Vinorelbine and Gemcitabine in Myeloma

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients

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

Details

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

Criteria

Inclusion Criteria:

• Symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.

• Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (less than 5 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD (vincristine, adriamycin and dexamethasone) regimen.

• Patient must be aged 18-75 years, with an ECOG (Eastern Cooperative Oncology Group) < 3, and has given voluntary written informed consent.

• Patient has the following laboratory values at baseline:

• Platelets count > 50 x 109/l without transfusion support within 7 days before the laboratory test.

• Absolute neutrophil count (ANC) > 1.0 x 109/l without the use of colony stimulating factors.

• Creatinine-clearance > 40 ml/min

• Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential 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. No pregnant or lactating patients are allowed.

Exclusion Criteria:

• Patients with more than 4 cycles of chemotherapy with lenalidomide.

• Patients not fit for autologous stem cell transplantation

• Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.

• Subject is currently enrolled in another investigational trial or is receiving other investigational agent(s).