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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
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

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dongyang People's Hospital
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DongyangChinaRecruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
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HangzhouChinaRecruiting
Tongde Hospital of Zhejiang Province
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HangzhouChinaRecruiting
Huzhou Central Hospital
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HuzhouChinaRecruiting
The First Hospital Of Jiaxing
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JiaxingChinaRecruiting
Jinhua Municipal Central Hospital
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JinhuaChinaRecruiting
Jinhua People's Hospital
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JinhuaChinaRecruiting
Lishui Central Hospital
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LishuiChinaRecruiting
The Affiliated People's Hospital of Ningbo University
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NingboChinaRecruiting
Ningbo Medical Center Lihuili Hospital
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NingboChinaRecruiting
Shaoxing Second Hospital
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ShaoxingChinaRecruiting
Shaoxing People's Hospital
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ShaoxingChinaRecruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaRecruiting
Taizhou Central Hospital
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TaizhouChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
The Second Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.