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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT00437034
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed multiple myeloma
* Stage II or III disease according to Salmon-Durie staging criteria
* Relapsed or refractory disease
* Progressive disease
* Measurable disease, defined by ≥ 1 of the following criteria:
* Serum M protein ≥ 1.0 g/dL by serum protein electrophoresis
* Free light chain measurement \> 200 mg/dL
* Urinary M protein excretion ≥ 200 mg/24 hours
* Must have received ≥ 2 prior therapies\* for multiple myeloma that meet the following criteria:
* Antimyeloma therapeutic regimen consisting of ≥ 1 complete course of single-agent or combination-agent therapy, or a planned series of treatments (e.g., 3-4 courses of induction therapy followed by a stem cell harvest procedure followed by conditioning high-dose therapy supported by stem cell transplantation)
* Antimyeloma regimen is discontinued because of the development of resistant disease or severe therapy-related toxicity
* Individual antimyeloma regimen will be considered to have been discontinued when all agents of the regimen have been permanently stopped
* A prior regimen will not be considered to have been discontinued for the modification of drug doses, or if less than all the agents of a combination regimen have been discontinued, or if the regimen has been halted temporarily for the development of a plateau phase of myeloma
* Maintenance therapy will not be considered an additional regimen
* If new agents are added to an existing regimen, presumably because of tumor resistance, the old regimen will be considered to have ended and a new regimen to have started
* No evidence of central nervous system (CNS) disease, including primary brain tumor or brain metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* White blood cell (WBC) ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
* No albuminuria only
* Urine protein: creatinine ratio \< 1 OR 24-hour urine protein with an albumin level \< 500 mg
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
Exclusion criteria:
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No known history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
* No serious or nonhealing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 28 days
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No clinically significant cardiovascular disease
* No prothrombin time (PT) or international normalized ratio (INR) \> 1.5 (unless patient is on full-dose warfarin)
* No evidence of bleeding diathesis or coagulopathy
* No uncontrolled intercurrent illness that would limit compliance with study requirements, including ongoing or active infection
* No psychiatric illness or social situations that would limit study compliance
* No concurrent major surgery
* No concurrent immunosuppressive agents (including steroids)
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00437034
Study Brief:
Protocol Section:
NCT00437034