PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

High-dose chemotherapy with autologous stem cell support is the current standard procedure in the first-line treatment in younger patients with myeloma fit for intensive treatment. Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and autologous stem cell transplant. In this trial the intravenous application of Plerixafor is being investigated in respect of the capability of the mobilization of stem cells from the bone marrow into the peripheral blood. In contrast to the twice daily application of G-CSF (eg. Neupogen) for several days, Plerixafor has to be injected just one-time.

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

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: JM 3100; Lenograstim; Plerixafor; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Symptomatic stage I or stage II and III myeloma patients after standard first-line non-melphalan containing 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 (up to 4 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD regimen.

• Patients must have achieved at least a partial response according to the Bladé criteria after induction chemotherapy.

• Patient must be aged 18-70 years, with an ECOG < 2 and has given voluntary written informed consent.

• 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.

• Corrected serum calcium < 3 mmol/L.

• Aspartate transaminase (AST) <= 1.5 x ULN.

• Alanine transaminase (ALT) <= 1.5 x ULN.

• Total bilirubin <= 2 x ULN.

• Creatinin-clearance >= 50 ml/min.

• Negative pregnancy test within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate measures to avoid pregnancy during study treatment and for additional 12 months. No pregnant or lactating patients are allowed.

Exclusion Criteria

• Patients previously treated with melphalan or extensive radiotherapy to the bone marrow.

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

• Patients not fit for autologous stem cell transplantation.

• Patient receiving colony stimulating factors.

• Patient underwent plasmaphereses within 4 weeks before enrolment.

• Patient had major surgery within 4 weeks before enrolment.

• Patient has 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.

• Sero-positive for HIV antibody.

• Patient known to be hepatitis B surface antigen positive or who has an active hepatitis C infection.

• Patient has an active systemic infection requiring treatment.

• Female patient is pregnant or breast feeding.

• Compromised renal function as evidenced by measured or calculated creatinine clearance <= 50 ml/min.

• Subject is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial or is receiving other investigational agent.