Chemotherapy and G-CSF for Mobilization

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to demonstrate that the mobilization with cytokine stimulation with G-CSF alone is non-inferior as compared to the standard mobilization with chemotherapy and G-CSF while associated with fewer side effects in myeloma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Gemcitabine; Lenograstim; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Myeloma or amyloidosis patients after standard first-line induction treatment. (Additional induction regimens in refractory myeloma patients are allowed)

• Patients must be considered being clinically fit for subsequent consolidation with high-dose melphalan-based chemotherapy with autologous stem cell support.

• Patients must be aged ≥18 years.

• Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to study treatment mobilisation, and they must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months.

• Patients must have given voluntary written informed consent

Exclusion Criteria:

• Patients with concurrent other malignant disease can be included, but previous treatment for other malignancies must have been terminated at least 2 months before registration. Endocrine treatment (such as for breast cancer) is allowed.

• Pregnancy or lactating female patients.

• The use of any anti-cancer investigational agents within 14 days prior to the expected start of trial treatment.