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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT01541332
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of MM based on standard criteria (Durie 1986)
* Currently has MM with measurable disease, defined as:
* a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or
* urine monoclonal protein levels of at least 200 mg/24 hours
* for patients without measurable serum and urine M-protein levels, an abnormal free light chain ratio (normal value: 0.26 - 1.65)
* Currently has progressive MM that has relapsed or is refractory, defined as:
* For the phase 1: Relapsed following stabilization or a response to at least one anti-myeloma regimen or refractory defined as progressed while receiving an anti-myeloma treatment
* For the phase 2: Refractory to lenalidomide as demonstrated by progressive disease while on lenalidomide or that relapsed within 8 weeks of the last dose of lenalidomide either as a single agent or in combination.
* Prior treatment with four days or less of a total of 400 mg of prednisone (or an equivalent potency of another steroid) for MM will not be considered a regimen
* Able to adhere to the study visit schedule and other protocol requirements
* ECOG performance status of 2 or greater at study entry
* Life-expectancy of greater than 3 months
* Lab tests within study ranges at study entry:
* Absolute neutrophil count \> 1.5 x 109/L
* Platelet count \> 75 x 109/L
* Hemoglobin \> 8 g/dL
* Calculated or measured creatinine clearance \> 30 mL/minute
* Total bilirubin \< 1.5 x upper limit of normal (ULN)
* AST (SGOT) and ALT (SGPT) \< 2 x ULN
* Serum potassium within the normal range
* Females of childbearing potential must have a negative serum or urine pregnancy test.
* Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to ASA may use warfarin or low molecular weight heparin)
Exclusion Criteria:
* POEMS syndrome
* Plasma cell leukemia
* Primary amyloidosis
* Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
* Impaired cardiac function or clinically significant cardiac diseases
* Severe hypercalcemia
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a subject with a recent history of kyphoplasty with the medical monitor)
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
* Received the following prior therapy:
* Pomalidomide
* Chemotherapy within 3 weeks of study drugs (6 wks for nitrosoureas)
* Corticosteroids (\>10 mg/day prednisone or equivalent) within 3 weeks of study drugs
* Immunotherapy or antibody therapy as well as thalidomide, lenalidomide, arsenic trioxide or bortezomib within 21 days before study drugs
* Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.
* Use of any other experimental drug or therapy within 28 days of study drugs
* Known hypersensitivity to compounds of similar chemical or biological composition to thalidomide, lenalidomide or doxorubicin.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
* Concurrent use of other anti-cancer agents or treatments
* Known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis B or C is not required
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01541332
Study Brief:
Protocol Section:
NCT01541332