Overview

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.