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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT01660750
Eligibility Criteria:
Inclusion Criteria:
* Cytopathologically or histologically confirmed diagnosis of MM
* Measurable disease, as indicated by one or more of the following:
* Serum M-protein ≥ 1.0 g/dL
* Urine Bence Jones protein ≥ 200 mg/24 hr
* Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria
* Males and females ≥ 18 years of age
* Life expectancy of more than 5 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Adequate hepatic function, with bilirubin \< 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.5 times ULN
* Serum Creatinine Clearance(CrCl) ≥ 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)
* Additional Laboratory Requirements
* Absolute neutrophil count (ANC) ≥1.0 x 109/L
* Hemoglobin ≥8 g/dL \[transfusion permitted\]
* Platelet count ≥50.0 x 109/L
* Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
* Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
* Written informed consent in accordance with federal, local, and institutional guidelines
* Patients must agree to practice contraception
* Male patients must agree not to donate semen or sperm.
Exclusion Criteria:
* Patients with non-secretory or hyposecretory MM
* Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ≤ 1/3 of the pelvic area is also allowed)
* Plasma cell leukemia
* Pregnant or lactating females
* Major surgery within 21 days prior to first dose
* Congestive heart failure (CHF) (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
* Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose
* Patients receiving active treatment or intervention for any other malignancy or patients who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
* Serious psychiatric or medical conditions that could interfere with treatment
* Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
* Contraindication to any of the required concomitant drugs, including antiviral (e.g. Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy in a dose equivalent to dexamethasone ≥ 1.5 mg/day or prednisone ≥ 10 mg/day. (Steroid use is allowed if necessary to treat spinal cord compression and/or hypocalcaemia.)
* Patients in whom the required program of oral and IV fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
* Patients with primary systemic amyloidosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01660750
Study Brief:
Protocol Section:
NCT01660750