Bendamustine Plus Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
BBD
1 other identifier
interventional
79
2 countries
8
Brief Summary
The purpose of this study is to evaluate efficacy and safety of the combination regimen of bortezomib-bendamustine-dexamethasone in patients with relapsed or refractory multiple myeloma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Jun 2010
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 25, 2013
November 1, 2013
2.9 years
July 22, 2010
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy
evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)
8 cycles à 28 days plus follow-up phase
Secondary Outcomes (1)
efficacy and safety
8 cycles à 28 days plus follow-up phase
Study Arms (1)
single arm bendamustine bortezomib dexamethasone
EXPERIMENTALsingle arm combination regimen: bendamustine - bortezomib- dexamethasone
Interventions
Bendamustine 70 mg/m2 on days 1+4 Velcade 1.3 mg/m2 on days 1,4,8,11 Dexamethasone 20 mg on days 1,4,8 and 11 Repeated every 4 weeks
Eligibility Criteria
You may qualify if:
- Age min. 18 years at the time of signing the informed consent form
- Life expectancy of at least 3 months
- 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 measurements: Serum M-protein ≥ 10g/l; Urine light-chain (M-protein) of ≥ 200 mg/24 hours; Serum 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) in need of therapy
- All previous cancer therapy, including cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, except corticosteroid therapy (dosage 40 to max. 160mg). 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 0-2 at study entry
- Laboratory test results within these ranges:
- Absolute neutrophil count min. 1.5 x 109/L
- Platelet count min. 75 x 109/L
- Total bilirubin max. 1.5 mg/dL
- AST (SGOT) and ALT (SGPT) max. 2 x ULN or max. 5 x ULN if hepatic lesions are present.
- Disease free of prior malignancies for min. 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
- No study treatment or any other procedure within the framework of the trial (except for screening) will be performed in any patient prior to receipt of written informed consent.
You may not qualify if:
- 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 pre-study visit.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Medical University Hospital Graz
Graz, 8036, Austria
Hospital Elisabethinen Linz
Linz, 4010, Austria
LKH Salzburg, 3rd Med. Dept.
Salzburg, 5020, Austria
Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology)
Vienna, 1090, Austria
Hanusch Hospital Vienna
Vienna, 1140, Austria
Wilhelminenspital Vienna
Vienna, 1160, Austria
Clinic Wels-Grieskirchen, 4th Internal Dept.
Wels, 4600, Austria
Faculty Hospital Brno
Brno, 63900, Czechia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heinz P. Ludwig, Univ. Prof.
Wilhelminenspital Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 25, 2013
Record last verified: 2013-11