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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01146834
Eligibility Criteria:
Inclusion Criteria:
* Voluntary written informed consent
* Confirmed diagnosis of multiple myeloma
* Age \> than 18 years at the time of signing the informed consent form.
* Karnofsky performance status above 60%
* Patients must be within 30 days of completing induction therapy.
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
* Male subject agrees to use an acceptable method for contraception for the duration of the study.
* Life expectancy \> 12 weeks.
* Subjects must have a MUGA scan or echo with LVEF \>50%
* Subjects must meet the following laboratory parameters:
1. Absolute neutrophil count (ANC) ≥1500 cells/mm3
2. Platelets count ≥ 50,000/mm3
3. Hemoglobin \> 9.0 g/dL
4. Serum SGOT/AST \<3.0 x upper limits of normal (ULN)
5. Serum SGPT/ALT \<3.0 x upper limits of normal (ULN)
6. Serum creatinine \< 2.5 mg/dL or creatinine clearance \> 40ml/min
7. Serum total bilirubin \< 1.5 x ULN
Exclusion Criteria:
* Patients with (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
* History of allergic reactions to compounds containing boron, mannitol, VELCADE
* Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for \> = 5 years.
* NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
* Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Known HIV or hepatitis A, B, or C positivity---ONLY IF ACTIVE
* Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
* Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk
* Patient has \> = Grade 2 peripheral neuropathy within 14 days before enrollment.
* Patient has received other investigational drugs with 14 days before enrollment
* Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01146834
Study Brief:
Protocol Section:
NCT01146834