Multiple Myeloma Clinical Trial
Official title:
A Multi-Institutional Phase I/II Study of Revlimid® (Lenalidomide), Velcade® (Bortezomib), Dexamethasone, and Doxil®, (RVDD) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
This research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly diagnosed multiple myeloma.
During the Phase I portion of this clinical trial, the doses of Revlimid® and Doxil® will be
increased until the best and safest amount (or dose) is identified in combination with
Velcade® and Dexamethasone. "Investigational" means that the drug combination is still being
studied and that research doctors are trying to find out more about it such as the safest
dose to use, the side effects it may cause and how effective the Velcade®, Doxil®,
Dexamethasone and Revlimid® investigational combination is for treating newly diagnosed
multiple myeloma. In this clinical trial we are looking for the highest dose of the
combination that can be given safely and see how well it works as a combination in newly
diagnosed patients.
Each of these drugs, Velcade®, Doxil®, Dexamethasone and Revlimid® are approved by the FDA
(U.S. Food and Drug Administration). They have not been approved in this combination for use
for your type of cancer or any other type of cancer. Velcade® is currently approved by the
United States Food and Drug Administration (US FDA) for the treatment of multiple myeloma
patients who have received at least one prior therapy. Doxil® has recently been approved by
the US FDA for multiple myeloma in combination with Velcade® in patients who have not
previously received Velcade® and have received at least one prior therapy. Dexamethasone is
commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.
Revlimid® is currently approved by the US FDA in combination with dexamethasone for the
treatment of patients with multiple myeloma who have received at least 1 prior therapy.
After the Phase I clinical trial defines the safest doses of Velcade®, Doxil®, Dexamethasone
and Revlimid® that can be taken together, the research study will move on to its second
portion, a Phase II clinical trial. The Phase II portion of the clinical trial will test the
clinical effectiveness of the best dose combination of the four drugs.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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