NCT06520176 Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
| NCT ID | NCT06520176 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Affiliated People's Hospital of Ningbo University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 99 participants in total. It began in 2024-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ying Lu
PRINCIPAL INVESTIGATOR
The Affiliated People's Hospital of Ningbo University
Frequently Asked Questions
Who can join the NCT06520176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06520176 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 99 participants.
Is NCT06520176 currently recruiting?
Yes, NCT06520176 is actively recruiting participants. Contact the research team at 814871416@qq.com for enrollment information.
Where is the NCT06520176 trial being conducted?
This trial is being conducted at Dongyang, China, Hangzhou, China, Hangzhou, China, Huzhou, China and 11 additional locations.
Who is sponsoring the NCT06520176 clinical trial?
NCT06520176 is sponsored by The Affiliated People's Hospital of Ningbo University. The principal investigator is Ying Lu at The Affiliated People's Hospital of Ningbo University. The trial plans to enroll 99 participants.