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

University of Arkansas

Status: Unknown

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Other

Identifiers

NCT01314625

UAMS 2009-50

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

one arm