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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT00434161
Eligibility Criteria:
Inclusion Criteria:
* Multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan in a one day schedule followed by autologous peripheral blood progenitor cell (PBSCT)
* Body Mass Index (BMI) ≤ 35
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, or an ECOG status of 3 if the reason for a status of 3 is exclusively due to MM (e.g. pathological fracture)
* Functional hematopoietic, hepato-renal and pulmonary systems
* Subjects at minimum with a baseline best corrected visual acuity (BCVA) of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS chart in one eye
* Subject at minimum with one eye with a natural, intact lens
* Subject who has a LOCS III score at baseline of P \< 1.0, C \< 2.0 and NO \< 2.0 in at least one eye
* Women in child bearing potential must have a negative pregnancy test
Exclusion Criteria:
* Presence or history of any other malignancy (other than curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy, without evidence of disease for \> 3 years
* Prior autologous or allogeneic transplants
* Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors
* Receiving dialysis
* History of cataract surgery in both eyes
* Incapable of being responsive to mydriatic agents
* History of other ocular disease (e.g., macular degeneration, glaucoma, corneal disease) that would make assessment of visual status difficult
* Subject is scheduled to undergo cataract surgery
* Subject with any disease, that in the opinion of the ophthalmologist, could adversely effect the subject's vision during the course of the study
* Currently active oral mucositis infection
* Positive for HIV, hepatitis B or C
* Subject is unable or unwilling to follow with study procedures
* Subject is pregnant or is breast feeding
* Subject has not agreed to use adequate contraceptive precautions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00434161
Study Brief:
Protocol Section:
NCT00434161