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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT04770402
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
2. Age ≥ 18 years at the time of consent
3. Subject has diagnosis of Multiple Myeloma (any stage) per Investigator
4. Currently being treated with bortezomib or bortezomib-combination chemotherapy
5. ECOG Performance status of 0-3
6. Life expectancy of ≥ 12 weeks
7. Chemotherapy-Induced Peripheral Neuropathy score of ≥ 2
8. No planned hospital admission in the next 10 weeks
9. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
Exclusion Criteria:
1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
2. Subjects with neuropathy pain as a result of spinal injury or vertebral compression fractures
3. Subjects with needle phobia
4. Previous diagnosis of amyloidosis or POEMS syndrome
5. Local infection at or near the planned acupuncture sites (see Appendix A)
6. Subjects with metastatic involvement of the nervous system/active central nervous system disease
7. Plan to receive Healing Touch or Oncology Massage during study
8. Have received acupuncture within 30 days prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04770402
Study Brief:
Protocol Section:
NCT04770402