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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT00054158
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed stage I, II, or III multiple myeloma (MM)
* No refractory or relapsed MM
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin less than 1.5 mg/dL
* AST less than 2.5 times upper limit of normal
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
* No active serious infections uncontrolled by antibiotics
* No insufficient mental capacity that would preclude informed consent
* No other medical condition or reason that would preclude study participation
* Willing and able to comply with the FDA-mandated S.T.E.P.S program
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior thalidomide
Chemotherapy
* No more than 1 course of prior vincristine, doxorubicin, and dexamethasone
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No concurrent alcohol consumption
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00054158
Study Brief:
Protocol Section:
NCT00054158