Multiple MyelomaPhase 2NCT01526694
Phase II Trial Designed to Determine Efficacy and Safety of Bendamustine+Dexamethasone+Thalidomide in R/R MM
A Phase 2 study testing Bendamustine, Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Azienda Ospedaliera di Bolzano at 19 sites in Italy.
Trial summary
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs. 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, Thalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 19 sitesItaly
- Study dates
- Jul 2012to 8 Apr 2017
- 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
- Understand and voluntarily sign an informed consent form.
- Age 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
- Relapsed or refractory active MM (according to the International Myeloma Working Group guidelines) after treatments containing bortezomib and lenalidomide or ineligible (intolerance or toxicity) to one of these drugs with detectable myeloma protein in blood or urine.
- Disease free of prior malignancies for at least 5 years.
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- All previous multiple myeloma treatments, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, except corticosteroids therapy.
- ECOG performance status <2 at study entry, unless it is due to MM.
- At least the following laboratory findings at the day of treatment start:
- Platelet count ≥ 75 x 10^9/L without transfusional support within 7 days.
- Neutrophil count > 1.5 x 10^9/L without G-CSF.
- Corrected calcium ≤ 14 mg/dL (3.5 mmol/L).
- AST: ≤ 2.5 times the normal upper limit.
- ALT: ≤ 2.5 times the normal upper limit.
- Total bilirubin: ≤ 1.5 times the normal upper limit.
- Measured or calculated creatinine clearance of ≥ 20 mL/minute
- Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use two effective methods of contraception both before and during protocol treatment, or commit to absolute and continuous abstinence.The pregnancy test must be negative 14-28 days and 72 hours before treatment start. Only in case of hysterectomy or presence of menopause for at least 24 consecutive months pregnancy tests as well as contraception are not necessary. Men must not father a child for up to 6 months following cessation of treatment and must use condoms.
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.
- Patients with contraindications for treatment with bendamustine, dexamethasone and thalidomide.
- Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
- Use of any other experimental drug or therapy within 28 days of baseline.
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- Known hypersensitivity to thalidomide or purine analogues
- Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
- Peripheral neuropathy grade ≥2 according to WHO
- Known positive for HIV or infectious hepatitis, type A, B or C.
- Major surgery less than 30 days before start of treatment
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
Ospedale S. Martino
Belluno, 32100
Division of Hematology and CBMT
Bolzano, BZ, 39100
Presidio Ospedaliero di Camposampiero
Camposampiero, Padova, 35012
Ospedale di Castelfranco Veneto
Castelfranco Veneto, 31033
Ospedale Civile di Dolo
Dolo, 30031
AULSS 2 Feltre
Feltre, 32032
Azienda Ospedaliera Universitaria G. Martino
Messina, 98125
Ospedale dell'Angelo di Mestre
Mestre, 30170
A.O di Padova Ematologia e Immunologia Clinica
Padova, 35127
A.O di Padova Ematologia
Padova, 35127
AULLS 18 di Rovigo
Rovigo, 45100
Ospedale di Trento - P.O. S. Chiara
Trento, 38100
Ospedale Ca Foncello
Treviso, 31100
A.O.U Ospedali Riuniti di Trieste Medicina II
Trieste, 34142
A.O.U Ospedali Riuniti di Trieste
Trieste, 34142
A.O.U S. Maria della Misericordia
Udine, 33100
Ospedale Policlinico G.B Rossi (Borgo Roma) Ematologia
Verona, 37134
Ospedale Policlinico G.B Rossi (Borgo Roma) Medicina II
Verona, 37134
AULSS 6 Vicenza
Vicenza, 36100
About this study
Official title: Phase II Multicenter Clinical Trial to Investigate the Efficacy and Safety of Bendamustine, Dexamethasone and Thalidomide in R/R MM Pts After Treatment With Lenalidomide and Bortezomib or Which Are Ineligible to One of These Drugs
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.
Read the detailed description
Eligible patients will be treated according to the following scheme until the occurrence of maximum response, dose limiting toxicity or disease progression. Repeat cycles every 28 days for a maximum of 6 cycles and a minimum of 4.
