Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients

• ClinicalTrials.gov Identifier: NCT01720043
• Recruitment Status: Terminated
• First Posted: November 1, 2012
• Results First Posted: July 7, 2017
• Last Update Posted: September 5, 2017
• Sponsor: University of Utah
• Information provided by (Responsible Party): University of Utah

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Velcade	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients
• Study Start Date: July 2013
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: July 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: All participants; All participants enrolled	Drug: Velcade; Single dose of Velcade (1.0-1.3 mg/m2 dose); Other Name: Bortezomib

Outcome Measures

Primary Outcome Measures :

1. Efficacy of Velcade [ Time Frame: 48 hours ]
   Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.

Eligibility Criteria

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

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Contacts and Locations

Locations

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

Investigators

• Principal Investigator: Tibor Kovacsovics, MD; Huntsman Cancer Institute

More Information

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT01720043
• Other Study ID Numbers: HCI57748
• First Posted: November 1, 2012
• Results First Posted: July 7, 2017
• Last Update Posted: September 5, 2017
• Last Verified: August 2017

Keywords provided by University of Utah:

multiple myeloma

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bortezomib; Antineoplastic Agents