Phase III Randomized Trial of Thalidomide/Dexamethasone vs VAD as Induction Chemotherapy for Newly Diagnosed Myeloma Patients and Evaluation of the Effects of Zoledronate on Chemotherapy Induced Apoptosis and Antigen Presentation.
If the patients are randomized to receive VAD they will have an intravenous catheter
inserted. The chemotherapy drugs, vincristine and adriamycin will be administered by
continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is
considered one "cycle" of therapy. The patients will receive 4 to 6 cycles of therapy. The
dexamethasone will be taken in a pill form. During the first 2 cycles it will be taken on
days 1-4, 9-12, and 17-20. For all other cycles dexamethasone will be taken only on days
Patients who are randomized to receive thalidomide and dexamethasone will take thalidomide
orally once every day in the evening for 4 to 6 months. The dexamethasone will be taken in a
pill form. During the first 2 cycles it will be taken on days 1-4, 9-12, and 17-20. For all
other cycles dexamethasone will be taken orally on days 1-4.
The dose of thalidomide will start at 100 mg per day and will be increased slowly to 200 mg
over several weeks. All patients taking thalidomide will also be required to comply with
the System of Thalidomide Education and Prescribing Safety program (S.T.E.P.S.). This is a
program of education and safety related to the use of Thalidomide and the prevention of
pregnancy. You will be required to sign a separate consent indicating that they understand
and agree with the guidelines. Women of child bearing potential will be required to have a
negative pregnancy test within 24 hours of starting thalidomide. This will be repeated every
week for 4 weeks and then monthly for the duration of thalidomide therapy. Women with
irregular menstruation will have the pregnancy test done every 2 weeks.
All patients will receive zoledronate by intravenous infusion, over at least 15 minutes
monthly (either on the first or fifteenth day of each month). The schedule will be randomly
selected and the patient will not have a choice on which day you receive the zoledronate.
Supportive medications (all study patients):
During each cycle of therapy, additional medications will be given to help reduce the side
effects of treatment. Patients enrolled in this study will be prescribed supportive
medications such as: 1) stomach acid suppressors to prevent stomach ulcers, and 2)
antibiotics to protect against infections while receiving dexamethasone, 3) "blood thinners"
to reduce the development of blood clots. This medicine can be taken as pills or shots under
the skin.If the subject will receive VAD then they will be on a preventative dose of blood
thinner. If they are to receive thalidomide/dexamethasone you will be on a higher dose of
blood thinner. Other medications such as those used to prevent nausea, diarrhea and
medications for low blood counts may also be given as needed.
At the end of 4 months, those patients who are eligible, will proceed to have high-dose
chemotherapy and stem cell transplantation. These patients will then be taken off active
Patients not eligible for transplant will continue with chemotherapy or thalidomide and
dexamethasone for 2 additional months (total of 6 months) and will then be taken off active
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Level of Response Observed
Compare response rates of thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed MM. The Blade (15) criteria for remission in multiple myeloma will be used to assess response to VAD and thalidomide/dexamethasone therapy. Any improvement that meets the criteria for complete response (CR), partial response (PR), or minimal response (MR) will be considered a response for the purposes of calculating the primary endpoint. Progressive disease (PD) or relapse from CR will be considered treatment failure in determining the primary endpoint.
6 Months or until start of transplant for transplant candidates
Melissa Alsina, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|Morton Plant Hospital||Clearwater, Florida 33756|
|Watson Clinic||Lakeland, Florida 33805|
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|
|Fawcett Memorial Hospital||Port Charlotte, Florida 33952|