Waldenstroms MacroglobulinemiaPhase 2BDR-WMNCT00832234
Bortezomib, Dexamethasone, and Rituximab in Untreated Waldenstroms Macroglobulinemia
A Phase 2 study testing Bortezomib, Dexamethasone, Rituximab in people with Waldenstroms Macroglobulinemia, run by European Myeloma Network B.V. at 1 site in Greece.
Trial summary
This is a Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstroms Macroglobulinemia
- What is being tested?
- Bortezomib, Dexamethasone, Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2006to Jun 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
- Each patient must meet all of the following inclusion criteria to be enrolled in this study:
- Clinicopathological diagnosis of Waldenstroms macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstroms macroglobulinemia.
- All patients with the diagnosis of WM will be evaluable for response according to the response criteria
- No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed. In that case baseline monoclonal protein levels for assessment of response will be the levels prior to plasmapheresis, if this is the higher value prior to treatment initiation
- Patients must have at least one of the following indications to initiate treatment as defined by Consensus Panel Two recommendations from the Second -
- International Workshop on Waldenstroms Macroglobulinemia.
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- Recurrent fever, night sweats, weight loss, fatigue
- Hyperviscosity
- Lymphadenopathy which is either symptomatic or bulky (>5cm in maximum diameter)
- Symptomatic hepatomegaly and/or splenomegaly
- Symptomatic organomegaly and/or organ or tissue infiltration
- Peripheral neuropathy due to WM
- Symptomatic cryoglobulinemia
- Cold agglutinin anemia
- Immune hemolytic anemia and/or thrombocytopenia
- Nephropathy related to WM
- Amyloidosis related to WM
- Hemoglobin < 10g/dL
- Platelet count < 100x109/L
- Serum monoclonal protein >5g/dL even with no symptoms
- CD20 positive disease based on any previous bone marrow immunohistochemistry or flow cytometric analysis performed up to 3 months prior to enrollment.
- Karnofsky performance status more than 60.
- Life-expectancy >3 months.
- Baseline platelet count more than 50x109/L, and absolute neutrophil count more than 0.75x109/L.
- Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment:
- AST (SGOT): less than 3 times the upper limit of institutional laboratory normal.
- ALT (SGPT): less than 3 times the upper limit of institutional laboratory normal.
- Total Bilirubin: less than 2 times the upper limit of institutional laboratory normal, unless clearly related to the disease.
- Calculated or measured creatinine clearance: less than 30 mL/minute. Serum sodium >130 mmol/L.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Prior systemic treatment with WM (plasmapheresis is allowed)
- Myocardial infarction within 6 months prior to enrollment or has New York
- Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
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- Cardiac amyloidosis
- Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI - CTCAE version 3
- Women who are pregnant.
- Women who are breast-feeding and do not consent to discontinue breast-feeding.
- Women of childbearing age who are not willing to use effective anti-conceptive methods for the duration of the study and 6 months thereafter.
- Men who do not consent not to father a child during the treatment period and six months thereafter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstroms Macroglobulinemia: A Multicenter Trial of the European Myeloma Network
This is a Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM.
Read the detailed description
Title: Phase II Study of Combination Bortezomib (VELCADE, PS-341), Dexamethasone, and Rituximab (MabThera) (BDR) in Patients with previously untreated Waldenstroms Macroglobulinemia (WM).
Objectives:
The primary objective of this study is:
- To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
Secondary objectives are:
- To determine time to progression following treatment with BDR.
- To assess the safety and tolerability of BDR in patients with WM.
Patient population:
Patients with previously untreated WM who have an indication for treatment are candidates for the study.
Specific inclusion and exclusion criteria are detailed in the protocol.
Number of patients:
Sixty-one patients are to be enrolled in this multicenter study. This study will be conducted within centers participating in the European Myeloma Network.
Study design and methodology This is a Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv will be administered. A total of 8 infusions of rituximab will be administered. Subsequently patients rated as CR, PR, MR or SD will be followed without any treatment until there is evidence of progressive disease.
A Screening visit will be conducted within 28 days before baseline (baseline being Day 1, Cycle 1, before study drug administration). At this visit, a medical history will be obtained and a complete physical examination will be performed including vital signs, height, weight, and a 12-lead electrocardiogram. A neurological questionnaire will also be completed. Disease assessments will be performed, including performance status, bone marrow aspirate and biopsy, Beta2-microglobulin, serum protein electrophoresis with quantification of immunoglobulins and immunofixation studies, CT scanning of the chest, abdomen and pelvis. Clinical laboratory tests including a complete blood count plus differential, electrolytes, urea, creatinine, total bilirubin, SGOT (ALT), SGPT (AST), LDH, total protein and albumin. Patients who meet the eligibility requirements as assessed at the Screening visit will be enrolled in the study and start study drug treatment. Patients will be evaluated after each cycle with serum protein electrophoresis to determine their response to therapy. If patients demonstrate a response or have stable disease at the end of each cycle they will continue to receive therapy. If the patient demonstrates evidence of progressive disease at the end of each cycle then the patient will be removed from study. Modified response criteria updated at the Third International Workshop on Waldenstroms macroglobulinemia will be used to assess response, stable disease (SD), and progressive disease (PD) in this study. Changes of serum monoclonal protein concentration will be assessed from serum protein electrophoresis rather than from nephelometric measurement of serum immunoglobulins. Patients will receive five cycles of therapy. Subsequently, it is strongly advised that blood stem cells will be collected from patients <70 years of age for future high-dose therapy.
