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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT00153933
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.
* Must have relapsed or relapsed/refractory disease
* 18 years of age or older
* All baseline studies must be performed within 21 days of enrollment.
* ECOG performance status of 0 to 2
Exclusion Criteria:
* Renal insufficiency (serum creatinine levels \> 2mg/dL)
* Concomitant therapy medications that include corticosteroids
* Peripheral neuropathy of Grade 3 or greater or painful Grade 2
* Evidence of mucosal or internal bleeding and/or platelet refractory
* ANC \< 1000 cells/mm3
* Hemoglobin \< 8.0 g/dL
* AST (SGOT and ALT) \> 2 x ULN
* Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
* Known hypersensitivity to thalidomide or the development of erythema nodosum
* Active infection or serious co-morbid medical condition
* Pregnant or breast-feeding women
* Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00153933
Study Brief:
Protocol Section:
NCT00153933