Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: bortezomib (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Dana-Farber Cancer Institute
Official(s) and/or principal investigator(s):
Paul Richardson, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple
myeloma in patients who have received at least two prior therapies and have demonstrated
disease progression on the last therapy. This study will determine if Velcade is effective
in treating patients with multiple myeloma that have had no prior treatment for the disease.
We will also use whole-genome scanning to identify drug response biomarkers in bone marrow
samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and
after treatment with Velcade.
Official title: Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the objective response to Velcade (bortezomib) alone in patients with newly diagnosed multiple myeloma.
To evaluate the safety of bortezomib in patients with newly diagnosed multiple myeloma
evaluate time to disease progression following bortezomib treatment
assess the frequency and severity of peripheral neuropathy in this patient population.
- 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
Minimum age: 18 Years.
Maximum age: N/A.
- Diagnosis of multiple myeloma based upon standard criteria
- Measurable disease, defined as a monoclonal immunoglobulin spike on serum
electrophoresis of > 1 g/dl and/or urine monoclonal immunoglobulin spike of > 200mg/24
- Karnofsky performance status of > 60
- Hemoglobin > 8. 0 g/dL
- AST (SGOT) < 3 x ULN
- ALT < 3 x ULN
- Total bilirubin < 2 x ULN
- Is infertile or is practicing an adequate form of contraception
- 18 years of age or older
- Prior treatment with systemic chemotherapy
- Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal
protein and skin changes
- Plasma cell leukemia
- Calculated or measured creatinine clearance < 30 mL/minute within 14 days of
- Grade 2 or greater peripheral neuropathy
- Hypersensitivity to bortezomib, boron or mannitol
- Severe hypercalcemia
- HIV positive
- Known active hepatitis B or C
- New York Hospital Association Class III or IV heart failure
- Second malignancy requiring concurrent treatment
- Other serious medical or psychiatric illness
- Pregnant women
- Dialysis dependent patients
Locations and Contacts
Emory Winship Cancer Institute, Atlanta, Georgia 30322, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States
Roswell Park Cancer Institute, Buffalo, New York 04263, United States
Memorial Sloan-Kettering Cancer Center, New York City, New York 10021, United States
Starting date: December 2003
Ending date: September 2008
Last updated: December 20, 2007