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

November 21, 2013 updated by: Austrian Forum Against Cancer

Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University Hospital Graz
      • Linz, Austria, 4010
        • Hospital Elisabethinen Linz
      • Salzburg, Austria, 5020
        • LKH Salzburg, 3rd Med. Dept.
      • Vienna, Austria, 1090
        • Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology)
      • Vienna, Austria, 1140
        • Hanusch Hospital Vienna
      • Vienna, Austria, 1160
        • Wilhelminenspital Vienna
      • Wels, Austria, 4600
        • Clinic Wels-Grieskirchen, 4th Internal Dept.
  • Czech Republic
      • Brno, Czech Republic, 63900
        • Faculty hospital Brno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy
Time Frame: 8 cycles à 28 days plus follow-up phase
evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)
8 cycles à 28 days plus follow-up phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 cycles à 28 days plus follow-up phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Forum Against Cancer

Investigators

  • Principal Investigator: Heinz P. Ludwig, Univ. Prof., Wilhelminenspital Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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