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 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT00800059
Eligibility Criteria:
Inclusion Criteria:
* A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment.
* Subject must have primary refractory or relapsed multiple myeloma.
* Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
* Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
* An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation.
* Subject must be of age more than 18 and less than 60 years.
* Subject must have an ECOG performance score of 0,1, or 2.
* Subject must have the ability to comply with the protocol visit schedule and other protocol requirements.
Exclusion Criteria:
* A subject meeting any of the following criteria is not eligible for participation in the study:
* Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM.
* Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
* Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
* Subjects who have previously received radiation treatments or other neoplastic disorders.
* Subjects with a history of non-compliance in other studies.
* Pregnant or lactating female subjects.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00800059
Study Brief:
Protocol Section:
NCT00800059