Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.

• Status: Completed
• Trial end date: 2017-10-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie Institute - Oncology Center; Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Treatments: Cytarabine; Lenograstim

Criteria

Inclusion Criteria:

1. Multiple myeloma patients considered eligible for tandem autologous stm cell transplantation procedure.

2. Must have received at least one line of therapy including six or more cycles containing components like thalidomide, bortezomib, lenalidomide or melphalan.

3. Must have achieved a partial remission (PR) or better response as assessed by International Myeloma Working Group guidelines.

4. Must be 18-65 years of age.

5. Must have World Health Organization performance status 0-1.

6. Time form discontinuation of administration of any chemotherapy agent must be at least four weeks and immunomodulatory drug at least seven days.

7. Hemoglobin level > 8 g/dl, Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count >100 x 109/L.

8. 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.

9. Negative human immunodeficiency virus (HIV) infection test.

10. Negative pregnancy test.

11. Must understand and voluntarily sign informed consent form.

Exclusion Criteria:

1. Failure of prior, first-line mobilization regimen.

2. Bone marrow plasma cell infiltration of above 20%.

3. Administration of growth-factor other than G-CSF within 4 weeks before starting study treatment.

4. Administration of G-CSF within 14 days before starting study treatment.

5. Ongoing or active infection.

6. Coexisting neoplasm, other than multiple myeloma.

7. Pregnant or lactating females.

8. Patients treated with use of autologous or allogenic stem cell transplantation in the past.

9. Positive human immunodeficiency virus (HIV) infection test.