A Pilot Study Evaluating Hypotension and Autonomic Nervous System Dysfunction After Therapy With Bortezomib-containing Regimens in Subjects With Multiple Myeloma
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).
Observational Model: Case-Only, Time Perspective: Prospective
To determine whether the orthostatic hypotension reported among subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic nervous system (ANS).
Patient symptoms that are most disabling after Bortezomib treatment appear to be those caused by autonomic instability/dysfunction such as orthostatic intolerance, vasomotor changes with pallor, sweating, gut hypermotility and sensory peripheral neuropathy. Although these symptoms are not specific, clinical wisdom dictates that the autonomic nervous system (ANS) be investigated first. However, the mechanism (s) underlying the orthostatic hypotension and other Velcade-associated toxicities remain unclear. We plan to evaluate the exact cause behind these severe adverse events.
Elias Anaissie, MD
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|