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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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).


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine whether the orthostatic hypotension reported among subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic nervous system (ANS).

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Elias Anaissie, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Principal Investigator

Authority:

United States: Institutional Review Board

Study ID:

UAMS 2009-50

NCT ID:

NCT01314625

Start Date:

March 2011

Completion Date:

August 2012

Related Keywords:

  • Multiple Myeloma
  • Hypotension
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205