Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Cyclophosphamide; Bortezomib; Dexamethasone; Lenalidomide
Intervention description: 500 mg, p.o daily, days 1, 8 and 15 for cycles 5 to 8 cycles; 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 for cycles 1 to 8; 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycles 1 to 8; 10 mg orally daily, days 1-14 for cycles 5 to 8
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Lenalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; bortezomib; hematology; bone marrow cancer; immunoglobulin; refractory; progression; dexamethasone; lenalidomide; cyclophosphamide

Summary:

      The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide
      or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that
      have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma
      is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the
      cell, affecting numerous biologic pathways, including those related to growth and survival of
      cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has relapsed/progressed or is refractory for multiple myeloma following 1
             previous line of therapy

          -  Measurable secretory multiple myeloma: measurable disease for secretory multiple
             myeloma is defined by at least one of the following measurements: serum monoclonal
             protein greater than or equal to 1 g/dl (> 10 gm/l) [10g/l], urine M-protein of ≥200
             mg/24 hours

          -  Patient has a Karnofsky performance status of ≥ 60

          -  Patient has a life expectancy estimated at screening of at least 6 months

          -  Patient fulfills defined pretreatment laboratory requirements at and within 14 days
             before baseline

        Exclusion Criteria:

          -  Patient received more than 1 previous line of therapy for multiple myeloma

          -  Patient has known allergy or hypersensitivity to bortezomib, Dexamethasone and/or
             Cyclophosphamide and/or Lenalidomide or any of the constituent compounds such as
             boron, mannitol, or lactose

          -  Patient has oligosecretory or non-secretory multiple myeloma

          -  Patient received nitrosoureas or any other chemotherapy (including thalidomide),
             clarithromycin, interferon within 6 weeks before enrolment. Note: subjects can have
             received thalidomide or interferon as maintenance therapy, according to local standard
             of care

          -  Patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 3 weeks
             before enrolment. Note: subjects can have received steroids (dexamethasone or
             equivalent) as maintenance therapy according to local standard of care. In addition,
             subjects can have received a cumulative dose of up to 160 mg of dexamethasone or
             equivalent as emergency therapy within 3 weeks prior to study entry.