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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257114
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : February 11, 2008
Information provided by:
Millennium Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: bortezomib Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257114

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

Layout table for additonal information Identifier: NCT00257114     History of Changes
Other Study ID Numbers: C05004
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: February 11, 2008
Last Verified: February 2008

Keywords provided by Millennium Pharmaceuticals, Inc.:
Multiple Myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents