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February 26, 2004 Myeloma Minute
What's News

Question of the Week: Thal/Dex Tx

Q: My doctor just started me on 200 mg per day of thalidomide along with dexamethasone and has told me he intends to increase the dose to 400 mg over the next two weeks.  Is this the standard dosage for a patient with newly diagnosed myeloma?

A: No large trial data sets are available to define for us what “standard” therapy with thalidomide and dexamethasone should be in newly diagnosed myeloma. Many studies are ongoing. A large research study at the Mayo Clinic under Dr. Vincent Rajkumar established that thalidomide and dexamethasone produces a response rate comparable to VAD with less toxicity, and is an appropriate therapy option prior to high-dose therapy with stem cell autotransplant.

The issues of thalidomide and dexamethasone dosages and scheduling are still unresolved.  Currently, the consensus among myeloma specialists is that 200 mg of thalidomide per day is the maximum dosage generally recommended in combination with dexamethasone. At over 200 mg per day, there are risks of added toxicities. In particular, patients may experience a type of exfoliating skin rash that can be severe, even life-threatening. When dexamethasone is given in combination with thalidomide at dosages > 200 mg per day, the risk of developing a blood clot (deep vein thrombosis [DVT]) is approximately 10%.  Using combinations including thalidomide, dexamethasone, and adriamycin or DOXIL (a long-acting form of adriamycin), the risk of DVT increases to 20-30%. This is especially true for a combination “DT-PACE,” developed at Little Rock , Arkansas . With this combination, Lovenox, a blood thinner, is recommended to prevent blood clots.  Coumadin, an oral blood thinner, can also be considered in patients taking thalidomide plus dexamethasone who are felt to be at increased risk for blood clotting problems.  This can be discussed with your doctor. It should be noted that with low doses of thalidomide (50-100mg/day), alone or combined with dexamethasone, clotting problems are less frequent. 

One approach to dosing with thalidomide is to start low (e.g. with 50 mg or 100 mg/day) and work up the dosage gradually. By working in this manner, possible adverse side effects can be encountered early or avoided altogether, since the occurrence and severity of side effects are related to the dosage. Monthly assessments of the level of monoclonal protein in the blood and/or urine will guide the oncologist in deciding whether the current dosage is sufficient or should be increased in 50-mg increments. In most patients, blood and/or urine tests will assess whether or not the patient is responding in a month or two.

Another approach is to start at 200 mg per day of thalidomide and work down to a lower dosage if the disease, as measured by the level of monoclonal protein, stabilizes at a low level.  The hematologist/oncologist will determine which approach is best for you, depending upon your particular situation. For example, if your disease is less aggressive and/or at an earlier stage, the doctor may decide it is appropriate to start with a lower dosage of thalidomide and work up gradually. The goal is to find the minimum dosage of the drug with the maximum effect. If, however, your disease is more advanced and/or more aggressive, the doctor might decide it is appropriate to start at 200 mg per day combined with dexamethasone. 

Just as thalidomide doses can be reduced, dexamethasone dosages may be reduced from the standard 40 mg per day, four days on, four days off regimen. For example, there can be a 10-day rest between pulses. The four-day pulses can also be reduced to one day a week dosing, and the 40 mg dose may be reduced to 20 mg, or even 16 or 12 mg once a week, again depending upon response and/or tolerance. Results from Cedars Sinai Cancer Center presented at the Salamanca Myeloma Workshop indicate that the reduction of dexamethasone to the one day a week schedule after the first month is much better tolerated and provides equivalent response and clinical benefit.

There are many more nuances to the dosing and scheduling of thalidomide and dexamethasone.  It is very important to discuss all questions and concerns directly with your doctor. We will address some of these concerns in subsequent Questions of the Week. For information on peripheral neuropathy caused by thalidomide, see the Question of the Week for May 9, 2003,

What's New in Research

What's New in Clinical Trials:
(Drugs listed In alphabetical order.)

If you would like to browse trials currently open for enrollment, visit the Clinical Trials page of the IMF web site. Among the links, you will find CenterWatch and EmergingMed. The IMF has entered into partnerships with them to assist you in matching trials to your particular patient profile (i.e., stage of disease, previous treatment, how well you are able to carry out the activities of daily living, etc.) and by doing so, increase your chances of being eligible. You can also learn more about clinical trials by reviewing materials from the National Cancer Institute.

Advocacy Update:

Quality of Life Update:

Upcoming Seminars and Conferences:

Minneapolis, Minnesota
March 12-13, 2004

San Diego
San Diego, CA
August 20-21, 2004

Vienna, Austria
April 17-18, 2004

Barcelona, Spain
September 18, 2004

Istanbul, Turkey
July 4, 2004

Paris, France
September 24, 2004

Support Group
Leaders Retreat

July 9 - 11, 2004

Durham, North Carolina
Torino, Italy
October 1, 2004

San Jose
July 16-17, 2004

San Jose, California
Teaneck, NJ
October 8-9, 2004

Upcoming Fundraisers:

FUNdraising Made Easy
You know you want to do something, but deciding on what to do can be confusing. The IMF can help. Last year, our members really rallied 'round the cause and raised a lot of money for myeloma research and programs.

We are already getting calls from new members who want to join in the effort and hold an event this year. Suzanne Battaglia is waiting for your call. She is here to help you plan and execute your event, so please write, call or email (SBattaglia@myeloma.org) so that you can get on our Calendar of Events!

See what you can do in your community to help further the goal of finding the cure!

Diane Jette and
the Paris Marathon
April 4, 2004
Paris, France

Golfing for a Cure
April 17, 2004
Louisa, VA

Spring Fling
May 16, 2004
Glendale, AZ

Kathy McCormick
Memorial Golf Tournament

July 26, 2004
Hampstead, MD

5th Annual JC
Golf Tournament for the IMF

May 22, 2004
Sauk Rapids, MN
14th Annual
Ribbon of Hope Gala

November 6, 2004
Los Angeles, CA

Exciting Opportunities

Items of Interest:

Be Part of the Cure!

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