Comparing two drug regimens to collect stem cells in newly diagnosed myeloma
Compares two drug combinations for collecting stem cells in adults with newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry title: Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
Key facts
- Where
- Dongyang, Hangzhou, Huzhou, Jiaxing, Jinhua, Lishui, Ningbo, Shaoxing, Taizhou, and Wenzhou, ChinaSee the 16 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06520176, who can take part
Where in China
- Dongyang People's HospitalDongyang, ChinaTaking people
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
- Tongde Hospital of Zhejiang ProvinceHangzhou, ChinaTaking people
- Huzhou Central HospitalHuzhou, ChinaTaking people
- The First Hospital Of JiaxingJiaxing, ChinaTaking people
- Jinhua Municipal Central HospitalJinhua, ChinaTaking people
- Jinhua People's HospitalJinhua, ChinaTaking people
- Lishui Central HospitalLishui, ChinaTaking people
- Ningbo Medical Center Lihuili HospitalNingbo, ChinaTaking people
- The Affiliated People's Hospital of Ningbo UniversityNingbo, ChinaTaking people
- Shaoxing People's HospitalShaoxing, ChinaTaking people
- Shaoxing Second HospitalShaoxing, ChinaTaking people
- Taizhou Central HospitalTaizhou, ChinaTaking people
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated People's Hospital of Ningbo University
- Trial code
- NCT06520176
- Record updated
- 25 July 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 6. Previously received hematopoietic stem cell mobilization; 5. Patients with active infection; 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%.