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Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
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

Summary

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.

Clinical Details

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

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

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

Secondary outcome:

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.

Detailed description:

- 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

enrollment

- 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

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, 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

Additional Information

Starting date: December 2003
Last updated: October 15, 2013

Page last updated: August 23, 2015

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