Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

Official title:

Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01720043
• Other study ID #: HCI57748
• Status: Terminated
• Phase: Phase 2
• First received: October 30, 2012
• Last updated: December 8, 2016
• Start date: July 2013
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Velcade
Single dose of Velcade (1.0-1.3 mg/m2 dose)

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Velcade	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	2 days	No