Status:
COMPLETED
Chemotherapy and G-CSF for Mobilization
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wi...
Detailed Description
Background and Rationale High-dose chemotherapy (HDCT) with melphalan and autologous stem cell transplantation (ASCT) remains an integral component of the myeloma treatment algorithm for patients cons...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03442673
Start Date
September 17 2018
End Date
May 1 2024
Last Update
March 28 2025
Active Locations (1)
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1
Department for Medical Oncology University Hospital/Inselspital
Bern, Switzerland, 3010