Status:
COMPLETED
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple myeloma patients.
Detailed Description
Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of eligible patients suffering from multiple myeloma (MM). Tandem autoHSCT allows to further improve results of th...
Eligibility Criteria
Inclusion
- Multiple myeloma patients considered eligible for tandem autologous stm cell transplantation procedure.
- Must have received at least one line of therapy including six or more cycles containing components like thalidomide, bortezomib, lenalidomide or melphalan.
- Must have achieved a partial remission (PR) or better response as assessed by International Myeloma Working Group guidelines.
- Must be 18-65 years of age.
- Must have World Health Organization performance status 0-1.
- Time form discontinuation of administration of any chemotherapy agent must be at least four weeks and immunomodulatory drug at least seven days.
- Hemoglobin level \> 8 g/dl, Absolute neutrophil count (ANC) \> 1.5 x 109/L, Platelet count \>100 x 109/L.
- Serum creatinine \< 1.5 x upper limit of normal (ULN), serum bilirubin \< 1.5 ULN, serum aspartate transaminase (AST/SGOT) \< 2.5 x ULN, serum alanine transaminase (ALT/SGPT) \< 2.5 x ULN.
- Negative human immunodeficiency virus (HIV) infection test.
- Negative pregnancy test.
- Must understand and voluntarily sign informed consent form.
Exclusion
- Failure of prior, first-line mobilization regimen.
- Bone marrow plasma cell infiltration of above 20%.
- Administration of growth-factor other than G-CSF within 4 weeks before starting study treatment.
- Administration of G-CSF within 14 days before starting study treatment.
- Ongoing or active infection.
- Coexisting neoplasm, other than multiple myeloma.
- Pregnant or lactating females.
- Patients treated with use of autologous or allogenic stem cell transplantation in the past.
- Positive human immunodeficiency virus (HIV) infection test.
Key Trial Info
Start Date :
March 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01908621
Start Date
March 20 2013
End Date
October 27 2017
Last Update
August 28 2018
Active Locations (1)
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1
Department of Bone Marrow Transplantation and Oncohematology, Maria Sklodowska-Curie Institute, Oncology Center, Gliwice Branch
Gliwice, Poland, 44-101