etoposide
DrugDay 1~Day 2: 75mg/m^2
Other names: VP-16
NCT Number: NCT06520176
This is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). A total of 99 NDMM patients will be enrolled and randomly assigned to receive either the EAP regimen or the GC regimen (cyclophosphamide+ G-CSF) to mobilize hematopoietic stem cells. Subsequently, the mobilization effects and adverse reactions of all patients will be observed and compared.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Dongyang People's Hospital, Dongyang, Zhejiang, China
According to strict inclusion and exclusion criteria, 99 newly diagnosed MM patients will be selected. They will be randomly assigned in a 2:1 ratio to the EAP group or the CG group. During the hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells >5×10^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells >2×10^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Day 1~Day 2: 75mg/m^2
Other names: VP-16
Day 1~Day 2: 200g/m^2, q12h
Other names: Ara-C
Day 6: 6mg
Other names: PEG-rhG-CSF
Day 1~Day 2: 1~2g/m^2
Other names: Cy
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
Other names: Granulocyte Colony Stimulating Factor
Time frame: 1 month
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10^6/kg) after a single collection
Time frame: 1 month
Comparison of the cumulative proportion of patients who achieve the target collection value (CD34+ cells ≥2×10^6/kg) between the EAP and CG regimens; the proportion of patients who achieve the ideal collection value.
Time frame: 1 month
Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens.
Time frame: 1 month
Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
Time frame: 1 month
Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.
Contact information is provided by the study sponsor or research team.
Peipei Ye
CONTACT
Ying Lu
CONTACT
The Affiliated People's Hospital of Ningbo University
Other Gov
A Prospective, Multicenter, Randomized Controlled Study of Etoposide, Cytarabine Combined With Pegfilgrastim vs. Cyclophosphamide Combined With G-CSF for Hematopoietic Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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