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Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability


Phase 4
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

Evaluation of VELCADE (Botezomib) for Injection Employed as Re-Treatment for Efficacy, Safety, and Tolerability


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ian Walters, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Institutional Review Board

Study ID:

C05004

NCT ID:

NCT00257114

Start Date:

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Retreatment
  • VELCADE
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Sinai Hospital of BaltimoreBaltimore, Maryland  21225