This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.
Eligible patients will be treated according to the following scheme until the occurrence of maximum response, dose limiting toxicity or disease progression. Repeat cycles every 28 days for a maximum of 6 cycles and a minimum of 4. * Bendamustine 60 mg/m2 i.v. days 1, 8, 15 * Dexamethasone 20 mg p.o. days 1,8 , 15, 22 * Thalidomide 100 mg daily p.o. days 1-28; initial dose of 50 mg/day, with an increment to 100 mg after the first 15 days of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Bifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety.
Thalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment.
It's a corticosteroid.
Division of Hematology and CBMT
Bolzano, BZ, Italy
Presidio Ospedaliero di Camposampiero
Camposampiero, Padova, Italy
Response rate
The proportion of patient with a Complete Response (CR) or Very Good Partial Response or partial response
Time frame: 18 months
Incidence of haematological toxicity of BDT
The incidence of haematological toxicities is the proportion of patients with haematological toxicity
Time frame: 18 months
Time to treatment Failure (TTF)
To evaluate time to treatment failure
Time frame: 18 months
Survival (OS)
To evaluate overall survival
Time frame: 18 months
Disease Free Survival (DFS)
To evaluate disease free survival
Time frame: 18 months
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...and 9 more locations