Provides Evidence of Deep Complete Response Rates In Newly Diagnosed Multiple Myeloma–

North Hollywood, CA, January 4, 2008 – The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians—today said updated data from the Phase II BiRD study provide a new option for newly diagnosed patients with multiple myeloma whether or not they proceed to stem cell transplant. The findings show a superb overall response rate of 90.3%. 38.9% of the patients achieved a complete response (using EBMT criteria) and 73.6% achieved a 90% or greater decrease in m-protein levels. Using the new International Myeloma Working Group Criteria—recently developed to better define the magnitude of a complete response by a panel of experts led by Brian G.M. Durie, M.D., chairman and co-founder of the IMF—30.6% of the patients achieved this new stringent complete response* (sCR). The findings have been published in the online version of the journal BLOOD.

The BiRD regimen is made up of REVLIMID® (lenalidomide) plus a low dose of the steroid dexamethasone, and adds Biaxin® (clarithromycin). The BiRD treatment did not impede stem cell transplantation, and demonstrated two-year event-free survival rate of 85.2% for patients who underwent stem cell transplant and 75.2% for those who continued on therapy without transplant. Median event-free survival time was not reached.

In addition to the response criteria, the findings from the BiRD study, like a previous study of REVLIMID with low-dose dexamethasone, show response deepening over time: the average time to partial response was just over six weeks, but average time to complete response was 22 weeks, and stringent complete response was reached at 38 weeks.
"This is an exciting time for the treatment of myeloma," said Susie Novis, president and co-founder of the IMF. "We now have multiple studies showing improved response and survival with various regimens including REVLIMID/dexamethasone in previously treated and newly diagnosed patients, DOXIL®/VELCADE® for previously-treated patients who want a steroid-free regimen, and thalidomide/melphalan/prednisone in older patients not eligible for transplant."

Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It affects an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing numbers and in increasingly younger people.

The data were published in an article by lead author Ruben Niesvizky of the Multiple Myeloma Service, Division of Hematology and Medical Oncology, Weill-Cornell Medical College, New York Presbyterian Hospital-Cornell Medical Center.

* sCR requires complete absence of M-protein by immunofixation, normal free light chain ratio and a negative marrow biopsy by immunohistochemistry.

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 120 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF was rated as the number one resource for patients in an independent survey by the Target Research Group. The IMF can be reached at (800) 452-CURE, or out of the United States at (818) 487-7455. More information is available at www.myeloma.org.

Media Contact: Stephen Gendel or Jennifer Anderson (212) 918-4650

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Sleep is good

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When I got home from having Doxil and Velcade yesterday, I could hardly stay awake. I have benedryl in my IV to try to keep me from getting those hives from the Velcade. They’re not completely eliminated, but much less severe with the benedryl and dexamethasone. However, it makes me very sleepy! It’s amazing that when I have IV benedryl, it has this effect on me. When I take a pill, I hardly feel it at all. I can feel the benedryl move up the veins in my arm when it’s pushed. It burns. Then I feel like I’m drunk. When I get home, all I want to do is sleep. So, that’s what I do. It’s not as though I have a choice.

Today I got up early. I bought some sod for the back yard, and someone came to lay it down, but his helper left at lunch time. After lunch, I looked out the window and saw him and his mamacita working out there, so I decided to go help them. Boy, is that back breaking work! I had done another part of the yard a few months ago, which is why I decided to hire someone to do it this time. Thank goodness it started to rain. We all got to quit then.

Anyway, after working hard today and having chemo yesterday, I’m beat. It will be an early night for me.

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Effectiveness of bortezomib (Velcade)

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Until I just did some reading, I hadn’t realized that Velcade doesn’t work for about 2/3 of us. I have been told by my doctor, however, that it does seem to work especially well for IgA MM patients (I’m one of those).

“Bortezomib seems to work in about one-third of patients who use it, but we have not been able to predict which ones,” says the study’s lead author, Leif Bergsagel, M.D., a hematologist at Mayo Clinic Arizona. “We now have identified a group that will likely respond because these nine mutations seem to be present in at least 25 percent of newly diagnosed patients.” From http://www.mayoclinic.org/news2006-rst/3817.html

The combination of Velcade + Doxil does have better results in people who respond to it. Based on a study conducted at UNC and other places, Dr. Orlwoski reports, “the combination group’s median time to progression – the time interval between the response to treatment and the time the disease starts to show evidence of growing or recurring – was 9.3 months, while those on Velcade alone progressed after 6.5 months.”
From: http://www.unchealthcare.org/site/newsroom/news/2006/Dec/myeloma. One question I have to remember to ask about this is, is this TTP after the 8 21-day cycles of treatment?

I still haven’t decided whether or not I’m going to add IV dexamethasone to the Velcade/Doxil regimen. I have until Tuesday to decide.

I hate to admit this, but I’m envious of the people who have remissions from their first line of treatment. Any treatment, to be honest. I’m secretly hoping for such good results from Velcade that I’ll decide to wait for relapse to have an SCT. What? It could happen!

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Another year

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I can’t believe it. Another year is almost over.

I haven’t written much in the last several days. A lot’s been going on, but I haven’t had time to write. And, my typing finger is sore from work. :)

I had an appointment with Don Gabriel, a transplant doc at UNC. He’s a very nice guy, and I liked him instantly. I’ve been researching a potential problem he brought up, but have discovered that it’s not a problem at all. Some doctors believe that, to have a successful stem cell transplant, the cells must be harvested when the % of plasma cells in the bone marrow is below a certain number (like 20%). Mine were at 30% at the time of my harvest. I was very worried that I might have to go through the harvest process again, but I put in an SOS to the IMF and was assured that I’ll be ok to go ahead without a second stem cell collection by members of the scientific advisory board. Now my questions are: Do I have to have more treatment before the SCT? Can I use just melphalan alone, since cytoxan didn’t have any effect on my myeloma?

