Recruiting

Observational Study

Sponsor:

University of Arkansas

Code:

NCT01314625

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Multiple Myeloma

Study ID

NCT01314625

Start date

Mar, 2011

Status verified date

May, 2012

Completion date

Aug, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

one arm

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 ]

Central Contacts and Locations

Central contacts

Naveen sanath kumar, MD, MHSA

5016811972nsanathkumar@uams.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Naveen Sanath Kumar, MD, MHSA

501-681-1972nsanathkumar@uams.edu

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

naveen sanathkumar, MD, MHSA

501-526-6990nsanathkumar@uams.edu

More Information

Sponsor

University of Arkansas

Last update posted

May 16, 2012

Last verified

May, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2012-05-16.