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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT05775094
Eligibility Criteria:
Inclusion Criteria:
* Documented MM per International Myeloma Working Group diagnostic criteria (evidence of myeloma defining event attributed to underlying plasma cell disorder): i. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma; and ii. Any one or more of the following myeloma defining events:
* Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder:
1. Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL)
2. Renal insufficiency: creatinine clearance \< 40 mL/min or serum creatinine 177µmol/L (\>2 mg/dL)
3. Anemia: hemoglobin \> 2 g/dL below the lower limit of normal, or a hemoglobin value \<10 g/dL
4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT
* Clonal bone marrow plasma cell percentage ≥ 60%; or
* Involved: uninvolved serum free light chain (FLC) ratio ≥ 100 (involved FLC level be ≥ 10 mg/dL; or
* \>1 focal lesion on MRI studies (at least 5 mm in size)
* Presence of lytic bone lesion(s) due to MM based on radiographic evidence with at least one measurable lesion (≥0.5 cm in its largest diameter by computerized tomography \[CT\])
* Postmenopausal female, defined as last menstrual cycle at least 12 months prior to study enrollment
* Must have one of the following:
* osteoporosis on dual X-ray absorptiometry (DXA) scan; or
* fragility fracture of the spine or hip; or
* morphometric spine fracture; or
* osteopenia with elevated risk of fracture (calculated by the FRAX online calculator)
* Within 12 months prior to study entry, ≤ 4 doses of prior intravenous (IV) bisphosphonate with the last dose ≥ 3 months prior to study entry.
* Prior oral bisphosphonates are allowed if the last dose was ≥ 3 months prior to study entry.
* Prior denosumab use is allowed for the following:
* For patients who received ≤ 5 consecutive doses of denosumab with the last dose of denosumab received ≥ 3 months prior to study entry.
* For patients who received ≥ 6 doses of denosumab, IV bisphosphonate should be given at least 1 month after the last dose of denosumab (if the last dose of denosumab was within the past 2 years). Patients are then eligible ≥ 3 months after IV bisphosphonate is received. If ≤ 2 years have elapsed since the last dose of denosumab, IV bisphosphonate is not required, and patients are eligible for the study.
* Signed informed consent form(s). Individuals with impaired decision-making capacity may enroll if legally authorized representatives consent on behalf of individuals with impaired decision-making capacity.
* Ability to comply with all study-related procedures in the investigator's judgment
* 18 years of age or older
Exclusion Criteria:
* Assigned male at birth
* Received teriparatide or other PTH analog use within 12 months prior to study entry
* Receiving concurrent antiresorptive therapy
* History of cardiovascular event (myocardial infarction and/or stroke) within the past 12 months of study entry
* History of non-healed dental or oral surgery
* History of osteonecrosis of the jaw
* 25 (OH) vitamin D levels \< 20 ng/mL. Vitamin D repletion will be permitted and subjects may be rescreened once 25 (OH) vitamin D level ≥ 20 ng/mL.
* Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (\<8.5 or \>10.5 mg/dL).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05775094
Study Brief:
Protocol Section:
NCT05775094