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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00216151
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:
* Presence of bone marrow clonal plasma cells (more than 10%)
* Presence of an M-protein in serum and/or urine (no concentration specified)
* Serum calcium \< 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey
* No symptoms of hyperviscosity, amyloidosis or recurrent infection
* Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration
* Negative pregnancy test
Exclusion Criteria:
* No previous treatment with bisphosphonates
* No disorders of the parathyroid or thyroid glands
* No current breastfeeding
* No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason \< grade 7 prostate cancers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00216151
Study Brief:
Protocol Section:
NCT00216151