Multiple Myeloma Clinical Trials

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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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Patients newly diagnosed as multiple myeloma.

• 2\. Indication for ASCT.

• 3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0\

• 4\. Life expectancy ≥ 3 months.

• 5\. Subjects must be able to understand the protocol and sign the informed consent.

Locations
Other Locations
China
Dongyang People's Hospital
RECRUITING
Dongyang
The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Tongde Hospital of Zhejiang Province
RECRUITING
Hangzhou
Huzhou central hospital
RECRUITING
Huzhou
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Jinhua Municipal Central Hospital
RECRUITING
Jinhua
Jinhua People's Hospital
RECRUITING
Jinhua
Lishui Central Hospital
RECRUITING
Lishui
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The Affiliated People's Hospital of Ningbo University
RECRUITING
Ningbo
Shaoxing People's Hospital
RECRUITING
Shaoxing
Shaoxing Second Hospital
RECRUITING
Shaoxing
Taizhou Central Hospital
RECRUITING
Taizhou
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Second Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Ying Lu
814871416@qq.com
+86-13486090834
Backup
Peipei Ye
39612903@qq.com
+86-13685832706
Time Frame
Start Date: 2024-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 99
Treatments
Experimental: EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
Active_comparator: CG regimen group
33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
Related Therapeutic Areas
Sponsors
Collaborators: Shaoxing Second Hospital, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Shaoxing People's Hospital, Jinhua Municipal Central Hospital, Second Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital, Taizhou Hospital, First Affiliated Hospital of Zhejiang University, Jinhua People's Hospital, Zhejiang Provincial Tongde Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Affiliated Hospital of Jiaxing University, The Central Hospital of Lishui City
Leads: The Affiliated People's Hospital of Ningbo University

This content was sourced from clinicaltrials.gov