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Trial record 52 of 314 for:    BENDAMUSTINE

Bendamustine Plus Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma (BBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168804
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):
Austrian Forum Against Cancer

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: bendamustine plus bortezomib plus dexamethasone Phase 2

Detailed Description:

After relapse after or early progression on first-line treatment the prognosis of multiple myeloma patients is unfavourable, with no remaining chance for cure. Therefore the search for new treatment regimens, including drugs with novel, and different, mechanisms of action is mandatory.

Both bendamustine and bortezomib are not yet established parts of standard first-line regimens, but showed to have high activity both in chemo-naïve and pre-treated patients. The novel mechanism of action of the proteasome inhibitor and the non-cross resistance of bendamustine to other alkylating agents established in the first-line treatment of multiple myeloma seem to recommend a combination of the two drugs for salvage therapy. The promising response data in a series of relapsing MM patients treated with bendamustine, bortezomib and prednisone support this assumption, as well as the feasibility and tolerability of the combination.

In summary, there is some evidence for a favourable risk/benefit ratio for the combination of bendamustine, bortezomib and a glucocorticoid drug, warranting the exploration in a larger, prospectively designed multicenter phase II study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma
Study Start Date : June 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: single arm bendamustine bortezomib dexamethasone
single arm combination regimen: bendamustine - bortezomib- dexamethasone
Drug: bendamustine plus bortezomib plus dexamethasone
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

Primary Outcome Measures :
  1. efficacy [ Time Frame: 8 cycles à 28 days plus follow-up phase ]
    evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)

Secondary Outcome Measures :
  1. efficacy and safety [ Time Frame: 8 cycles à 28 days plus follow-up phase ]
    assessment of progression-free survival, overall survival, time to maximum response and toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01168804

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Medical University Hospital Graz
Graz, Austria, 8036
Hospital Elisabethinen Linz
Linz, Austria, 4010
LKH Salzburg, 3rd Med. Dept.
Salzburg, Austria, 5020
Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology)
Vienna, Austria, 1090
Hanusch Hospital Vienna
Vienna, Austria, 1140
Wilhelminenspital Vienna
Vienna, Austria, 1160
Clinic Wels-Grieskirchen, 4th Internal Dept.
Wels, Austria, 4600
Czech Republic
Faculty Hospital Brno
Brno, Czech Republic, 63900
Sponsors and Collaborators
Austrian Forum Against Cancer
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Principal Investigator: Heinz P. Ludwig, Univ. Prof. Wilhelminenspital Vienna

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Responsible Party: Austrian Forum Against Cancer Identifier: NCT01168804     History of Changes
Other Study ID Numbers: BBD
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Austrian Forum Against Cancer:
multiple myeloma
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents