Multiple MyelomaPhase 2NCT01056276
Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy
A Phase 2 study testing Bendamustine, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by SCRI Development Innovations, LLC at 13 sites in United States.
Trial summary
In this study, investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities. 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, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2010to Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must meet the Durie and Salmon criteria for initial diagnosis of multiple myeloma.
- Previously histologically confirmed, multiple myeloma with indication for therapy including one of the following:
- Hemoglobin <10 g/dl or 2 g/dl below normal
- Serum calcium >11.5 mg/dl
- Creatinine >2 mg/dl
- Lytic bone lesions or severe osteopenia
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- Extramedullary plasmacytomas
- Patients should not be considered candidates for high dose therapy/autologous stem cell transplantation due to coexistent medical conditions, advanced age, poor performance status, refusal of high dose chemotherapy, or other reasons as judged by the patient and/or physician.
- ECOG Performance Status 0-2.
- WBC ≥3000/mL; ANC ≥1000/mL; platelets ≥50,000/mL (patients with platelets ≥30,000/mL are eligible if thrombocytopenia is felt to be due to extensive bone marrow involvement with myeloma).
- Patients with adequate organ function as measured by:
- Renal: Serum creatinine <2.0 mg/dL or a calculated or measured creatinine clearance of >30 mL/minute.
- Hepatic: Total bilirubin < 1.5 x ULN and ALT and AST <2.5 x the ULN (<5 x ULN for patients with liver involvement).
- Patients must have measurable or evaluable disease. In patients with disease limited to bone and bone marrow, serial paraprotein measurements are acceptable for evaluable disease.
- Patients must be accessible for treatment and follow-up procedures.
- Male or female patients 18 years of age or older.
- Patients must provide written informed consent prior to receiving protocol therapy.
- Women of childbearing potential must agree to use a medically acceptable method of birth control(e.g., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 12 months after their last dose of rituximab. Men must use an acceptable form/method of contraception for the duration of treatment and for 3 months after the end of treatment.
- Patients must be able to understand the nature of this study and give written informed consent.
Who cannot join
- Previous therapy for multiple myeloma with the exception of an initial 4-day course of pulsed dexamethasone.
- Patients with ≥NCI CTCAE v4.0 grade 2 peripheral neuropathy ≤14 days prior to study enrollment.
- Treatment with investigational agent(s) ≤14 days prior to study enrollment.
- Active infection or infection requiring intravenous antibiotic treatment at the time of accrual.
- Known to be HIV positive (HIV test is not required for participation in the trial).
- Patients with class III/IV cardiac problems as defined by the New York Heart Association (NYHA)criteria:
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- History of uncontrolled or symptomatic angina
- History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
- Myocardial infarction < 6 months from study entry
- Uncontrolled or symptomatic congestive heart failure
- Ejection fraction below the institutional normal limit
- Any other cardiac condition that, in the opinion of the treatment physician, would make this protocol unreasonably hazardous for the patient
- Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg)or uncontrolled cardiac arrhythmias.
- Prior to study entry, any ECG abnormality at Screening must be documented by the investigator as not medically relevant.
- Other serious medical conditions or psychiatric illness that would potentially interfere with patient participation in this trial.
- A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix,unless the tumor was treated with curative intent at least 2 years previously or low-risk prostate cancer after curative therapy.
- Known hypersensitivity to bortezomib, boron, or mannitol.
- Female patient is pregnant or lactating. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to start of treatment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Leading Edge Research, PA
Arlington, Texas, 75213
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70809
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care Inc.
Cincinnati, Ohio, 45242
South Carolina Oncology Associates
Columbia, South Carolina, 29210
Florida Cancer Specialists
Fort Myers, Florida, 33916
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Tennessee Oncology
Nashville, Tennessee, 37203
Peninsula Cancer Institute
Newport News, Virginia, 23601
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
About this study
Official title: Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy
In this study, investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities.
Read the detailed description
The purpose of this study is to assess the efficacy, tolerability, and toxicity of bendamustine, bortezomib, and dexamethasone (BBD) as first-line treatment of multiple myeloma (MM) patients who are transplant ineligible or who are not candidates for high dose chemotherapy. Eligible patients will receive protocol treatment for up to 34 weeks plus the screening period (up to 2 weeks). Response assessments will occur every 4 weeks and confirmed using the International Myeloma Working Group Uniform Response Criteria. Patients having an objective response or stable disease will continue to maintenance therapy until disease progression or intolerable toxicity.
