Status:
TERMINATED
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial studies how well cryocompression therapy works in reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Peripheral neuropathy (nerve pain or tingling in hands...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the feasibility of daily cryocompression therapy in multiple myeloma patients with bortezomib-induced peripheral neuropathy (BIPN). SECONDARY OBJECTIVES: I. To exam...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03870451
Start Date
November 1 2019
End Date
February 10 2023
Last Update
October 26 2024
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157