Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
- Patients will receive intravenous Velcade on a 3 week dosing cycle. Velcade will be
given twice a week for 2 weeks (on days 1,4,8 and 11) followed by a 10 day rest period
- On the days patients receive Velcade a physical exam, vital signs, and blood tests will
be performed. A neurotoxicity-directed questionnaire will be completed once during
each cycle of therapy.
- A patient may undergo up to eight 3-week dosing cycles. During the dosing phase, if
after two cycles of dosing, tests indicate progressive disease the patient will be
removed from the study.
- A complete response means that all traces of the disease have disappeared: there are no
abnormal proteins in the blood or urine; no traces of abnormal cells in bone marrow or
any other place; and no worsening of bone tumors are found. Confirmation of this will
be obtained at least 6 weeks after initial testing by a bone marrow biopsy.
- An end of dosing phase visit will occur 30 days after the last study dose; or 2 dosing
cycles following the time it is confirmed that there is complete response; or at the
time it is confirmed that the disease has worsened.
- After the end of the study visits, patients will be asked to participate in follow-up
telephone calls every 6 weeks.
- Whole-genome scanning and nerve fiber studies are optional research studies for
patients enrolled in the dosing phase. The whole-genome scanning portion involves
collection of a bone marrow biopsy at the start and end of the study. The nerve fiber
study involves skin biopsies at the next study visit after neuropathy is reported and
at the end of the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the objective response to Velcade (bortezomib) alone in patients with newly diagnosed multiple myeloma.
Paul Richardson, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Emory Winship Cancer Institute||Atlanta, Georgia 30322|