Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT03870451
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System \[ISS\] stage).
* Clinical symptoms of bortezomib-induced peripheral neuropathy as measured by the NCI-CTCAE.
Cohort 1: Patients with clinically documented CTCAE grade greater than or equal 2 neuropathy.
Cohort 2: Patients with clinically documented CTCAE grade 1-2 neuropathy.
• Currently or previously received bortezomib-containing regimen
Cohort 1: Patients who have previously received a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen.
Cohort 2: Patients who are currently receiving a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen.
* Age must be greater than or equal to 18 years.
* Eastern Cooperative Oncology Group (ECOG) =\< 4.
* Life expectancy \>= 6 months.
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.
Exclusion Criteria:
* Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of bortezomib therapy.
* Other explanatory etiology for neuropathy.
* Presumptive evidence of congestive heart failure.
* Current deep vein thrombosis or pulmonary embolism (diagnosed within the past 6 months).
* Current pulmonary edema.
* Unable to provide accurate medical history.
* Pregnant women are excluded from this study because they will not be receiving myeloma standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria.
* Current or previously documented inflammatory phlebitis; thrombophlebitis; decompensated cardiac insufficiency; arterial dysregulation; erysipelas; carcinoma or carcinoma metastasis in the affected extremity; decompensated hypotonia; venous or arterial occlusive disease; or Raynaud's disease;
* Current monoclonal gammopathy of undetermined significance (MGUS), Waldenstroms macroglobulinemia, or Castleman disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03870451
Study Brief:
Protocol Section:
NCT03870451