Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability
This study has been completed.
Information provided by:
Millennium Pharmaceuticals, Inc.
First received: November 18, 2005
Last updated: February 7, 2008
Last verified: February 2008
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.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability
| Primary Completion Date:
||March 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00257114
|Sinai Hospital of Baltimore
|Baltimore, Maryland, United States, 21215 |
Millennium Pharmaceuticals, Inc.
||Ian Walters, M.D.
||Millennium Pharmaceuticals, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 18, 2005
||February 7, 2008
||United States: Institutional Review Board
Keywords provided by Millennium Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action