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A Phase II Clinical Trial of Bortezomib, Pegylated Liposomal Doxorubicin (DOXIL®), and Dexamethasone Followed by Thalidomide and Dexamethasone with or without Bortezomib in Patients with High-Risk or Resistant Multiple Myeloma
[Protocol 06-067]
- Full Title :
- PHASE II CLINICAL TRIAL OF BORTEZOMIB + PEGYLATED LIPOSOMAL DOXORUBICIN+DEXAMETHASONE FOLLOWED BY THALIDOMIDE + DEXAMETHASONE OR BORTEZOMIB + THALIDOMIDE+DEXAMETHASONE FOR PATIENTS WITH SYMPTOMATIC UNTREATED HIGH-RISK OR PRIMARY RESISTANT MULTIPLE MYELOMA
- Purpose :
A prior study conducted at Memorial Sloan-Kettering showed that a combination of the drugs dexamethasone, doxorubicin, and thalidomide was effective and safe for reducing or eliminating multiple myeloma. In this study, researchers want to see if adding the drug bortezomib (VELCADETM) to this combination can help completely eliminate myeloma in more patients. The combination will be assessed in patients with myeloma that is untreated and considered to be high-risk, or has persisted despite standard treatment.
Bortezomib is approved for the treatment of multiple myeloma after prior treatments have failed. Doxorubicin and dexamethasone are drugs approved for the treatment of myeloma, and have been used for many years in many patients. Thalidomide, a medicine first used in the late 1950s to combat the nausea some women experience in the first trimester of pregnancy, was found to cause birth defects and was later banned. In the late 1990s, however, cancer researchers discovered that thalidomide could be used to treat myeloma.
In this study, patients will first receive bortezomib, pegylated liposomal doxorubicin (Doxil), and dexamethasone, followed by thalidomide and dexamethasone with or without bortezomib.
Patients will also be evaluated by a total body scan, called a PET scan, in order to identify the extent of their myeloma both before and after treatment. At the time of their initial bone marrow studies, patients will also be given the opportunity to contribute samples of their myeloma cells for basic research into the biology of the disease.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of stage 2 or 3 multiple myeloma that is high-risk (as determined by blood tests or by spread beyond the bones) or has persisted despite standard treatment.
- Patients may not have had more than two prior regimens of initial chemotherapy for myeloma. Patients may not have had prior treatment with bortezomib.
- Because thalidomide is known to be harmful to the developing fetus, participants in their reproductive years must be willing to use adequate contraception during the study period.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Heather Landau at 212-639-8808.
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