Comparing two regimens for mobilizing stem cells in multiple myeloma patients

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 prospective, randomized, multicenter study evaluates the efficacy and safety of a combination regimen of etoposide, cytarabine, and Pegfilgrastim (EAP) against a control regimen of cyclophosphamide and G-CSF (CG) for mobilizing hematopoietic stem cells in newly diagnosed multiple myeloma patients. A total of 99 patients will be enrolled and randomly assigned to either the EAP or CG group. The study will compare the effectiveness of stem cell collection and monitor adverse reactions associated with both regimens. Key outcomes include the proportion of patients achieving target stem cell collection values and the cumulative collection of CD34 cells.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Patients newly diagnosed as multiple myeloma.
* 2\. Indication for ASCT.
* 3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
* 4\. Life expectancy ≥ 3 months.
* 5\. Subjects must be able to understand the protocol and sign the informed consent.

Exclusion Criteria:

* 1\. Cardiac function class II or higher or cardiac ejection fraction \<40%.
* 2\. Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN).
* 3\. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN.
* 4\. Serum creatinine clearance rate≤30%.
* 5\. Patients with active infection.
* 6\. Previously received hematopoietic stem cell mobilization.

Where it's running

• Dongyang People's Hospital
  Dongyang, Zhejiang, China Recruiting
• The First Affiliated Hospital, College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• Tongde Hospital of Zhejiang Province
  Hangzhou, Zhejiang, China Recruiting
• Huzhou central hospital
  Huzhou, Zhejiang, China Recruiting
• The First Hospital of Jiaxing
  Jiaxing, Zhejiang, China Recruiting
• Jinhua Municipal Central Hospital
  Jinhua, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ying Lu — The Affiliated People's Hospital of Ningbo University
• Study coordinator: Ying Lu
• Email: 814871416@qq.com
• Phone: +86-13486090834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Induction treatment for newly diagnosed multiple myeloma patients with renal failure

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• Comparing T Cell Depletion Methods for Blood Cancer Treatment

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• Combination treatment for multiple myeloma patients with kidney issues

  This study is testing a new combination treatment for people with multiple myeloma and kidney problems to see if it helps them respond better to therapy before a stem cell transplant.

  Recruiting Phase 2 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT04240054

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.