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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Arkansas.
Recruitment status was  Recruiting
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

March 10, 2011
May 15, 2012
March 2011
June 2012   (final data collection date for primary 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). [ 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 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: 6 months ] [ 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.

Complete list of historical versions of study NCT01314625 on ClinicalTrials.gov Archive Site
  • 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

  • To gather pilot data on the incidence of autonomic dysfunction in patients with Multiple Myeloma prior to treatment with Bortezomib. [ Time Frame: 6 months ] [ 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: 6 months ] [ 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

Not Provided
Not Provided
 
A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction in Multiple Myeloma (MM) Patients
A Pilot Study Evaluating Hypotension and Autonomic Nervous System Dysfunction After Therapy With Bortezomib-containing Regimens in Subjects With Multiple Myeloma

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).

  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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Multiple Myeloma
Not Provided
one arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
August 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Naveen sanath kumar, MD, MHSA 5016811972 nsanathkumar@uams.edu
United States
 
NCT01314625
UAMS 2009-50
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Elias Anaissie, MD Principal Investigator
University of Arkansas
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP