A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction in Multiple Myeloma (MM) Patients

NCT ID: NCT01314625

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-08-31

Brief Summary

The purpose of this study is to determine whether the orthostatic hypotension reported among subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic nervous system (ANS).

Detailed Description

1. To gather pilot data on the incidence of autonomic dysfunction in patients with Multiple Myeloma prior to treatment with Bortezomib.

2. To characterize the changes in the ANS including the fluctuations in blood pressure (hypotension /hypertension) associated with bortezomib.

3. To determine the duration of the ANS dysfunction if present.

This is not a treatment study, only an evaluation of the autonomic nervous system (ANS) among subjects receiving antimyeloma therapy which includes bortezomib (Velcade).

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

one arm

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects with Active Multiple Myeloma who are scheduled to be treated with Bortezomib-containing regimens.
• Subjects must have signed an IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.

Exclusion Criteria

• Subjects with unstable cardiovascular disease. Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
• Subjects unable to perform the Valsalva maneuver such as patients with clinically significant aortic stenosis, glaucoma or retinopathy.
• Subjects receiving Selective Serotonin Reuptake Inhibitors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elias Anaissie, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status: RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Naveen sanath kumar, MD, MHSA

Role: CONTACT

nsanathkumar@uams.edu

5016811972

Facility Contacts

Naveen Sanath Kumar, MD, MHSA

Role: primary

nsanathkumar@uams.edu

501-681-1972

naveen sanathkumar, MD, MHSA

Role: primary

nsanathkumar@uams.edu

501-526-6990 ext. 8924

Other Identifiers

UAMS 2009-50

Identifier Type: -

Identifier Source: org_study_id