High-dose Chemotherapy+G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma

NCT05517213 | Completed

• 1 other identifier: 307-947168-89
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a multi-center, randomized, prospective study. The purpose is to clarify that high-dose VP-16+G-CSF has better mobilization efficiency and less toxic and side effects compared with high-dose CTX+G-CSF, and minimize mobilization failure, so as to provide convenient and high-quality mobilization programs for clinical practice and enable more patients to enter the transplantation stage smoothly.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Main purpose

  Compared with the literature data, The primary efficacy endpoint was the difference in the proportion of patients who reached the target CD34+ cells ≥5×106/kg and CD34+ cells ≥5×106/kg within 3 days of monotherapy between the study group and the control group.

  Enrollment is expected to last for one year, followed up for two years.

Study Arms (2)

Etoposide

EXPERIMENTAL

Etoposide1.2g/m2(Pump continuously for 24h)+G-CSF10ug/kg.

Drug: Etoposide

Cyclophosphamide

EXPERIMENTAL

Cyclophosphamide 3.0g/m2+Grh-CSF10ug/kg.

Drug: Cyclophosphamide

Interventions

Etoposide DRUG

Chemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.

Also known as: VP-16

Etoposide

Cyclophosphamide DRUG

Chemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.

Also known as: CTX

Cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed MM patients: patients who were initially diagnosed and treated, who were suitable for autologous transplantation and planned to be treated with ASCT;
• Age limitation: 18-70 years old patients; ④ Physical status: ECOG physical status score was 0 or 1; ⑤ The adverse reactions caused by chemotherapy had recovered: peripheral blood leukocytes ≥3.0×109/L, hemoglobin ≥80g/L, platelet ≥80×109/L; Liver function glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase ≤ 2 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value, serum creatinine ≤ 1.5 times the upper limit of normal value, chest CT normal, ecg normal; (5) Patients participate voluntarily and informed consent is signed by patients themselves (or their legal representatives); Take effective contraceptive measures during the childbearing age.

You may not qualify if:

• ① According to the clinical judgment of the researcher: According to NCI CTCAE (4th edition May 28, 2009), patients with ≥3 grade cardiopulmonary insufficiency and severe kidney disease, currently diagnosed as coronary heart disease, myocardial infarction, arrhythmia, glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase ≥ 2 times the upper limit of normal value, Total bilirubin ≥ 1.5 times the upper limit of normal;
• With active infection, including fever of unknown cause (axillary temperature \> 37.5℃); ③ Patients with severe history of mental system.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Hospital 307

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Etoposide; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients were randomly assigned 1:1 to CTX 3.0g/m2+ G-CSF 10ug/kg or VP-16 1.2g/m2+G-CSF10ug/kg

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)