Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma

Study Purpose

This is a multicenter prospective study to evaluate the efficacy and safety of chemotherapy combined with a single dose of subcutaneous(SC) injection mecapegfilgrastim on day 2 or day 5 after chemotherapy for autologous peripheral blood stem cell (PBSC) mobilization in patients with multiple myeloma or lymphoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy; 2. Patients who had achieved at least partial response (PR); 3. Patients who were eligible for autologous peripheral blood stem cell transplantation. 4. Age≥18 and≤65 years; 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Patients who have an estimated life expectancy of more than three months. 7. Fertile patients must be willing to use reliable contraception during the clinical study period and for 90 days after the last dose and have a negative serological pregnancy test within 72 hours prior to the first dose. 8. Patients must be able and willing to give written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. Patients who had previously attempted hematopoietic stem cell mobilization; 2. Patients who had undergone previous bone marrow transplantation; 3. Lymphoma patients with bone marrow involvement or patients with MM who had >10% bone marrow involvement at screening ; 4. Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval >500ms, left ventricular ejection fraction (EF)<60%, or other heart diseases that the investigator considers unsuitable for hematopoietic stem cell mobilization or hematopoietic stem cell transplantation; 5. Patients with uncontrolled pulmonary infection; 6. Patients who had any of the following laboratory indicators: 1. White blood cell count(WBC)<2.5×109/L; 2. Absolute neutrophil count(ANC)<1.5×109/L; 3. Platelets count(PLT)<80×109/L; 4. Creatinine > 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min. 5. AST/ALT/Total bilirubin > 2.5 X ULN; 7. Patients who have received any of the following treatments: 1. Patients who had been treated with more than 4 cycles of lenalidomide or received lenalidomide within 4 weeks prior to hematopoietic stem cell mobilization chemotherapy. 2. Patients who previously been treated with fludarabine or melphalan; 3. Patients who plan to receive radiation within 30 days after transplantation. 4. Patients who had received radiation therapy in the pelvis. 8. Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli. 9. Patients who are pregnant or breastfeeding. 10. Patients who are participating in other clinical studies or the interval of the last dose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5 half-lives of the study drug); 11. Patients with other conditions unsuitable for this study according to the investigator's judgment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05294055
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Qiu Lugui
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Lymphoma
Additional Details

Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to the protocol, high-dose cyclophosphamide (50mg/kg or 2g/m2, for 2 days) is given to patients with MM, and high-dose etoposide (1.5-1.8g/m2, single dose ) is administered to patients with lymphoma. Apheresis is performed according to the standard institutional regulations. The primary point is to evaluate the percentage of successful mobilization, defined as the cumulative collection of ≥2×10^6/kg CD34+ cells in three or fewer apheresis.

Arms & Interventions

Arms

Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2

Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5

Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2

Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5

Interventions

Drug: - Etoposide

Etoposide 1.5-1.8g/m2, single dose

Drug: - Cyclophosphamide

Cyclophosphamide 50mg/kg or 2g/m2, for 2 days

Drug: - Mecapegfilgrastim, day 2

Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy

Drug: - Mecapegfilgrastim, day 5

Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Anhui Provincial Hospital, Hefei, Anhui, China

Status

Address

Anhui Provincial Hospital

Hefei, Anhui,

Site Contact

Zimin Sun

liuwei@ihcams.ac.cn

86-022-23909282

Peking University Third Hospital, Beijing, Beijing, China

Status

Address

Peking University Third Hospital

Beijing, Beijing,

Site Contact

Hongmei Jing

liuwei@ihcams.ac.cn

86-022-23909282

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Address

Henan Cancer Hospital

Zhengzhou, Henan,

Site Contact

Baijun Fang

liuwei@ihcams.ac.cn

86-022-23909282

Shandong Cancer Hospital, Jinan, Shandong, China

Status

Address

Shandong Cancer Hospital

Jinan, Shandong,

Site Contact

Zengjun Li

liuwei@ihcams.ac.cn

86-022-23909282

Tianjin, Tianjin, China

Status

Address

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin, 300020

Tianjin, Tianjin, China

Status

Address

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin,

Site Contact

Yafei Wang

liuwei@ihcams.ac.cn

86-022-23909282

Tianjin, Tianjin, China

Status

Address

Tianjin Medical University General Hospital

Tianjin, Tianjin,

Site Contact

Rong Fu

liuwei@ihcams.ac.cn

86-022-23909282