CC-4047, Pom/dex, Improves Or Stabilizes Disease for 76 Percent of Relapsed Multiple Myeloma Patien

a new combination of medications designed to maximize immune functions improved or stabilized multiple myeloma

Article Type: Therapies
Publication Date: Mon 08-Dec-2008 11:05 ET
Source: Newswise
Source Type: online pr

Mayo Clinic researchers have found that a new combination of medications designed to maximize immune functions improved or stabilized multiple myeloma for 76 percent of patients who had relapsed after previous treatment.

Interim results of an ongoing clinical trial evaluating pomalidomide, a new immunomodulatory agent, combined with dexamethasone (pom/dex), were presented today at the 50th Annual Meeting of the American Society of Hematology in San Francisco. Pomalidomide, also referred to as CC-4047, is the latest in the class of immunomodulatory agents that also includes thalidomide and lenalidomide.

Multiple myeloma (http://www.mayoclinic.org/multiple-myeloma/) is a cancer of the plasma cells, a type of white blood cells in the bone marrow, that affects approximately 3 in 100,000 people each year. There is no cure. While the condition can be managed, often with good results, the disease can lead to erosion of the bones, causing bone pain and fractures.

Immunomodulatory drugs work by interfering with cancer cell growth and by stimulating the immune system to attack the cancer cells. The Food and Drug Administration (FDA) has approved the use of thalidomide and lenalidomide to be given with dexamethasone for previously treated cases of multiple myeloma.

The study opened in November 2007 and has accrued 60 patients. To date, 58 percent of patients have responded to therapy with at least a 50 percent drop in the detectable tumor burden as measured by blood protein levels, a marker for myeloma. This included one patient who achieved a complete remission -- no signs of the cancer -- and 14 patients (23 percent) who achieved at least a 90 percent drop in blood proteins. Eleven other patients (18 percent) remained stable.

“These are high remission rates, and they happened quickly,” says Martha Lacy, M.D. (http://www.mayoclinic.org...), Mayo Clinic hematologist and lead researcher on the study. Also encouraging, says Dr. Lacy, is that treatment did not cause significant side effects in most patients. Side effects included anemia and declines in blood counts, most often mild in both.

In the study, patients took pomalidomide (2 milligrams [mg]) orally daily for a 28-day cycle. Dexamethasone (40 mg) was taken orally on days 1, 8, 15 and 22 of each cycle. Patients also took 325 mg of aspirin daily to prevent blood clots, a concern associated with immunomodulatory agents. Blood clots can occur with use of any IMiD, but the risk increases as the dose of dexamethasone increases.

The dosage of dexamethasone in the current trial is one-third of the dose that was used in the registration trial that led to FDA approval for lenalidomide in previously treated myeloma patients. “We’re getting good results with less toxicity compared to what we’ve seen in the past,” says Dr. Lacy. “And, so far, no patients have had blood clots.”

Another key finding was that pom/dex was helpful for 29 percent of patients who previously did not respond to treatment with lenalidomide.

“We are excited about the potential of this drug combination to significantly help patients with myeloma,” says Dr. Lacy. “Based on these encouraging results, we are expanding the study to include other patient populations that may benefit from this therapy.”

This sponsored research study was funded by Celgene. Other Mayo researchers involved in this study include: Suzanne Hayman, M.D.; Morie Gertz, M.D.; Angela Dispenzieri, M.D.; Steven Zeldenrust, M.D., Ph.D.; Shaji Kumar, M.D.; Philip Greipp, M.D.; John Lust, M.D., Ph.D.; Stephen Russell, M.D., Ph.D.; Francis Buadi, M.D.; Robert Kyle, M.D.; Rafael Fonseca, M.D.; P. Leif Bergsagel, M.D.; Vivek Roy, M.D.; Joseph Mikhael, M.D.; Keith Stewart, M.B.Ch.B.; Jacob Allred; Kristina Laumann; Melanie Thompson; Sumithra Mandrekar, Ph.D.; and S. Vincent Rajkumar, M.D.

