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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02085694
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years
* Karnofsky Performance Score ≥ 70%.
* Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
* Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
* Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
* Serum creatinine \< 1.8mg/dl
* Total bilirubin \< 2mg/dl
* Liver enzymes within three times of normal limit
* Expected survival \> 6 months.
Exclusion Criteria:
* Pregnant women and lactating mothers
* Patients with history of HIV infection
* Patients who have taken any other investigational product in last 4 weeks
* Patients having untreated symptomatic dental infection
* Patients with WHO Grade 3 or 4 oral Mucositis
* Other serious concurrent illness
* Inconclusive hematological diagnosis
* Patients with signs and symptoms of systemic infections
* Patient's/guardian's refusal to sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02085694
Study Brief:
Protocol Section:
NCT02085694