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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01859234
Eligibility Criteria:
Inclusion Criteria:
Patients with relapsing multiple myeloma according to international defined guidelines:
Relapse after having achieved complete remission:
1. Reappearance of paraprotein
2. More than 5% plasma cells in bone marrow.
3. New lytic lesions or progression of old lesions.
4. New hypercalcaeamia.
Relapse after having achieved partial remission
1. Increases of paraprotein with more than 25%
2. Increase of urine paraprotein with more than 25%
3. Increase of plasma cells in bone marrow with 10%
4. New lytic lesions or progression of old lesions
5. New hypercalcaemia -
Exclusion Criteria:
Radiotherapy in the last 3 months.
* Ineligible to lay supine during the PET scan.
* Age ≤18 years.
* Pregnancy.
* Claustrophobia
* Severe kidney dysfunction; serum-creatinine ≥250 µM
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01859234
Study Brief:
Protocol Section:
NCT01859234