Multiple MyelomaPhase 2BBDNCT01168804
Bendamustine Plus Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing bendamustine plus bortezomib plus dexamethasone in people with Multiple Myeloma, run by Austrian Forum Against Cancer at 8 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bendamustine plus bortezomib plus dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jun 2010to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Austria7 sites
Medical University Hospital Graz
Graz, 8036
Hospital Elisabethinen Linz
Linz, 4010
LKH Salzburg, 3rd Med. Dept.
Salzburg, 5020
Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology)
Vienna, 1090
Hanusch Hospital Vienna
Vienna, 1140
Wilhelminenspital Vienna
Vienna, 1160
Clinic Wels-Grieskirchen, 4th Internal Dept.
Wels, 4600
About this study
Official title: 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
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- bendamustine plus bortezomib plus dexamethasone
- Keywords
- multiple myeloma, bendamustine, bortezomib, dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustine plus bortezomib plus dexamethasoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| single arm bendamustine bortezomib dexamethasone | Experimental | single arm combination regimen: bendamustine - bortezomib- dexamethasone Receives: Drug: bendamustine plus bortezomib plus dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)
Measured: 8 cycles à 28 days plus follow-up phase
Secondary outcomes (1)
efficacy and safety
assessment of progression-free survival, overall survival, time to maximum response and toxicity
Measured: 8 cycles à 28 days plus follow-up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Forum Against Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heinz P. Ludwig, Univ. Prof., Principal investigator, Wilhelminenspital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168804
- Sponsor's protocol ID
- BBD
- Acronym
- BBD
- Status last verified
- Nov 2013
- First submitted
- 22 Jul 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01168804
- Acronym / sponsor ID
- BBD / BBD
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, bendamustine, bortezomib, dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Austrian Forum Against CancerUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm bendamustine bortezomib dexamethasone | Experimental | Drug: bendamustine plus bortezomib plus dexamethasonesingle arm combination regimen: bendamustine - bortezomib- dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bendamustine plus bortezomib plus dexamethasoneBendamustine 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 | Drug | single arm bendamustine bortezomib dexamethasone |
Primary outcome
efficacy
Time frame: 8 cycles à 28 days plus follow-up phase
evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)
1 secondary outcome
efficacy and safety
Time frame: 8 cycles à 28 days plus follow-up phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinz P. Ludwig, Univ. Prof. principal investigator
Wilhelminenspital Vienna
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bendamustine plus bortezomib plus dexamethasone in people with Multiple Myeloma, run by Austrian Forum Against Cancer at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy (time frame: 8 cycles à 28 days plus follow-up phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.