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New treatment option for Multiple Myeloma
Official title Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma
ClinicalTrials.gov ID: NCT05294055
What this study is testing
What is Etoposide?
Etoposide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
- Patients who had achieved at least partial response (PR);
- Patients who were eligible for autologous peripheral blood stem cell transplantation
- Age≥18 and≤65 years;
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You likely can't join if
- Patients who had previously attempted hematopoietic stem cell mobilization;
- Patients who had undergone previous bone marrow transplantation;
- Lymphoma patients with bone marrow involvement or patients with MM who had \>10% bone marrow involvement at screening ;
- Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation...
- Patients with uncontrolled pulmonary infection;
- Patients who had any of the following laboratory indicators:
See the full eligibility criteria
- Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
- Patients who had achieved at least partial response (PR);
- Patients who were eligible for autologous peripheral blood stem cell transplantation
- Age≥18 and≤65 years;
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients who have an estimated life expectancy of more than three months
- 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.
- Patients must be able and willing to give written informed consent prior to any study-related procedures
- Patients who had previously attempted hematopoietic stem cell mobilization;
- Patients who had undergone previous bone marrow transplantation;
- Lymphoma patients with bone marrow involvement or patients with MM who had \>10% bone marrow involvement at screening ;
- Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency...
- Patients with uncontrolled pulmonary infection;
- Patients who had any of the following laboratory indicators:
- White blood cell count(WBC)\<2.5×109/L；
- Absolute neutrophil count(ANC)\<1.5×109/L；
- Platelets count(PLT)\<80×109/L；
- Creatinine \> 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min
- AST/ALT/Total bilirubin \> 2.5 X ULN；
- Patients who have received any of the following treatments:
- 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.
- Patients who previously been treated with fludarabine or melphalan;
- Patients who plan to receive radiation within 30 days after transplantation
- Patients who had received radiation therapy in the pelvis
- Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli.
- Patients who are pregnant or breastfeeding
- 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);
- Patients with other conditions unsuitable for this study according to the investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Zhengzhou, Henan, China
- Jinan, Shandong, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Zhengzhou, Henan, China; Jinan, Shandong, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.