Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability
Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedFebruary 11, 2008
February 1, 2008
November 18, 2005
February 7, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ian Walters, M.D.
Millennium Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Primary Completion
March 1, 2007
Last Updated
February 11, 2008
Record last verified: 2008-02