Multiple Myeloma Clinical Trial
— UCBTOfficial title:
A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen
Verified date | August 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
Status | Completed |
Enrollment | 9 |
Est. completion date | August 29, 2016 |
Est. primary completion date | August 29, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients with a diagnosis that qualifies them for UCBT - Adequate organ function - Availability of eligible donor material Exclusion Criteria: - Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used - Human immunodeficiency virus (HIV) infection - Active infection |
Country | Name | City | State |
---|---|---|---|
United States | Novartis Investigative Site | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absence of Graft Failure at Day 42 | This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning. | 42 days | |
Secondary | Incidence of Neutrophil Recovery Within 42 Days | Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L. | 42 days | |
Secondary | Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year | NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration. | 1 year | |
Secondary | Incidence of Overall Survival Within One Year | Overall survival is the proportion of patients who were alive at the end of the one year study period. | 1 year | |
Secondary | Incidence of Relapse-free Survival Within One Year | Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study. | 1 year |
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