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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00358020
Eligibility Criteria:
Inclusion Criteria:
* Patient is of a legally consenting age as defined by local regulations.
* Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
* Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
* Patient was previously diagnosed with multiple myeloma based on standard criteria.
* Patient is relapsed or refractory after one or two lines of treatment including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide- and melphalan-based regimens.
* Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of \>200 mg/24 hours.
* Patient has a Karnofsky performance status ≥60%.
* Patient has a life-expectancy \>3 months.
* Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration):
* Platelet count ≥75 x 109/L without transfusion support within 7 days before the test.
* Absolute neutrophil count (ANC) ≥ 0.75 x 109/L without the use of growth factors.
* Corrected serum calcium ≤14 mg/dL (3.5 mmol/L).
* Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
* Alanine transaminase (AST): ≤ 2.5 x the ULN.
* Total bilirubin: ≤ 1.5 x the ULN.
* Calculated or measured creatinine clearance: ≥20 mL/minute.
Exclusion Criteria:
* Patient has an absolute neutrophil count \<0.75 × 109/L within 14 days before enrollment.
* Patient has a calculated or measured creatinine clearance \<20 mL/minute within 14 days before enrollment.
* Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
* Patient has known hypersensitivity to bortezomib, boron, mannitol or thalidomide.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00358020
Study Brief:
Protocol Section:
NCT00358020