I’m scheduled to begin Velcade + Doxil and possibly dexamethasone on January 9th, 2007. Of course, I’d be happy to find out that I didn’t need additional treatment before the high dose chemo, but I’m guessing it’s not likely. It’s all getting closer, and I’m nervous and afraid.

In the mean time, I’m going to try to forget that I have cancer. I’m just going to enjoy this treatment-free time.

Oh! For those of you who wonder about this… when you stop dexamethasone, you do lose weight (if you gained it from the steroids). Without trying, in my case, which is cool. I still have the moon face. I wonder how long it takes for that to go away? Anyway, I lost just under 25 lbs so far. I’m guessing the chemo and the SCT will melt away the pounds as well, but I don’t recommend it!

Amneris Solano, thanks for the very nice article you wrote in the Fayetteville Observer. Thanks, Matt Moriarty, for the article you wrote for the Pilot. I hope we’re successful in raising the money we need for the IMF.

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Anti-emetics

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I meant to post this earlier. When I had the Cytoxan back in October, I was worried about the possibility of nausea and vomiting, so I asked for lots of meds to help prevent it. It was 100% effective. The worst side effect I felt was reflux that night.

Ondansetron (Zofran) – 8 mg tabs. I think I had 3 a day.
Dexamethasone – 2 mg tabs
Prochlorperazine (Compazine)- 5 mg tabs
Lorazepam (Ativan)- inj 0.5 ml

When I went home, I had Ativan and Compazine to take every 4-6 hours. That helped a lot, because I felt somewhat queasy for a few days after.

If you’re going to have chemo, and are worried about the nausea & vomiting that can be a side effect of many of these drugs, speak up ahead of time and let your doctor know that you want lots of drugs to try to prevent it. Why suffer? Oddly enough, some docs/nurses wait until you report feeling nauseated before they give anything. I think premedicating and staying on the anti-emetics for as long as needed is the way to go.

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Next appointment

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I have my next appointment to check up on things on Tuesday at UNC. I’m going back to see Dr. Orlowski. I originally switched to Wake Forest so I could get Revlimid before it was approved by the FDA. There are a variety of reasons why I decided to go back to UNC.

Anyway, I haven’t had any treatment since the chemo in October, and this is the longest I’ve gone without since 2003. It feels wonderful not to be taking drugs, and I’m trying not to think about what the myeloma might be doing. I’m just trying to enjoy the time off, especially from steroids (dexamethasone).

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Rev/dex trial results

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ATLANTA, June 5, 2006 /PRNewswire-FirstCall via COMTEX/ — Celgene Corporation (CELG : news, chart, profile ) announced updated clinical data from two multi-centered, randomized, double-blind, placebo-controlled Phase III pivotal studies evaluating lenalidomide plus dexamethasone in previously treated multiple myeloma patients were presented at the 42nd American Society of Clinical Oncology (ASCO) Meeting in Atlanta, Georgia on Monday, June 5, 2006.

The updated clinical data from the pivotal North American Phase III trial

(MM-009) reported overall survival (p<0.0001) in addition to median time to disease progression (p<0.0001) in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo. The updated clinical data from the pivotal International Phase III trial

(MM-010) reported overall survival (p=0.03). As of June 2006, median overall survival in the International trial in patients treated with lenalidomide plus dexamethasone has not been reached as compared to 20.6 months with dexamethasone plus placebo.

Dr. Weber presented updated results from the North American Phase III special protocol assessment trial (MM-009) that reported:

* The median overall survival (OS) with lenalidomide plus dexamethasone

was 29.6 months, compared with 20.2 months for dexamethasone plus

placebo (p<0.0001)

* The median time-to-disease progression (TTP) with lenalidomide plus

dexamethasone was 11.1 months, compared with 4.7 months for

dexamethasone plus placebo (p<0.0001)

* Best response rate with lenalidomide plus dexamethasone was 59.4

percent, compared with 21.1 percent for dexamethasone plus placebo

(p<0.001)

* Complete response (CR) rate (based on EBMT criteria) with lenalidomide

plus dexamethasone was 12.9 percent, compared with 0.6 percent for

dexamethasone plus placebo (p<0.001)

* The most common side effects observed in this trial with the

combination of lenalidomide and dexamethasone were constipation,

diarrhea and neutropenia

Both trials were randomized, double-blind, placebo-controlled, phase III studies using lenalidomide plus dexamethasone versus dexamethasone plus placebo in previously treated multiple myeloma patients.

Patients in both lenalidomide trials had been heavily treated prior to enrollment, many having failed three or more rounds of therapy with other agents. In addition, more than 50 percent of patients in the study had undergone stem cell transplantation.

These trials were designed to investigate the effectiveness and safety of cyclic dosing of lenalidomide at 25mg combined with high-dose dexamethasone

(HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. These trials enrolled 705 patients and are being conducted in 97 sites internationally. Lenalidomide and HDD are given in 28-day

cycles: lenalidomide 25 mg once daily on days 1-21 every 28 days, and HDD 40 mg on days 1-4, 9-12 and 17-20 every 28 days. After four cycles the HDD schedule is reduced to 40 mg on days 1-4 every 28 days). The primary endpoint of the study is time-to- disease progression calculated as the time from randomization to the first documentation of progressive disease based on EBMT myeloma response criteria.

In the North American trial, patients treated with lenalidomide and dexamethasone had an increase in side effects as compared to patients treated with dexamethasone plus placebo. Grade 3/4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis and pulmonary embolism occurred in 14.1 percent of patients treated with lenalidomide plus dexamethasone, compared to 3.4 percent of patients treated with dexamethasone plus placebo.

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