Waldenstrom MacroglobulinemiaPhase 2WM2NCT00777738
Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
A Phase 2 study testing BORTEZOMIB in people with Waldenstrom Macroglobulinemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinemia
- What is being tested?
- BORTEZOMIB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Aug 2012
- 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
- ● Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia)
- Patient must have had 1 (or 2) lines of chemotherapy containing alkylating agent and/or Fludarabine :and /or monoclonal antibody and must have :
- Life expectancy > 3 months
- Age > 18 years
- ECOG performance status 0-1-2
- ANC > 1 x 109/L
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- Creatinine clearance, calculated according to the formula of cockcroft and Gault > 40 ml/min
- Total bilirubin < 2x ULN
- ASAT, ALAT < 2x ULN
- A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause
- Adequate contraceptive methods for males and pre-menopausal females for 6 months after treatment discontinuation.
- Written informed consent
- Platelets> 100X 109
Who cannot join
- Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Waldenström macroglobulinemia prior to the study
- Medical condition requiring the long-term (estimated to be more than one month) use of oral corticosteroids
- Patients with active bacterial, viral or fungal infection
- Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
- Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
- Lactation/pregnancy
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- Concurrent severe diseases which exclude the administration of therapy heart insufficiency NYHA grade III/IV, LEVF < 50% and or RF < 30%, myocardial infarction within the past 6 months prior to study
- Severe pulmonary or heart problems (acute diffuse pulmonary and pericardial disease)
- Severe chronic obstructive lung disease with hypoxemia
- Severe diabetes mellitus
- Hypertension difficult to control
- Impaired renal function with creatinine clearance < 40 ml/min according to the formula of Cockcroft and Gault
- Cerebral dysfunction
- Richter's syndrome
- Neuropathy> grade 1
- Positive Beta HCG
- Severe Hepato cellular alteration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease.
Read the detailed description
Open, prospective, multicenter, non controlled phase IIA trial
Primary objectives Evaluation of the efficacy and safety of Velcade in monotherapy for patients with advanced stage Waldenström Macroglobulinemia.
Secondary objectives Evaluation of the activity of the association of High Dose Dexamethasone (HD DXM) with Velcade for patients resistant to Velcade Alone For all patients
- Overall survival
- Safety
- Quality of life
- Duration of response sample size: With type I error alpha of 5% and type II error beta of 20% and a two-sided test, the number of patients needed in this study is 34 Number of centers: 28 Centers participating to the French cooperative group CLL/WM
- Conditions
- Waldenstrom Macroglobulinemia
- Being tested
- BORTEZOMIB
- Keywords
- Advanced Waldenström's macroglobulinemia, Bortezomib, Dexamethasone, Safety, Efficacy
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BORTEZOMIBDrug
- Bortezomib (Velcade(R)): 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days for 2 cycles (IV route, push).
- For responding patients : up to 6 cycles
- For non responding patient : Adjunction of dexamethasone (HD DXM) : 20 mg Days 1,D2, D 4,D 5, D8, D9 and D 11,D12 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| bortezomib | Experimental | bortezomib Receives: Drug: BORTEZOMIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
Measured: 3 months and 6 months
Secondary outcomes (3)
Duration of the response
Measured: during the study
Overall survival
Measured: during the study
Quality of life
Measured: months 0, 3, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique LEBLOND, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777738
- Sponsor's protocol ID
- P060207
- Acronym
- WM2
- Status last verified
- Oct 2008
- First submitted
- 16 Oct 2008
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
- ClinicalTrials.gov ID
- NCT00777738
- Acronym / sponsor ID
- WM2 / P060207
- Conditions
- Waldenstrom Macroglobulinemia
- Keywords
- Advanced Waldenström's macroglobulinemia, Bortezomib, Dexamethasone, Safety, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Oct 2008 (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 trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease.
Detailed description
Open, prospective, multicenter, non controlled phase IIA trial
Primary objectives Evaluation of the efficacy and safety of Velcade in monotherapy for patients with advanced stage Waldenström Macroglobulinemia.
Secondary objectives Evaluation of the activity of the association of High Dose Dexamethasone (HD DXM) with Velcade for patients resistant to Velcade Alone For all patients
- Overall survival
- Safety
- Quality of life
- Duration of response sample size: With type I error alpha of 5% and type II error beta of 20% and a two-sided test, the number of patients needed in this study is 34 Number of centers: 28 Centers participating to the French cooperative group CLL/WM
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bortezomib | Experimental | Drug: BORTEZOMIBbortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ● Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia)
- Patient must have had 1 (or 2) lines of chemotherapy containing alkylating agent and/or Fludarabine :and /or monoclonal antibody and must have :
- Life expectancy > 3 months
- Age > 18 years
- ECOG performance status 0-1-2
Key exclusion criteria (17 listed)
- Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Waldenström macroglobulinemia prior to the study
- Medical condition requiring the long-term (estimated to be more than one month) use of oral corticosteroids
- Patients with active bacterial, viral or fungal infection
- Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
- Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
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* Bortezomib (Velcade(R)): 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days for 2 cycles (IV route, push). * For responding patients : up to 6 cycles * For non responding patient : Adjunction of dexamethasone (HD DXM) : 20 mg Days 1,D2, D 4,D 5, D8, D9 and D 11,D12 every 21 days | Drug | bortezomib |
Primary outcome
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
Time frame: 3 months and 6 months
3 secondary outcomes
Duration of the response
Time frame: during the study
Overall survival
Time frame: during the study
Quality of life
Time frame: months 0, 3, 12, 24
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 Jan 2013.
Related trials for Waldenstrom Macroglobulinemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Not yet recruitingPhase 2
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
Waldenstrom Macroglobulinemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
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.
Véronique LEBLOND, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 in people with Waldenstrom Macroglobulinemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 13 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: finished, as of the sponsor's last update on 18 Jan 2013. 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 France. 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?
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia (time frame: 3 months and 6 months). 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 Jan 2013.