NCT06520176RecruitingPhase 3
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
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
Source: ClinicalTrials.gov · Last updated 25 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 20 Jul 2024
- Start date
- Aug 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Diseases
- Multiple myeloma
- NCT number
- NCT06520176
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 99
- From Aug 2024 to the primary completion date, Dec 2026
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 6\. Previously received hematopoietic stem cell mobilization.
Other illness
- 5\. Patients with active infection.
Lab values
- 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%.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongyang People's Hospital Coordinator of this site? Confirm its status | Dongyang | China | Recruiting |
| The First Affiliated Hospital, College of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Tongde Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Recruiting |
| The First Hospital Of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Recruiting |
| Jinhua Municipal Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Recruiting |
| Jinhua People's Hospital Coordinator of this site? Confirm its status | Jinhua | China | Recruiting |
| Lishui Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
| The Affiliated People's Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Shaoxing Second Hospital Coordinator of this site? Confirm its status | Shaoxing | China | Recruiting |
| Shaoxing People's Hospital Coordinator of this site? Confirm its status | Shaoxing | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Taizhou Central Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.