Hematopoietic Stem Cell Mobilization, Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Etoposide, Cytarabine, PEG-rhG-CSF, Hematopoietic Stem Cell Mobilization
Brief summary
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.
Detailed description
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.
Interventions
DRUGEtoposide
Day 1\ Day 2: 75mg/m\^2
DRUGCytarabine
Day 1\ Day 2: 200g/m\^2, q12h
DRUGPegfilgrastim
Day 6: 6mg
DRUGCyclophosphamide
Day 1\ Day 2: 1～2g/m\^2
DRUGG-CSF
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
Sponsors
First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
The Central Hospital of Lishui City
Jinhua People's Hospital
Shaoxing People's Hospital
Shaoxing Second Hospital
Zhejiang Provincial Tongde Hospital
Taizhou Hospital
Dongyang People's Hospital
Affiliated Hospital of Jiaxing University
Huizhou Municipal Central Hospital
Second Affiliated Hospital of Wenzhou Medical University
Ningbo Medical Center Lihuili Hospital
Jinhua Municipal Central Hospital
The Affiliated People's Hospital of Ningbo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, two-arm, multicenter, exploratory study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients newly diagnosed as multiple myeloma. * 2\. Indication for ASCT. * 3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0\ 1. * 4\. Life expectancy ≥ 3 months. * 5\. Subjects must be able to understand the protocol and sign the informed consent.
Exclusion criteria
* 1\. Cardiac function class II or higher or cardiac ejection fraction \<40%. * 2\. Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN). * 3\. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN. * 4\. Serum creatinine clearance rate≤30%. * 5\. Patients with active infection. * 6\. Previously received hematopoietic stem cell mobilization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg | 1 month | Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % of patients who use Plerixafor | 1 month | Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens. |
| % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg | 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. |
| CD34+ cells and the average number of collections | 1 month | Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens. |
| Adverse Rvents (AEs) | 1 month | Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens. |
Countries
China
Contacts
Primary ContactYing Lu
Backup ContactPeipei Ye
Outcome results
None listed