Using Mecapegfilgrastim with chemotherapy to mobilize stem cells in blood for cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective study evaluates the efficacy and safety of combining chemotherapy with a single dose of mecapegfilgrastim to mobilize peripheral blood stem cells in patients with multiple myeloma or lymphoma. Eligible patients will receive high-dose cyclophosphamide or etoposide followed by a subcutaneous injection of mecapegfilgrastim on either day 2 or day 5 post-chemotherapy. The primary goal is to assess the success rate of stem cell mobilization, defined as collecting a sufficient number of CD34+ cells for transplantation. Apheresis will be conducted according to standard institutional protocols.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Not yet recruiting
• Shandong Cancer Hospital
  Jinan, Shandong, China Not yet recruiting

Study contacts

• Study coordinator: Wei Liu
• Email: liuwei@ihcams.ac.cn
• Phone: 86-022-23909282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.