Multiple MyelomaPhase 3NCT00910897
Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
A Phase 3 study testing Velcade-Dexamethasone and Velcade-Thalidomide-Dexamethasone in people with Multiple Myeloma, run by Intergroupe Francophone du Myelome at 56 sites in 2 countries.
Trial summary
Primary objective: Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD. Secondary objectives: Compare the following parameters following 4 cycles of VD or VTD induction treatment: CR rate+ very good partial remission… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Velcade-Dexamethasone and Velcade-Thalidomide-Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 56 sitesin 2 countries
- Study dates
- Mar 2008to Aug 2009
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed symptomatic multiple myeloma (MM) patient
- Aged under 65
- Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
- Using effective contraceptive methods (for fertile men, women of childbearing potential)
- Provision of informed consent
- No evidence of active infection
Who cannot join
- Asymptomatic MM
- Non-secretory MM
- Aged 66 years or over
- ECOG performance status over 2 (see Appendix 2)
- Proven amyloidosis
- A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
Show all 20Show fewer
- Positive HIV serology
- A personal medical history of severe psychiatric disease
- Severe diabetes contraindicating the use of high-dose dexamethasone
- NCI grade ³ 2 peripheral neuropathy
- Serum clinical chemistry:
- creatinine level > 300 µmol/L or requiring dialysis
- bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL)
- Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
- Radiation therapy in the 2 weeks preceding randomization
- A personal medical history of allergic reactions to compounds containing boron or mannitol
- Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure
- Use of any investigational drug in the 30 days preceding randomization
- Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
- Severe pulmonary troubles (including acute infiltrative pneumopathy)
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
France49 sites
Chu Angers
Angers
CH Annecy
Annecy
Ch Avignon
Avignon
CH Bayonne
Bayonne
Chu Besancon
Besançon
CH BLOIS
Blois
Bobigny Avicenne
Bobigny
Chu Bordeaux
Bordeaux
Chu Brest
Brest
Caen M Interne Baclèse
Caen
CH Chartres
Chartres
Clamart Percy
Clamart
CHU Clermont Ferrand
Clermont-Ferrand
Ch Colmar
Colmar
Chu Dijon
Dijon
Ch Dunkerque
Dunkirk
Chu Grenoble
Grenoble
CH La Roche Sur Yon
La Roche-sur-Yon
Le Mans Victor Hugo
Le Mans
Chru Lille
Lille
Ch Lorient
Lorient
CHU Lyon Edouard Herriot
Lyon
CHU Lyon Sud Pierre Benite
Lyon
Lyon Léon Berard
Lyon
Marseille IPC
Marseille
CHR Metz Bonsecours
Metz
Chu Nancy
Nancy
Chu Nantes
Nantes
Nantes Catherine De Sienne
Nantes
CHU Nice M Interne
Nice
CHR Orléans
Orléans
Paris Cochin
Paris
Paris Hôtel Dieu
Paris
Paris Necker
Paris
Paris St Antoine
Paris
Paris St Louis
Paris
CHU Poitiers hemato
Poitiers
CHU Reims
Reims
CHU Rennes Hemato
Rennes
CHU Rennes M interne
Rennes
CH Roanne
Roanne
Rouen Becquerel
Rouen
CH St Brieuc
Saint-Brieuc
St ETIENNE
Saint-Etienne
CHRU Strasbourg
Strasbourg
Chu Toulouse
Toulouse
CHU Tours
Tours
CH Valence
Valence
CH Vannes
Vannes
Belgium7 sites
ANVERS Centrumziekenhuis
Antwerp
Anvers Uza
Antwerp
Bruxelles Erasme
Brussels
Bruxelles I Bordet
Brussels
BRUXELLES St LUC
Brussels
GILLY
Gilly
YVOIR MontGodinne
Yvoir
About this study
Official title: A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Primary objective:
- Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.
Secondary objectives:
- Compare the following parameters following 4 cycles of VD or VTD induction treatment:
- CR rate+ very good partial remission (VGPR) rate
- Overall remission rate (CR + VGPR + partial remission (PR) rate)
- K/l light chain ratio in patients in CR.
- Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
- Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).
- Conditions
- Multiple Myeloma
- Being tested
- Velcade-Dexamethasone, Velcade-Thalidomide-Dexamethasone
- Keywords
- Newly Diagnosed, multiple myeloma, induction, Thalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade-DexamethasoneDrug
Velcade-Thalidomide-DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Velcade-Dexamethasone | Active comparator | Not described Receives: Drug: Velcade-Dexamethasone |
| Velcade-Thalidomide-Dexamethasone | Active comparator | Not described Receives: Drug: Velcade-Thalidomide-Dexamethasone |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startMar 2008
- Primary completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910897
- Sponsor's protocol ID
- IFM 2007-02
- Other IDs
- Eudract 2007-005204-40
- Status last verified
- May 2009
- First submitted
- 29 May 2009
- Last updated
- 1 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pegourie B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traulle C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.
PubMed 21849487
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00910897
- Acronym / sponsor ID
- IFM 2007-02
- Conditions
- Multiple Myeloma
- Keywords
- Newly Diagnosed, multiple myeloma, induction, Thalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Intergroupe Francophone du MyelomeResearch network
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (estimated)
- First posted
- 1 Jun 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.
Primary objective:
- Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.
Secondary objectives:
- Compare the following parameters following 4 cycles of VD or VTD induction treatment:
- CR rate+ very good partial remission (VGPR) rate
- Overall remission rate (CR + VGPR + partial remission (PR) rate)
- K/l light chain ratio in patients in CR.
- Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
- Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Velcade-Dexamethasone | Active comparator | Drug: Velcade-Dexamethasone |
| Velcade-Thalidomide-Dexamethasone | Active comparator | Drug: Velcade-Thalidomide-Dexamethasone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed symptomatic multiple myeloma (MM) patient
- Aged under 65
- Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
- Using effective contraceptive methods (for fertile men, women of childbearing potential)
- Provision of informed consent
Key exclusion criteria (20 listed)
- Asymptomatic MM
- Non-secretory MM
- Aged 66 years or over
- ECOG performance status over 2 (see Appendix 2)
- Proven amyloidosis
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 |
|---|---|---|
| Velcade-Dexamethasone | Drug | Velcade-Dexamethasone |
| Velcade-Thalidomide-Dexamethasone | Drug | Velcade-Thalidomide-Dexamethasone |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2009.
- Derived from this study: PubMed 21849487Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pegourie B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traulle C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Velcade-Dexamethasone and Velcade-Thalidomide-Dexamethasone in people with Multiple Myeloma, run by Intergroupe Francophone du Myelome at 56 sites in 2 countries.
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 6 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in France, Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00910897, which also lists 1 linked publication.
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 1 Jun 2009.