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



Status:Completed
Conditions:Blood Cancer, Cardiology, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Hematology, Oncology
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:March 2011
End Date:August 2012
Contact:Naveen sanath kumar, MD, MHSA
Email:nsanathkumar@uams.edu
Phone:5016811972

Use our guide to learn which trials are right for you!

A Pilot Study Evaluating Hypotension and Autonomic Nervous System Dysfunction After Therapy With Bortezomib-containing Regimens in Subjects With Multiple Myeloma

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).

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).

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.
We found this trial at
2
sites
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials