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A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE

Primary Purpose

Multiple Myeloma

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Bortezomib
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Multiple Myeloma focused on measuring Relapsed or Refractory

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Major Criteria: Plasmacytomas on tissue biopsy Bone marrow plasmacytosis (> 30% plasma cells) Monoclonal IgG is > 3.5 g/dL or IgA is > 2.0 g/dL; kappa or lambda light chain excretion is > 1 g/day on a 24 hour urine sample. Minor criteria: Bone marrow plasmacytosis (10 to 30%) Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria. Lytic bone lesions Other Eligibility Requirements: Patient is not eligible for Millennium Study M34101-039. Patient has received 4 or more lines of therapy for multiple myeloma and, in the investigator's opinion, currently needs therapy because of relapsed or progressive disease. Patient is of legal consenting age, as defined by local regulations. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care. Female patients must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control throughout the study. Male patients must agree to use an acceptable method of birth control throughout the study. Patient has a Karnofsky performance status of greater than or equal to 60%. Patient meets pretreatment laboratory criteria at and within 14 to 21 days before Baseline (Day 1 of Cycle 1, before study drug administration). Exclusion Criteria: Patient progressed while receiving VELCADE previously in a clinical trial. Patient has been treated in Millennium Study M34101-039. Patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 1 week before enrollment in the study. Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment in the study. Patient received immunotherapy or antibody therapy within 4 weeks before enrollment. Patient had major surgery with 4 weeks before enrollment (kyphoplasty isn't considered major surgery). Patient has a history of allergic reactions due to compounds containing boron or mannitol. Patient has peripheral neuropathy of Grade 2 or greater, as defined by the National Cancer Institute Common Toxicity Criteria (NCI CTC). Patient has a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiogram shows evidence of acute ischemia or active conduction system abnormalities. Patient has cardiac amyloidosis Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment. Patient is known to be infected with human immunodeficiency virus (HIV positive). Patient is known to be hepatitis B positive or has active hepatitis C infection. Patient has an active systemic infection requiring treatment. Female patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant is required. Pregnancy testing is not required for post-menopausal or surgically sterilized patients.

Sites / Locations

  • Michael Meshad, Oncology Center
  • Henry Ford Health System
  • Toledo Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 7, 2003
Last Updated
February 13, 2007
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00063791
Brief Title
A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE
Official Title
An Open-Labeled, Randomized Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE in Patients With Relapsed Multiple Myeloma Who Have Failed Four or More Lines of Therapy
Study Type
Expanded Access

2. Study Status

Record Verification Date
July 2003
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to give patients who have had 4 or more prior lines of therapy for multiple myeloma access to VELCADE. The study is for patients who are not eligible for other clinical trials with VELCADE and for who VELCADE would otherwise not be available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed or Refractory

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bortezomib

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major Criteria: Plasmacytomas on tissue biopsy Bone marrow plasmacytosis (> 30% plasma cells) Monoclonal IgG is > 3.5 g/dL or IgA is > 2.0 g/dL; kappa or lambda light chain excretion is > 1 g/day on a 24 hour urine sample. Minor criteria: Bone marrow plasmacytosis (10 to 30%) Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria. Lytic bone lesions Other Eligibility Requirements: Patient is not eligible for Millennium Study M34101-039. Patient has received 4 or more lines of therapy for multiple myeloma and, in the investigator's opinion, currently needs therapy because of relapsed or progressive disease. Patient is of legal consenting age, as defined by local regulations. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care. Female patients must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control throughout the study. Male patients must agree to use an acceptable method of birth control throughout the study. Patient has a Karnofsky performance status of greater than or equal to 60%. Patient meets pretreatment laboratory criteria at and within 14 to 21 days before Baseline (Day 1 of Cycle 1, before study drug administration). Exclusion Criteria: Patient progressed while receiving VELCADE previously in a clinical trial. Patient has been treated in Millennium Study M34101-039. Patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 1 week before enrollment in the study. Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment in the study. Patient received immunotherapy or antibody therapy within 4 weeks before enrollment. Patient had major surgery with 4 weeks before enrollment (kyphoplasty isn't considered major surgery). Patient has a history of allergic reactions due to compounds containing boron or mannitol. Patient has peripheral neuropathy of Grade 2 or greater, as defined by the National Cancer Institute Common Toxicity Criteria (NCI CTC). Patient has a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiogram shows evidence of acute ischemia or active conduction system abnormalities. Patient has cardiac amyloidosis Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment. Patient is known to be infected with human immunodeficiency virus (HIV positive). Patient is known to be hepatitis B positive or has active hepatitis C infection. Patient has an active systemic infection requiring treatment. Female patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant is required. Pregnancy testing is not required for post-menopausal or surgically sterilized patients.
Facility Information:
Facility Name
Michael Meshad, Oncology Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Toledo Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States

12. IPD Sharing Statement

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A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE

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