Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
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 (Responsible Party):
Paul G. Richardson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00153920
First received: September 8, 2005
Last updated: October 15, 2013
Last verified: October 2013
  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: 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: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bortezomib
Participants will receive intravenous bortezomib 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).
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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

Publications:
Responsible Party: Paul G. Richardson, MD, Principle Investigator, 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: October 15, 2013
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014