Multiple MyelomaPhase 2NCT00337506
Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing Dexamethasone and velcade in people with Multiple Myeloma, run by Nantes University Hospital at 1 site in France.
Trial summary
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Dexamethasone and velcade
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2003to not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of MM according to the SWOG criteria (annex 1)
- previously untreated (localized radiotherapy is allowed)
- symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
- with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h)
- age < 75 years
- able to understand and to given an informed consent
- male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
- no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.
Who cannot join
- life expectancy < 2 months
- ECOG performance status > 2 (annex 3)
- proven amyloidosis
- positive HIV serology
- antecedents of severe psychiatric disease
- severe diabetes contraindicating the use of high-dose corticoïds
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- > NCI grade 2 peripheral neuropathy (Annex IV)
- serum biochemical values as follow
- creatinin level > 200mmol/l
- bilirubin, transaminases or gGT > 3 the upper normal limit
- use of any experimental drugs within 30 days of baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.
- Conditions
- Multiple Myeloma
- Being tested
- Dexamethasone, velcade
- Keywords
- the efficacy and safety of Velcade plus dexamethasone, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
velcadeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission after 4 cycles:
disappearance of serum and/or urine M-component (confirmed by immunofixation)
< 5% plasma cells in the bone marrow resolution of all extra-osseous plasmacytomas
no evidence of bone progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startAug 2003
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.
- More trials run by Nantes University HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Luc HAROUSSEAU, MD, Principal investigator, NANTES UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337506
- Sponsor's protocol ID
- BRD 03/6-E
- Status last verified
- Aug 2004
- First submitted
- 14 Jun 2006
- Last updated
- 16 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00337506
- Acronym / sponsor ID
- BRD 03/6-E
- Conditions
- Multiple Myeloma
- Keywords
- the efficacy and safety of Velcade plus dexamethasone, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Aug 2003
- First posted
- 16 Jun 2006 (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.
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of MM according to the SWOG criteria (annex 1)
- previously untreated (localized radiotherapy is allowed)
- symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
- with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h)
- age < 75 years
Key exclusion criteria (11 listed)
- life expectancy < 2 months
- ECOG performance status > 2 (annex 3)
- proven amyloidosis
- positive HIV serology
- antecedents of severe psychiatric disease
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 |
|---|---|---|
| Dexamethasone | Drug | – |
| velcade | Drug | – |
Primary outcome
Complete remission after 4 cycles:
disappearance of serum and/or urine M-component (confirmed by immunofixation)
< 5% plasma cells in the bone marrow resolution of all extra-osseous plasmacytomas
no evidence of bone progression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2006.
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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.
Jean-Luc HAROUSSEAU, MD principal investigator
NANTES UH
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 Dexamethasone and velcade in people with Multiple Myeloma, run by Nantes University Hospital 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 8 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: stopped early, as of the sponsor's last update on 16 Jun 2006. 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 was stopped early. Results are not available in the source record.
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 remission after 4 cycles:. The study lists 4 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 16 Jun 2006.