A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction in Multiple Myeloma (MM) Patients
Recruitment status was: Recruiting
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Pilot Study Evaluating Hypotension and Autonomic Nervous System Dysfunction After Therapy With Bortezomib-containing Regimens in Subjects With Multiple Myeloma|
- To determine whether the orthostatic hypotension reported among subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic nervous system (ANS). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
- To gather pilot data on the incidence of autonomic dysfunction in patients with Multiple Myeloma prior to treatment with Bortezomib. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Bortezomib (Velcade), a particularly effective agent against multiple myeloma, is associated with a 13 % incidence of hypotension.
A recent analysis of over 170 subjects enrolled in UAMS protocol for therapy of newly diagnosed myeloma focused on three Velcade-containing cycles (two induction cycles and one consolidation with VDT-PACE (V=Velcade). A 9-19 % incidence of hypotension was observed. In addition, these cycles were complicated by diarrhea and sensory dysesthesias.
We plan to calculate the incidence of Hypotension in these pt's treated with Bortezomib
- To characterize the changes in the ANS including the fluctuations in blood pressure (hypotension /hypertension) associated with bortezomib. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Although orthostatic blood pressure (BP) measurements were not routinely obtained in our study, analysis of daily BP values during Velcade-containing cycles revealed that > 60% of subjects exhibited BP lability with variations in their BP measurements by >20mm systolic and >10mm diastolic on successive days during the course of therapy. A subset of these subjects presented with severe symptoms, particularly orthostatic hypotension, and at times requiring hospitalization.
We plan to investigate the ANS changes with a serial orthostatic measurement after Bortezomib therapy
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
- To gather pilot data on the incidence of autonomic dysfunction in patients with Multiple Myeloma prior to treatment with Bortezomib.
- To characterize the changes in the ANS including the fluctuations in blood pressure (hypotension /hypertension) associated with bortezomib.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314625
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Elias Anaissie, MD||Principal Investigator|