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

A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma

This study is testing if giving mecapegfilgrastim after chemotherapy can help patients with multiple myeloma or lymphoma collect enough stem cells from their blood for a transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, radiation, fludarabine, cyclophosphamide
• Locations: 7 sites (Hefei, Anhui and 6 other locations)
• Trial ID: NCT05294055 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 to 65 with multiple myeloma or lymphoma who have had limited prior therapy and are eligible for autologous stem cell transplantation.

Not a fit: Patients who have previously attempted stem cell mobilization or undergone bone marrow transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the efficiency of stem cell mobilization, enhancing treatment options for patients with multiple myeloma and lymphoma.

How similar studies have performed: Other studies have shown promise in using similar approaches for stem cell mobilization, but this specific combination is being evaluated for the first time.

Eligibility 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.

Where this trial is running

Hefei, Anhui and 6 other locations

• 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)
• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Wei Liu

Conditions Multiple Myeloma; Lymphoma; peripheral blood stem cell mobilization; Mecapegfilgrastim; chemotherapy