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

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00257114
First received: November 18, 2005
Last updated: February 7, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Drug: bortezomib
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability

Resource links provided by NLM:

Drug Information available for: Bortezomib
U.S. FDA Resources

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patient previously diagnosed with Multiple Myeloma (MM).
  3. 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.
  4. It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol.
  5. Patient has a Karnosfsky performance status greater/equal 60%.
  6. Patient has a life-expectancy greater than 3 months.
  7. Patient has laboratory values (defined in protocol) within 14 days before enrollment.

Exclusion Criteria:

  1. Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE.
  2. Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE.
  3. Patients who achieved a CR or PR but relapsed while on therapy.
  4. Patient had major surgery w/in 2 wks before enrollment.
  5. Patient has a Hx of allergic reaction to compounds containing boron or mannitol.
  6. Patient has peripheral sensory neuropathy of Grade 2 w/pain or greater intensity.
  7. Patient has cardiac amyloidosis.
  8. Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or pysychiatric illness.
  9. Patient is known to be human immunodeficiency virus (HIV)+.
  10. Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
  11. Patient has an active systemic infection requiring treatment.
  12. Female patient is pregnant or breast-feeding. Confirmation must be established by a negative serum B-hCG.
  13. Patient is currently enrolled in another clinical research study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257114

Locations
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Ian Walters, M.D. Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00257114     History of Changes
Other Study ID Numbers: C05004
Study First Received: November 18, 2005
Last Updated: February 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Millennium Pharmaceuticals, Inc.:
Multiple Myeloma
Retreatment
VELCADE

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013