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

This study is currently recruiting participants.
Verified May 2012 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01314625
First received: March 10, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Phase
Multiple Myeloma
 Phase 3

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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



Estimated Enrollment: 10
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)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314625

Contacts
Contact: Naveen sanath kumar, MD, MHSA 5016811972 nsanathkumar@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Naveen Sanath Kumar, MD, MHSA     501-681-1972     nsanathkumar@uams.edu    
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: naveen sanathkumar, MD, MHSA     501-526-6990 ext 8924     nsanathkumar@uams.edu    
Sub-Investigator: Naveen sanath kumar, MD, MHSA            
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Elias Anaissie, MD Principal Investigator
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01314625     History of Changes
Other Study ID Numbers: UAMS 2009-50
Study First Received: March 10, 2011
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypotension
Multiple Myeloma
Neoplasms, Plasma Cell
Vascular Diseases
Cardiovascular Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013