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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00017069
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of stage II or III multiple myeloma
* Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy
* No more than 3 prior cytotoxic regimens
* No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation
* History of disease progression after prior steroid antimyeloma therapy
* No smoldering myeloma
* Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute granulocyte count greater than 1,200/mm\^3\*
* Platelet count greater than 75,000/mm\^3\*
* Hemoglobin greater than 10 g/dL\* NOTE: \*Unless due to multiple myeloma
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels
* No significant underlying cardiac dysfunction
* No conduction defects
* No unstable angina
* No congestive heart failure
* No New York Heart Association class II-IV cardiac disease
* No myocardial infarction within the past 6 months
Other:
* No preexisting grade 2 or greater neurotoxicity/neuropathy
* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* No uncontrolled diabetes mellitus
* No active serious infection uncontrolled by antibiotics
* No history of grand mal seizures (other than infantile febrile seizures)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* See Chemotherapy
* At least 28 days since prior biologic therapy
Chemotherapy:
* See Disease Characteristics
* At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation
* No other concurrent cytotoxic chemotherapy
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* At least 28 days since prior radiotherapy except for focal radiation for symptom control
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00017069
Study Brief:
Protocol Section:
NCT00017069