At the end of each cycle patients will have testing performed to assess for toxicity and efficacy. A directed questionnaire for neurologic toxicities, review of concomitant medications and other support therapies, including growth factors and transfusions will also be performed. Three months after the last dose of study drug, and every three months thereafter for 2 years, patients are to attend follow-up study visits. At these visits, a physical examination will be performed and Karnofsky performance status assessed. Patients will have a neurological questionnaire completed, have tests for disease assessments including serum and protein electrophoresis with quantification of immunoglobulins and immunofixation studies, Beta2-microglobulin, bone marrow aspirate and biopsy (only if the patient is in a complete remission), CT scanning of the chest, abdomen and pelvis (only if patient had evidence of WM disease on baseline scans). Serum and protein electrophoresis with quantification of immunoglobulins and immunofixation studies must be repeated > 6 weeks if a patient attains a complete response. At the follow-up study visits, a complete blood count plus differential, electrolytes, urea, creatinine, total bilirubin, SGOT, will also be obtained.
- Conditions
- Waldenstroms Macroglobulinemia
- Being tested
- Bortezomib, Dexamethasone, Rituximab
- Keywords
- Morbus Waldenstrom, Waldenstroms Macroglobulinemia, Therapy, Rituximab, Dexamethasone, Bortezomib
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib, Dexamethasone, RituximabDrug
Also called Velcade, MabThera
The combination of bortezomib, dexamethasone and rituximab will be administered in five treatment cycles. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle one. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of bortezomib, dexamethasone 40mg IV and rituximab 375mg/m2 IV will be administered. A total of 8 infusions of rituximab will be administered. The administration of bortezomib before rituximab may abrogate the IgM flare phenomenon that occurs frequently after the first course of rituximab.
| Study group | Role | What they receive |
|---|---|---|
| BDR | Experimental | Not described Receives: Drug: Bortezomib, Dexamethasone, Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
Measured: Two years
Secondary outcomes (1)
Time to progression following treatment with BDR The safety and tolerability of BDR in patients with WM.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startSep 2006
- Primary completionJun 2010
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstroms MacroglobulinemiaStudies 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
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- University of Athens, University of Roma La Sapienza, Niguarda Hospital, University of Turin, Italy, University of Salamanca, Hospital Clinic of Barcelona, Hotel Dieu Hospital, Erasmus Medical Center, University Hospital, Toulouse, Fondazione IRCCS Policlinico San Matteo di Pavia, Laikο General Hospital, Athens, Klinikum der Universitaet Muenchen, Grosshadern, Aalborg University Hospital, Centre Hospitalier de Lens, Universitaire Ziekenhuizen KU Leuven, Theagenio Cancer Hospital, University of Wuerzburg, Skane University Hospital, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Professor Hans Erik Johnsen, European Myeloma Network B.V.
- Investigators
- Meletios A Dimopoulos, MD, Principal investigator, University of Athens School of Medicine, Alexandra Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832234
- Sponsor's protocol ID
- EMN-01 (26866138CAN 2021)
- Other IDs
- EudraCT-nr. 2006-003563-31
- Acronym
- BDR-WM
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2009
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstroms Macroglobulinemia: A Multicenter Trial of the European Myeloma Network
- ClinicalTrials.gov ID
- NCT00832234
- Acronym / sponsor ID
- BDR-WM / EMN-01 (26866138CAN 2021)
- Conditions
- Waldenstroms Macroglobulinemia
- Keywords
- Morbus Waldenstrom, Waldenstroms Macroglobulinemia, Therapy, Rituximab, Dexamethasone, Bortezomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- University of Athens, University of Roma La Sapienza, Niguarda Hospital, University of Turin, Italy, University of Salamanca, Hospital Clinic of Barcelona, Hotel Dieu Hospital, Erasmus Medical Center, University Hospital, Toulouse, Fondazione IRCCS Policlinico San Matteo di Pavia, Laikο General Hospital, Athens, Klinikum der Universitaet Muenchen, Grosshadern, Aalborg University Hospital, Centre Hospitalier de Lens, Universitaire Ziekenhuizen KU Leuven, Theagenio Cancer Hospital, University of Wuerzburg, Skane University Hospital, Sahlgrenska University Hospital
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Jan 2009 (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 Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM.
Detailed description
Title: Phase II Study of Combination Bortezomib (VELCADE, PS-341), Dexamethasone, and Rituximab (MabThera) (BDR) in Patients with previously untreated Waldenstroms Macroglobulinemia (WM).
