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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT01370434
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed symptomatic MM (see Appendix I)
* Patients should be eligible for AHCT.
* Patients should have measurable serum or urine paraprotein.
* The performance status of the patients should be 70 or over by Karnofsky performance scale
* Adequate hepatic and renal function: serum bilirubin \< 1.5 x the upper limit of normal (ULN), serum alanine aminotransferase (ALT)/aspartate aminotransaminase (AST) values \< 2.5 x ULN, serum creatinine \< 1.5 x ULN
* Adequate cardiac function: ejection fraction \> 40% by echocardiogram or radionuclide heart scan
Exclusion Criteria:
* prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or localized radiotherapy or plasmapheresis for the treatment of clinically significant hyperviscosity syndrome
* have a peripheral neuropathy of grade 2 or more within 14 days of enrollment.
* significant infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT01370434
Study Brief:
Protocol Section:
NCT01370434