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Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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
(days 12-21).

- 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.

Inclusion Criteria:

- 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 hours.

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the objective response to Velcade (bortezomib) alone in patients with newly diagnosed multiple myeloma.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Paul Richardson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

October 2008

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • Velcade
  • bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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