- Conditions
- Multiple Myeloma
- Being tested
- Bendamustine, Bortezomib, 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.
BendamustineDrug
Also called Treanda
Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
BortezomibDrug
Also called Velcade
1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15
DexamethasoneDrug
20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Bendamustine, Bortezomib,and Dexamethasone for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by IMWG criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone until disease progression or intolerable toxicity. Receives: Drug: Bendamustine; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.
Measured: every 8 weeks for approximately 48 months
Number of Patients Who Experienced Serious and Non-serious Adverse Events
All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.
Measured: approximately 36 weeks
Secondary outcomes (3)
Progression Free Survival
Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater.
Measured: every 8 weeks for up to 48 months
Overall Survival
Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive.
Measured: every 4 weeks until progressive disease then every 12 weeks, projected 48 months
Overall Response Rate
The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.
Measured: every 4 weeks for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2015
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Cephalon
- Responsible party
- Sponsor
- Investigators
- Jesus Berdeja, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056276
- Sponsor's protocol ID
- SCRI MM 23
- Status last verified
- Mar 2017
- First submitted
- 22 Jan 2010
- Last updated
- 3 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy
- ClinicalTrials.gov ID
- NCT01056276
- Acronym / sponsor ID
- SCRI MM 23
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Bendamustine, Bortezomib, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Cephalon
- Study start
- May 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities.
Detailed description
The purpose of this study is to assess the efficacy, tolerability, and toxicity of bendamustine, bortezomib, and dexamethasone (BBD) as first-line treatment of multiple myeloma (MM) patients who are transplant ineligible or who are not candidates for high dose chemotherapy. Eligible patients will receive protocol treatment for up to 34 weeks plus the screening period (up to 2 weeks). Response assessments will occur every 4 weeks and confirmed using the International Myeloma Working Group Uniform Response Criteria. Patients having an objective response or stable disease will continue to maintenance therapy until disease progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Bendamustine, Drug: Bortezomib, Drug: DexamethasoneBendamustine, Bortezomib,and Dexamethasone for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by IMWG criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must meet the Durie and Salmon criteria for initial diagnosis of multiple myeloma.
- Previously histologically confirmed, multiple myeloma with indication for therapy including one of the following:
- Patients should not be considered candidates for high dose therapy/autologous stem cell transplantation due to coexistent medical conditions, advanced age, poor performance status, refusal of high dose chemotherapy, or other reasons as judged by the patient and/or physician.
- ECOG Performance Status 0-2.
- WBC ≥3000/mL; ANC ≥1000/mL; platelets ≥50,000/mL (patients with platelets ≥30,000/mL are eligible if thrombocytopenia is felt to be due to extensive bone marrow involvement with myeloma).
Key exclusion criteria (18 listed)
- Previous therapy for multiple myeloma with the exception of an initial 4-day course of pulsed dexamethasone.
- Patients with ≥NCI CTCAE v4.0 grade 2 peripheral neuropathy ≤14 days prior to study enrollment.
- Treatment with investigational agent(s) ≤14 days prior to study enrollment.
- Active infection or infection requiring intravenous antibiotic treatment at the time of accrual.
- Known to be HIV positive (HIV test is not required for participation in the trial).
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: TreandaTreatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response. | Drug | Treatment |
| BortezomibAlso: Velcade1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response. Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15 | Drug | Treatment |
| Dexamethasone20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15 | Drug | Treatment |
Primary outcome
Complete Response Rate
Time frame: every 8 weeks for approximately 48 months
Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.
Number of Patients Who Experienced Serious and Non-serious Adverse Events
Time frame: approximately 36 weeks
All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.
3 secondary outcomes
Progression Free Survival
Time frame: every 8 weeks for up to 48 months
Overall Survival
Time frame: every 4 weeks until progressive disease then every 12 weeks, projected 48 months
Overall Response Rate
Time frame: every 4 weeks for approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jesus Berdeja, M.D. study chair
SCRI Development Innovations, LLC
13 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, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by SCRI Development Innovations, LLC at 13 sites in United States.
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 19 inclusion and 18 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Response Rate (time frame: every 8 weeks for approximately 48 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 May 2017.