Multiple MyelomaPhase 2NCT01315873
Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma
A Phase 2 study testing Bendamustine and Bortezomib in people with Multiple Myeloma, run by NYU Langone Health at 1 site in United States.
Trial summary
Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib. 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 and Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2015
- 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
- Voluntary written informed consent
- Age 18 years or older
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Diagnosis of multiple myeloma based on standard criteria as follows:
- Major Criteria
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- Plasmacytomas on tissue biopsy
- Bone marrow plasmacytosis (>30% plasma cells)
- Monoclonal immunoglobulin spike on serum electrophoresis (IgG >3.5 g/dL or IgA >2.0 g/dL) or kappa or lambda light chain excretion >1 g/day on 24 hour urine protein electrophoresis
- Minor Criteria
- Bone marrow plasmacytosis (10 to 30% plasma cells)
- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- Lytic bone lesions
- Normal IgM <50 mg/dL, IgA <100 mg/dL, or IgG <600 mg/dL
- Any of the following sets of criteria will confirm the diagnosis of Multiple Myeloma:
- Any two of the major criteria or
- 1 major plus 2 minor criteria.
- Measurable disease, defined as a monoclonal immunoglobulin spike (M-Spike) on serum electrophoresis of ≥1 g/dL and/or urine monoclonal immunoglobulin spike of ≥200 mg/24 hours. Non-secretors must have measurable protein by Freelite or measurable disease by plasmacytoma to be eligible.
- Patients must have refractory myeloma as defined by a greater than 25% increase in their M-protein. They should have progressed on bortezomib.
- Karnofsky performance status ≥50
- Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require radiotherapy should have entry to the protocol deferred until the radiotherapy is completed by at least 4 weeks prior to initiation of study drug.
- Meets the following pretreatment laboratory criteria at baseline (Day 1 of Cycle 1, before study drug administration)
- Absolute neutrophil count ≥1 x 10^3/uL
- Platelet count ≥75 x 10^3/uL
- Hemoglobin ≥8.0 g/dL
- Calculated or measured CrCL ≥ 40 mL/min
- AST or ALT and total bilirubin < 3 x ULN
- Echocardiogram with a >50% Ejection Fraction
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be registered on study:
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Plasma cell leukemia
- Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
- Infection not controlled by antibiotics
- HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice.
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- Known active hepatitis B or C
- New York Hospital Association (NYHA) Class III or IV heart failure, Echo or MUGA ejection fraction < 40% (if known), or EKG evidence of acute ischemic disease
- Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
- Second malignancy requiring treatment in the last 3 years
- Patient has a calculated or measured creatinine clearance of <40 mL/min within 14 days before enrollment
- Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment
- Patient has hypersensitivity to bortezomib, boron or mannitol and bendamustine
- Positive pregnancy test in women of childbearing potential or subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum betaa human chorionic gonadotropin test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: Phase II Trial of Bortezomib and Bendamustine in the Treatment of Relapsed/Refractory Myeloma
Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib.
The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4 of each cycle, with bortezomib being given first, before each dose of bendamustine. Each cycle will be 28 days long, so patients will be treated the first week of each cycle and then have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22 of each cycle. Patients will receive the study drugs until their disease progresses or they are withdrawn from the study.
In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to show that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.
Read the detailed description
Patients with relapsed and refractory myeloma who have a measurable paraprotein in the serum or urine or measurable protein by Freelite or measurable disease by plasmacytoma will be given a combination of bendamustine and bortezomib each cycle. Response rate (PR or better after 2 cycles) and duration of response will be assessed. Therapy will be continued until disease progression. The bendamustine would be used in a day 1, day 4 dosing schedule after each dose of bortezomib to take advantage of the chemosensitizing properties of bortezomib. This minimizes the days of treatment to just the first week and allows rebound of blood counts. This will be a phase II trial with dose reduction as necessary.
Bendamustine is a drug which appears to be non-cross-resistant with other alkylating agents in vitro and in vivo. Thus, we hypothesize that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Bendamustine, Bortezomib
- Keywords
- myeloma, multiple myeloma, relapsed myeloma, refractory myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Bendamustine HCl, Treanda
On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.
Patients will be treated until disease progression after at least one cycle of treatment.
BortezomibDrug
Also called Velcade
On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.
Patients will be treated until disease progression after at least one cycle of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib and Bendamustine | Experimental | Not described Receives: Drug: Bendamustine; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine
These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)
Measured: 8 weeks
Secondary outcomes (2)
Toxicity of This Regimen.
Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.
Measured: Every 4 weeks.
Duration of Response of This Regimen.
Time from response to relapse. Response would have been assessed using European Group for Blood and Marrow Transplantation (EBMT) criteria modified to include near complete remission (nCR) and very good partial remission (VGPR
Measured: from initial response to relapse, up to 100 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionSep 2015
Why it stopped: PI left the institution before all data analysis was completed
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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Amitabha Mazumder, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315873
- Sponsor's protocol ID
- 10-02009
- Status last verified
- Jan 2018
- First submitted
- 14 Mar 2011
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bortezomib and Bendamustine in the Treatment of Relapsed/Refractory Myeloma
- ClinicalTrials.gov ID
- NCT01315873
- Acronym / sponsor ID
- 10-02009
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, multiple myeloma, relapsed myeloma, refractory myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution before all data analysis was completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Posted 8 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib.
The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4 of each cycle, with bortezomib being given first, before each dose of bendamustine. Each cycle will be 28 days long, so patients will be treated the first week of each cycle and then have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22 of each cycle. Patients will receive the study drugs until their disease progresses or they are withdrawn from the study.
In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to show that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.
Detailed description
Patients with relapsed and refractory myeloma who have a measurable paraprotein in the serum or urine or measurable protein by Freelite or measurable disease by plasmacytoma will be given a combination of bendamustine and bortezomib each cycle. Response rate (PR or better after 2 cycles) and duration of response will be assessed. Therapy will be continued until disease progression. The bendamustine would be used in a day 1, day 4 dosing schedule after each dose of bortezomib to take advantage of the chemosensitizing properties of bortezomib. This minimizes the days of treatment to just the first week and allows rebound of blood counts. This will be a phase II trial with dose reduction as necessary.
Bendamustine is a drug which appears to be non-cross-resistant with other alkylating agents in vitro and in vivo. Thus, we hypothesize that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib and Bendamustine | Experimental | Drug: Bendamustine, Drug: Bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Voluntary written informed consent
- Age 18 years or older
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Diagnosis of multiple myeloma based on standard criteria as follows:
Key exclusion criteria (17 listed)
- Patients meeting any of the following exclusion criteria are not to be registered on study:
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Plasma cell leukemia
- Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
- Infection not controlled by antibiotics
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: Bendamustine HCl, TreandaOn days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment. | Drug | Bortezomib and Bendamustine |
| BortezomibAlso: VelcadeOn days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment. | Drug | Bortezomib and Bendamustine |
Primary outcome
Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine
Time frame: 8 weeks
These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)
2 secondary outcomes
Toxicity of This Regimen.
Time frame: Every 4 weeks.
Duration of Response of This Regimen.
Time frame: from initial response to relapse, up to 100 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- 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.
Amitabha Mazumder, MD principal investigator
NYU Langone Health
1 site 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 and Bortezomib in people with Multiple Myeloma, run by NYU Langone Health at 1 site 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 28 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 Dec 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?
Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine (time frame: 8 weeks). 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 7 Feb 2018.