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Hemostatic Effects of VELCADEĀ®* Treatment in Multiple Myeloma Patients

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Hemostatic Effects of VELCADEĀ®* Treatment in Multiple Myeloma Patients

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not part of normal medical care, with the understanding that consent may be withdrawn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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of Velcade

Outcome Description:

Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at baseline, 24 hours and 48 hours after infusion in patients with multiple myeloma

Outcome Time Frame:

2 days

Safety Issue:


Principal Investigator

Maurizio Zangari, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2013

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Huntsman Cancer Institute Salt Lake City, Utah  84112