Overview

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

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag International NV
Treatments:
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
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.