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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT00609167
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of symptomatic multiple myeloma
* Durie Salmon stage 2 or higher
* Previously untreated multiple myeloma (including immunomodulatory drugs such as thalidomide) with the exception of bisphosphonates
* Evaluable or measurable disease, as defined by at least one of the following:
* Serum monoclonal protein ≥ 1 g/dL (measurable disease)
* Urine monoclonal protein ≥ 200 mg/24 hours by protein electrophoresis (measurable disease)
* Serum-free light chains (FLC) ≥ 10 mg/dL, kappa or lambda, accompanied by an abnormal kappa/lambda ratio
Serum FLC's should only be used for patients without measurable serum or urine m-spike
\- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
\* Patients diagnosed with smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
\- ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
* Total bilirubin normal OR direct bilirubin ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Creatinine ≤ 3.5 mg/dL
* Absolute neutrophil count ≥ 1,000/mm³ without transfusion or growth factor
* Platelet count ≥ 100,000/mm³ without transfusion or growth factor
* Willingness and the physical and mental capability to provide written informed consent
* Willingness to return to Mayo Clinic Arizona/Princess Margaret Hospital for follow-up
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Exclusion criteria:
* Peripheral sensory neuropathy ≥ grade 2 as defined by National Cancer Institute (NCI) Common Terminology for Common Adverse Events (CTCAE) version 3.0
* Known hypersensitivity to compounds containing boron or mannitol
* Active uncontrolled infection
* Severe cardiac comorbidity including but not limited to:
* New York Heart Association class III or IV heart failure
* History of myocardial infarction within the past 6 months
* Uncontrolled angina or electrocardiographic (ECG) evidence of acute ischemia
* Severe uncontrolled ventricular arrhythmias or ECG evidence of active conduction system abnormalities
* Cardiac amyloidosis with hypotension (i.e., systolic blood pressure \< 100 mm Hg)
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent study compliance or completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior high-dose corticosteroid therapy for 12 days or less is permitted for emergent complications from newly diagnosed multiple myeloma
* More than 14 days since prior investigational agents
* No concurrent steroids or any other anticancer agents or treatments
\- Patients may receive the equivalent of up to 20 mg prednisone per day for concurrent illness or adrenal replacement therapy
* Concurrent palliative radiotherapy for bony pain or fracture is allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00609167
Study Brief:
Protocol Section:
NCT00609167