Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Massachusetts General Hospital Brigham and Women's Hospital Roswell Park Cancer Institute Emory University Memorial Sloan-Kettering Cancer Center Millennium Pharmaceuticals, Inc.
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00153920

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: bortezomib	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To evaluate the objective response to Velcade (bortezomib) alone in patients with newly diagnosed multiple myeloma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of bortezomib in patients with newly diagnosed multiple myeloma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
evaluate time to disease progression following bortezomib treatment [ Time Frame: TBD ] [ Designated as safety issue: No ]
assess the frequency and severity of peripheral neuropathy in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	66
Study Start Date:	December 2003
Estimated Study Completion Date:	September 2008
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously twice a week for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12-21) for up to eight 3-week treatment cycles.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153920

Locations

United States, Georgia
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 04263
Memorial Sloan-Kettering Cancer Center
New York City, New York, United States, 10021

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Brigham and Women's Hospital

Roswell Park Cancer Institute

Emory University

Memorial Sloan-Kettering Cancer Center

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Paul Richardson, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Paul Richardson, MD )
Study ID Numbers:	03-328
Study First Received:	September 8, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00153920
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

multiple myeloma
Velcade
bortezomib

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009