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This is the study that I am on

This stuff works. I am one of the many people in the group of 60 whose M-spike dropped dramatically on pomalidomide/dexamethasone, from 2.7 g/dL at the start to 1.0 g/dL, where it seems to be stable.

Don

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I am copying and pasting the exact message I have written to the ACOR and mma lists as I think it will say it best. If you have already read, I apologize.

David, I don't know how to introduce a new subject so have attached it here.

I have had myeloma since July of 2000 and find myself at a new place where I would like to hear your ideas, experience, etc.

Briefly, I have always consulted with Dr. Durie and had treatment with a local oncologist. I have Iga./Lambda mm. I had dex as a treatment alone and responded well. Although, I have had not had an aggressive mm, I have had a rather steady mm. Next I went to thalidomide/ dex for probably 2 years and quit abruptly on my own because of worsening peripheral neuropathy. I discussed several possiblilties for treatment with Dr. D and went on cytoxan/dex. I did this for over 2 years and went into a plateau. This takes me up to about a year ago. After all these years of dex (at least I blame dex) the muscles in my legs are very weak and I also have severe osteoarthritis made worse by dex. I had back surgery in Jan 2007 which helped only slightly with a numbness and problem in my leg. During my use of cytoxan, my wbc, hgb, and platelets dropped steadily and stayed low. I went from seeing the doctor monthly to weekly often receiving neuopogen or aranesp shots or both. Recently, they dropped lower and a surgeon refused to do a planned knee replacement which I now think was a good idea. The last time my blood was taken my wbc was 3.5, my hgb was 7.5, my rbc was 2.65 and my platelets were 73 (actually up from 45). My oncologist did a bmb and bma in the office that day and I have received the results which say 70% myeloma in the bone marrow and that I have developed myelodydysplasia but it is in the early stages and not too bad. My oncologist says I must be treated immediately and I am scheduled for Velcade this Monday. My oncologist knows and encourages my consulting with Dr. Durie. My Iga is presently 908. (not particularly high compared to past numbers) Lambda free light chain is 205.00mg/dL which is higher than it has been but doesn't have a lot of meaning to me. My 24 urine test once showed lamba light chains in the 6,000's and that had meaning to me. Dr. Durie is out of town but I have an appointment with him next Wednesday. I did some research on mds and it is now being treated with revlimid. I am curious if Dr. Durie will suggest revlimid as it seems logical. I have never taken revlimid because of the cost. Are any of you getting revlimid through the Medicare drug prescription program? I have Humana. Any other ways that any one is getting revlimid at a reasonable cost. I also suggested to my local oncologist that perhaps I should wait on the Velcade until I see Dr. Durie but he wants me started immediately and I am reasoning that it can't hurt anything. I welcome all ideas and thoughts. I would like to hear from anyone who has had low blood counts such as mine and recovered.

Thank you, glenda

Submitted by Glenda Cook (not verified) on Fri, 12/12/2008 - 16:08.

Need help

Hi Glenda,

I think highly of Dr. Durie and agree with the process of a local onc coupled with discussions with Dr. Durie.

I will add links to articles on the site on velcade and revlimid- I have no personal experience with either.

Managing pn as side effect-

http://beating-myeloma.or...

Rev/vel/dex combo?

http://beating-myeloma.or...

Don refers to the trial that he is on- pom/dex.

"This stuff works. I am one of the many people in the group of 60 whose M-spike dropped dramatically on pomalidomide/dexamethasone, from 2.7 g/dL at the start to 1.0 g/dL, where it seems to be stable." Don

Alex Maas talks about the substitue for dexamethasone-

I hope these articles offer some ideas, Glenda. Hang in there.

David

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reveals problems with my spine in lower back area that is causing it plus i yr on Thalidomide seems to have caused some of the numbness. I'm off Thal. now for 3 months.but there is no reversal. Some days not quite as bad though.

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