Multicenter Phase II Study:Bendamustine plus Bortezomib plus Dexamethasone in the treatment of stage II/III relapsed or refractory multiple myeloma - BBD

• Conditions: Patients suffering from stage II/III (Salmon & Durie) relapsed or refractory multiple myeloma

• Registration Number: EUCTR2008-006421-13-CZ
• Lead Sponsor: Wilhelminen Krebsforschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-31
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

•Age at least 18 years at the time of signing the informed consent form
•Life expectancy of at least 3 month
•Able to adhere to the study visit schedule and other protocol requirements
•Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements1:
oSerum M-protein = 10g/l
oUrine light-chain (M-protein) of = 200 mg/24 hours
oSerum FLC assay: involved FLC level =10 mg/dl provided sFLC ratio is abnormal

•Relapsed or refractory MM in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria)
•All previous cancer therapy, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroid therapy. Localised radiation therapy is allowed, but the increased risk of leukocytopenia, erythrocytopenia and thrombocytopenia based on the combination of a polychemotherapy and radiation therapy has to be considered and a close monitoring of the patients has to be assured.
•ECOG performance status of minimum 2 at study entry
•Laboratory test results within these ranges:
-Absolute neutrophil count minimum 1.5 x 109/L
-Platelet count minimum 75 x 109/L
-Total bilirubin not more than 1.5 mg/dL
-AST (SGOT) and ALT (SGPT) not more than 2 x ULN or not more than 5 x ULN if hepatic lesions are present.
•Disease free of prior malignancies for minimum of 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
•Fertile patients must use effective contraception during and for 6 months after study treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
•Pregnant or breast feeding females
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by NCI CTCAE, version 3.0.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Known hypersensitivity to the study drugs
•Any prior use of bortezomib or bendamustine in the last six months
•Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan
•Known positive for HIV or infectious hepatitis, type A, B or C
•Active, uncontrolled infections
•Acute diffuse infiltrative pulmonary disease and pericardial disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified