Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated
      high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide,
      also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory
      rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a
      myeloma functionality.

      The objectives of the present study are whether patients with refractory or relapsed multiple
      myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit
      from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects.
      Recently two studies have shown with thalidomide that maintenance therapy might improve EFS
      and one study also the OS.
    


Intervention name(s): Bortezomib; Cyclophosphamide; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.
Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.; Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.
Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.; Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.
Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.
Other intervention name(s): Velcade; Endoxan
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bortezomib; cyclophosphamide; dexamethason; multiple myeloma