Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Multiple Myeloma, Lymphoma|
Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to the protocol, high-dose cyclophosphamide (50mg/kg or 2g/m2, for 2 days) is given to patients with MM, and high-dose etoposide (1.5-1.8g/m2, single dose ) is administered to patients with lymphoma. Apheresis is performed according to the standard institutional regulations. The primary point is to evaluate the percentage of successful mobilization, defined as the cumulative collection of ≥2×10^6/kg CD34+ cells in three or fewer apheresis.
Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
Drug: - Etoposide
Etoposide 1.5-1.8g/m2, single dose
Drug: - Cyclophosphamide
Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
Drug: - Mecapegfilgrastim, day 2
Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Drug: - Mecapegfilgrastim, day 5
Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.