Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Velcade
Intervention description: Single dose of Velcade (1.0-1.3 mg/m2 dose)
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma

Summary:

      To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours
      after infusion in patients with multiple myeloma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with the diagnosis of multiple myeloma

          -  Patients should have not have received VELCADE for at least 2 weeks before receiving
             treatment with VELCADE for platelet aggregation testing

          -  Patients are to be instructed not to take aspirin or ibuprofen 7-10 days prior to the
             platelet aggregations testing.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

          -  Female subject is either postmenopausal for at least 1 year before the screening
             visit, is surgically sterilized or if they are of childbearing potential, agree to
             practice 2 effective methods of contraception from the time of signing the informed
             consent form through 30 days after the last dose of VELCADE, or agree to completely
             abstain from heterosexual intercourse.

          -  Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to
             1 of the following: practice effective barrier contraception during the entire study
             treatment period and through a minimum of 30 days after the last dose of study drug,
             or completely abstain from heterosexual intercourse.

        Exclusion Criteria:

          -  Patients who have received Velcade within 2 weeks prior to study registration

          -  Patient has a platelet count of < 150,000 within 7 days before enrollment.

          -  Patient has an absolute neutrophil count of < 1000 within 7 days before enrollment.

          -  Patient has > 1.5 x ULN Total Bilirubin

          -  Patient has > Grade 2 peripheral neuropathy

          -  Patient had myocardial infarction within 6 months prior to enrollment or has New York
             Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities. Prior to study entry, any ECG
             abnormality at screening must be documented by the investigator as not medically
             relevant.

          -  Currently receiving medication with Coumadin, heparin, low molecular weight heparin,
             or NSAIDS. Concomitant use with any of these medications must be discontinued within
             two weeks prior to beginning protocol treatment.

          -  Patient has hypersensitivity to VELCADE, boron, or mannitol.

          -  Female subject is pregnant or lactating. Confirmation that the subject is not pregnant
             must be established by a negative serum pregnancy test result obtained during
             screening. Pregnancy testing is not required for postmenopausal or surgically
             sterilized women.

          -  Female patients who are lactating or have a positive serum pregnancy test during the
             screening period, or a positive urine pregnancy test on Day 1 before first dose of
             study drug, if applicable.

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          -  Diagnosed or treated for another malignancy within 2 years of enrollment, with the
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
             the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

          -  Participation in clinical trials with other investigational agents not included in
             this trial, within 14 days of the start of this trial and throughout the duration of
             this trial.

          -  Radiation therapy within 3 weeks before randomization. Enrollment of subjects who
             require concurrent radiotherapy (which must be localized in its field size) should be
             deferred until the radiotherapy is completed and 3 weeks have elapsed since the last
             date of therapy.