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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 03/15/2006    Updated: 09/16/2008
Related Pages
Search for Clinical Trials 1
NCI's PDQ® Cancer Clinical Trials Registry.

Multiple Myeloma/Other Plasma Cell Neoplasms 2
NCI's gateway for information about multiple myeloma and other plasma cell neoplasms.
Thalidomide Effective in Multiple Myeloma

Reprinted from the NCI Cancer Bulletin, vol. 3/no. 11, March 14, 2006 (see the current issue 3).

Current treatment for multiple myeloma entails a long and intricate chemotherapy regimen that includes one or two transplants with a patient's own stem cells accompanied by the drug melphalan. The anti-angiogenesis agent thalidomide has proven to be an effective component of therapy, but questions remain about where in the course of treatment it can best be used. In the March 9, 2006, issue of the New England Journal of Medicine (see the journal abstract), researchers report superior event-free and complete response rates when the drug was used before and during primary therapy and also thereafter for maintenance. Yet the controls who took no thalidomide lived just as long. [See note, below.]

After 4.5 years, Dr. Bart Barlogie and colleagues from the University of Arkansas found that 56 percent of patients taking thalidomide had no adverse events - disease progression, relapse, or death from any cause - compared with 44 percent of controls following the same treatment regimen without the drug; and an even greater difference was seen in complete responses, 62 to 43 percent. But each group contributed comparably to the 190 patients who died during this time, "owing in part to significantly shorter survival after relapse in the thalidomide group," wrote the authors, 1.1 compared with 2.7 years. Further compromising the advantage for thalidomide were more serious adverse events, such as deep-vein thrombosis and severe peripheral neuropathy.

In an editorial, Drs. Michele Cavo and Michele Baccarani, of the University of Bologna in Italy, suggest one interpretation of the data was to reserve treatments such as thalidomide "for the sequential treatment of relapses as a means of controlling the growth or regrowth of tumor."

[Note: Longer-term follow-up data from this trial were subsequently published online May 20, 2008, in the journal Blood, showing that there was a survival advantage for those in the thalidomide group after all, but only among those with a high-risk type of myeloma; see the journal abstract 4.]



Glossary Terms

angiogenesis inhibitor (AN-jee-oh-JEN-eh-sis in-HIH-bih-ter)
A substance that may prevent the formation of blood vessels. In anticancer therapy, an angiogenesis inhibitor may prevent the growth of new blood vessels that tumors need to grow.
complete response (kum-PLEET reh-SPONTS)
The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.
melphalan
A drug that is used to treat multiple myeloma and ovarian epithelial cancer and is being studied in the treatment of other types of cancer. It belongs to the family of drugs called alkylating agents. Also called Alkeran.
stem cell transplantation (stem sel tranz-plan-TAY-shun)
A method of replacing immature blood-forming cells that were destroyed by cancer treatment. The stem cells are given to the person after treatment to help the bone marrow recover and continue producing healthy blood cells.


Table of Links

1http://www.cancer.gov/clinicaltrials/search
2http://www.cancer.gov/cancertopics/types/myeloma
3http://www.cancer.gov/ncicancerbulletin
4http://www.ncbi.nlm.nih.gov/pubmed/18492953