Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Dana-Farber Cancer Institute.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
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
First received: September 8, 2005
Last updated: December 20, 2007
Last verified: December 2007
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma |
Resource links provided by NLM:
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:
Detailed Description:
-
Drug: bortezomib
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.
Other Name: Velcade
- 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
No publications provided
| Responsible Party: | Paul Richardson, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00153920 History of Changes |
| Other Study ID Numbers: | 03-328 |
| Study First Received: | September 8, 2005 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
multiple myeloma Velcade bortezomib |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013