Objectives:
The primary objective of this study is:
- To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
Secondary objectives are:
- To determine time to progression following treatment with BDR.
- To assess the safety and tolerability of BDR in patients with WM.
Patient population:
Patients with previously untreated WM who have an indication for treatment are candidates for the study.
Specific inclusion and exclusion criteria are detailed in the protocol.
Number of patients:
Sixty-one patients are to be enrolled in this multicenter study. This study will be conducted within centers participating in the European Myeloma Network.
Study design and methodology This is a Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv will be administered. A total of 8 infusions of rituximab will be administered. Subsequently patients rated as CR, PR, MR or SD will be followed without any treatment until there is evidence of progressive disease.
A Screening visit will be conducted within 28 days before baseline (baseline being Day 1, Cycle 1, before study drug administration). At this visit, a medical history will be obtained and a complete physical examination will be performed including vital signs, height, weight, and a 12-lead electrocardiogram. A neurological questionnaire will also be completed. Disease assessments will be performed, including performance status, bone marrow aspirate and biopsy, Beta2-microglobulin, serum protein electrophoresis with quantification of immunoglobulins and immunofixation studies, CT scanning of the chest, abdomen and pelvis. Clinical laboratory tests including a complete blood count plus differential, electrolytes, urea, creatinine, total bilirubin, SGOT (ALT), SGPT (AST), LDH, total protein and albumin. Patients who meet the eligibility requirements as assessed at the Screening visit will be enrolled in the study and start study drug treatment. Patients will be evaluated after each cycle with serum protein electrophoresis to determine their response to therapy. If patients demonstrate a response or have stable disease at the end of each cycle they will continue to receive therapy. If the patient demonstrates evidence of progressive disease at the end of each cycle then the patient will be removed from study. Modified response criteria updated at the Third International Workshop on Waldenstroms macroglobulinemia will be used to assess response, stable disease (SD), and progressive disease (PD) in this study. Changes of serum monoclonal protein concentration will be assessed from serum protein electrophoresis rather than from nephelometric measurement of serum immunoglobulins. Patients will receive five cycles of therapy. Subsequently, it is strongly advised that blood stem cells will be collected from patients <70 years of age for future high-dose therapy.
At the end of each cycle patients will have testing performed to assess for toxicity and efficacy. A directed questionnaire for neurologic toxicities, review of concomitant medications and other support therapies, including growth factors and transfusions will also be performed. Three months after the last dose of study drug, and every three months thereafter for 2 years, patients are to attend follow-up study visits. At these visits, a physical examination will be performed and Karnofsky performance status assessed. Patients will have a neurological questionnaire completed, have tests for disease assessments including serum and protein electrophoresis with quantification of immunoglobulins and immunofixation studies, Beta2-microglobulin, bone marrow aspirate and biopsy (only if the patient is in a complete remission), CT scanning of the chest, abdomen and pelvis (only if patient had evidence of WM disease on baseline scans). Serum and protein electrophoresis with quantification of immunoglobulins and immunofixation studies must be repeated > 6 weeks if a patient attains a complete response. At the follow-up study visits, a complete blood count plus differential, electrolytes, urea, creatinine, total bilirubin, SGOT, will also be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BDR | Experimental | Drug: Bortezomib, Dexamethasone, Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in this study:
- Clinicopathological diagnosis of Waldenstroms macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstroms macroglobulinemia.
- All patients with the diagnosis of WM will be evaluable for response according to the response criteria
- No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed. In that case baseline monoclonal protein levels for assessment of response will be the levels prior to plasmapheresis, if this is the higher value prior to treatment initiation
- Patients must have at least one of the following indications to initiate treatment as defined by Consensus Panel Two recommendations from the Second -
Key exclusion criteria (12 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Prior systemic treatment with WM (plasmapheresis is allowed)
- Myocardial infarction within 6 months prior to enrollment or has New York
- Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol.
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 |
|---|---|---|
| Bortezomib, Dexamethasone, RituximabAlso: Velcade, MabTheraThe combination of bortezomib, dexamethasone and rituximab will be administered in five treatment cycles. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle one. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of bortezomib, dexamethasone 40mg IV and rituximab 375mg/m2 IV will be administered. A total of 8 infusions of rituximab will be administered. The administration of bortezomib before rituximab may abrogate the IgM flare phenomenon that occurs frequently after the first course of rituximab. | Drug | BDR |
Primary outcome
The response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
Time frame: Two years
1 secondary outcome
Time to progression following treatment with BDR The safety and tolerability of BDR in patients with WM.
Time frame: Two years
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 18 Feb 2015.
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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.
Meletios A Dimopoulos, MD principal investigator
University of Athens School of Medicine, Alexandra Hospital, Athens, Greece
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 Bortezomib, Dexamethasone, Rituximab in people with Waldenstroms Macroglobulinemia, run by European Myeloma Network B.V. at 1 site in Greece.
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 30 inclusion and 12 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 18 Feb 2015. 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 Greece. 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?
The response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM. (time frame: Two years). 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 18 Feb 2015.