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Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Retreatment, VELCADE

Eligibility Criteria

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

Inclusion Criteria: Voluntary written informed consent with the understanding that the consent may be w/d by the patient at any time w/o prejudice to future medical care. Patient previously diagnosed with Multiple Myeloma (MM). Patient previously tolerated 0.7, 1.0, or 1.3 mg/m2/dose of VELCADE alone or therapy combination and had at least a greater/equal 50% reduction in M-Protein upon completion of VELCADE therapy. The DOR prior to VELCADE greater/equal 4 months for the patient population. It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol. Patient has a Karnosfsky performance status greater/equal 60%. Patient has a life-expectancy greater than 3 months. Patient has laboratory values (defined in protocol) within 14 days before enrollment. Exclusion Criteria: Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE. Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE. Patients who achieved a CR or PR but relapsed while on therapy. Patient had major surgery w/in 2 wks before enrollment. Patient has a Hx of allergic reaction to compounds containing boron or mannitol. Patient has peripheral sensory neuropathy of Grade 2 w/pain or greater intensity. Patient has cardiac amyloidosis. Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or pysychiatric illness. Patient is known to be human immunodeficiency virus (HIV)+. Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. Patient has an active systemic infection requiring treatment. Female patient is pregnant or breast-feeding. Confirmation must be established by a negative serum B-hCG. Patient is currently enrolled in another clinical research study.

Sites / Locations

  • Sinai Hospital of Baltimore

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 18, 2005
Last Updated
February 7, 2008
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00257114
Brief Title
Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability
Official Title
Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
Multiple myeloma represents the second most common hematological malignancy.VELCADE is a small molecule to treat human malignancies. Its anti-neoplastic effect invovles several distinct mechanisms including inhibition of cell growth. Patients who have relapsed or are refractory to therapy, the standard of care is now VELCADE based on the results of previous clinical trials.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary written informed consent with the understanding that the consent may be w/d by the patient at any time w/o prejudice to future medical care. Patient previously diagnosed with Multiple Myeloma (MM). Patient previously tolerated 0.7, 1.0, or 1.3 mg/m2/dose of VELCADE alone or therapy combination and had at least a greater/equal 50% reduction in M-Protein upon completion of VELCADE therapy. The DOR prior to VELCADE greater/equal 4 months for the patient population. It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol. Patient has a Karnosfsky performance status greater/equal 60%. Patient has a life-expectancy greater than 3 months. Patient has laboratory values (defined in protocol) within 14 days before enrollment. Exclusion Criteria: Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE. Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE. Patients who achieved a CR or PR but relapsed while on therapy. Patient had major surgery w/in 2 wks before enrollment. Patient has a Hx of allergic reaction to compounds containing boron or mannitol. Patient has peripheral sensory neuropathy of Grade 2 w/pain or greater intensity. Patient has cardiac amyloidosis. Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or pysychiatric illness. Patient is known to be human immunodeficiency virus (HIV)+. Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. Patient has an active systemic infection requiring treatment. Female patient is pregnant or breast-feeding. Confirmation must be established by a negative serum B-hCG. Patient is currently enrolled in another clinical research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Walters, M.D.
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability

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