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

• Conditions: Multiple Myeloma

• Registration Number: NCT01314625
• Lead Sponsor: University of Arkansas

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).

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16
• Primary Completion: 2012-06
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States