- Bendamustine 60 mg/m2 i.v. days 1, 8, 15
- Dexamethasone 20 mg p.o. days 1,8 , 15, 22
- Thalidomide 100 mg daily p.o. days 1-28; initial dose of 50 mg/day, with an increment to 100 mg after the first 15 days of treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Bendamustine, Thalidomide, Dexamethasone
- Keywords
- relapsed or refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Ribomustin
Bifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety.
ThalidomideDrug
Thalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment.
DexamethasoneDrug
It's a corticosteroid.
| Study group | Role | What they receive |
|---|---|---|
| treatment with BDT | Experimental | Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) patients after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs. Receives: Drug: Bendamustine; Drug: Thalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The proportion of patient with a Complete Response (CR) or Very Good Partial Response or partial response
Measured: 18 months
Incidence of haematological toxicity of BDT
The incidence of haematological toxicities is the proportion of patients with haematological toxicity
Measured: 18 months
Secondary outcomes (3)
Time to treatment Failure (TTF)
To evaluate time to treatment failure
Measured: 18 months
Survival (OS)
To evaluate overall survival
Measured: 18 months
Disease Free Survival (DFS)
To evaluate disease free survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completion8 Apr 2017
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Bolzano
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Responsible party
- Principal investigator, Michael Mian, Azienda Ospedaliera di Bolzano
- Investigators
- Michael Mian, MD, Principal investigator, Azienda Ospedaliera di Bolzano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526694
- Sponsor's protocol ID
- BDT-01-2011
- Status last verified
- Jul 2018
- First submitted
- 27 Jan 2012
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Clinical Trial to Investigate the Efficacy and Safety of Bendamustine, Dexamethasone and Thalidomide in R/R MM Pts After Treatment With Lenalidomide and Bortezomib or Which Are Ineligible to One of These Drugs
- ClinicalTrials.gov ID
- NCT01526694
- Acronym / sponsor ID
- BDT-01-2011
- Conditions
- Multiple Myeloma
- Keywords
- relapsed or refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di BolzanoUniversity, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 8 Apr 2017 (actual)
- First posted
- 6 Feb 2012 (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.
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.
Detailed description
Eligible patients will be treated according to the following scheme until the occurrence of maximum response, dose limiting toxicity or disease progression. Repeat cycles every 28 days for a maximum of 6 cycles and a minimum of 4.
- Bendamustine 60 mg/m2 i.v. days 1, 8, 15
- Dexamethasone 20 mg p.o. days 1,8 , 15, 22
- Thalidomide 100 mg daily p.o. days 1-28; initial dose of 50 mg/day, with an increment to 100 mg after the first 15 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment with BDT | Experimental | Drug: Bendamustine, Drug: Thalidomide, Drug: DexamethasoneBendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) patients after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Understand and voluntarily sign an informed consent form.
- Age 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
- Relapsed or refractory active MM (according to the International Myeloma Working Group guidelines) after treatments containing bortezomib and lenalidomide or ineligible (intolerance or toxicity) to one of these drugs with detectable myeloma protein in blood or urine.
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.
- Patients with contraindications for treatment with bendamustine, dexamethasone and thalidomide.
- Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
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 |
|---|---|---|
| BendamustineAlso: RibomustinBifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety. | Drug | treatment with BDT |
| ThalidomideThalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment. | Drug | treatment with BDT |
| DexamethasoneIt's a corticosteroid. | Drug | treatment with BDT |
Primary outcome
Response rate
Time frame: 18 months
The proportion of patient with a Complete Response (CR) or Very Good Partial Response or partial response
Incidence of haematological toxicity of BDT
Time frame: 18 months
The incidence of haematological toxicities is the proportion of patients with haematological toxicity
3 secondary outcomes
Time to treatment Failure (TTF)
Time frame: 18 months
Survival (OS)
Time frame: 18 months
Disease Free Survival (DFS)
Time frame: 18 months
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 3 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Michael Mian, MD principal investigator
Azienda Ospedaliera di Bolzano
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine, Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Azienda Ospedaliera di Bolzano at 19 sites in Italy.
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 17 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. 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?
Response rate (time frame: 18 months). The study lists 2 primary outcomes in all. 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 3 Jul 2018.