Multiple MyelomaPhase 2NCT00642395
Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)
A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by University Hospital, Toulouse at 34 sites in France.
Trial summary
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). 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?
- Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 34 sitesFrance
- Study dates
- Jul 2007to Jul 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At time of diagnosis
- De novo multiple myeloma patients under 65 or in first relapse, in whom screening for chromosome 13 deletion and beta2microglobulin assay have been performed.
- Salmon and Durie Stage: III, II, I with symptomatic bone lesion (radiological)
- Patient's written informed consent
- No clinical signs of heart failure or coronary insufficiency with LVEF>50%
- No hepatic in insufficiency: bilirubin<35μmol/l and SGOT, SGPT, alkaline phosphatase less than 2.5 N
Show all 16Show fewer
- No respiratory insufficiency: normal pulmonary function tests and DLCO>50%
- No pre-existing renal impairment not related to the disease
- No history of any other malignant disease with the exception of basal cell carcinoma and stage I cervical cancer
- Negative HIV serology
- Effective contraception when justified
- At the time of transplantation
- Good performance status (WHO score≤2)
- Creatinine≤170μmol/l and no ineligibility criteria for intensification
- Stem cells harvest ≥ 5x10E6 CD34/kg for 2 ASCT
- Absence of progressive disease before transplantation
Who cannot join
- Known refusal of the subject to participate to the study
- Female subject who is pregnant or breast-feeding
- History of allergy to any of the study medications, their analogues, or excipients in the various formulations
- Main liver insufficiency
- ≥ Grade 3 peripheral neuropathy on clinical examination within 14 days before enrollment
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
France34 sites
Service of Blood Deseases - South Hospital
Amiens, 80054
Service of Clinical Hematology - Bocage Hospital
Angers, 49033
Service of Clinical Hematology - Cote Basque Hospital
Bayonne, 64109
Service of Clinical Hematology - Minjoz Hospital
Besançon, 25030
Service of Clinical Hematology - Avicenne Hospital
Bobigny, 93009
Service of Clinical Hematology - A. Morvan Hospital
Brest, 29609
Service of Clinical Hematology - F. Baclesse Center
Caen, 14076
Service of Clinical Hematology - Army Instruction Hospital of Percy
Clamart, 92141
Service of Clinical Hematology - UH of Clermont-Ferrand
Clermont-Ferrand, 63003
Service of Oncohematology - Louis Pasteur Hospital
Colmar, 68024
Service of Hematology - Bocage Hospital
Dijon, 21034
Service of Hematology - General Hospital
Dunkirk, 59385
Service of Hematology - A. Michallon Hospital
Grenoble, 38043
Service of Hematology - Claude Hurriez Hospital
Lille, 59037
Service of Hematology - Léon Bérard Center
Lyon, 69008
Service of Hematology - Edouard Herriot Hospital
Lyon, 69437
Service of Hematology - Lyon Sud Hospital
Lyon, 69495
Service of Hematology - Paoli Calmette Institute
Marseille, 13273
Service of Hematology - Notre Dame du Bon Secours Hospital
Metz, 57038
Service of Blood Deseases - UH of Nantes
Nantes, 44035
Service of Clinical Hematology - Archet 1 Hospital
Nice, 06202
Service of Oncology - Archet 1 Hospital
Nice, 06202
Service of Hematology - Hotel Dieu
Paris, 75004
Service of Hematology - Cochin Hospital
Paris, 75014
Service of Blood Deseases - Saint Antoine Hospital
Paris, 75571
Service of Hematology - Jean Bernard Hospital
Poitiers, 86021
Service of Hematology - R.Debré Hospital
Reims, 51032
Service of Hematology - Pontchaillou Hospital
Rennes, 35033
Service of Hematology -Henri Becquerel Center
Rouen, 76038
Service of Hematology - Hautepierre Hospital
Strasbourg, 67098
Service of Clinical Hematology - Purpan hospital TSA 40031
Toulouse, 31059
Service of Onco-Hematology - Bretonneau Hospital
Tours, 37044
Service of Hematology - Brabois Hospital
Vandœuvre-lès-Nancy, 54511
Service of Hematology -Gustave Roussy Institute
Villejuif, 94805
About this study
Official title: Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease.
Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.
Read more
This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included.
Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis.
After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation.
Evaluation will occur at 3 months post intensification.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib
- Keywords
- Multiple Myeloma, Autologous Stem Cells Transplantation, High Dose Melphalan, Bortezomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
bortezomib-Melphalan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | bortézomib Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Complete Response and Very Good Partial Response (VGPR) rates 3 months after autologous blood stem cell transplantation conditioned by Velcade-Melphalan
Measured: 3 months after autologous stem cell transplantation
Secondary outcomes (1)
Assess the toxicity of this Velcade-Melphalan conditioning regimen (hematological and visceral toxicity-NCI criteria) - To assess the progression-free survival after transplantation - To assess the overall survival after tran
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionJul 2011
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.
- More trials run by University Hospital, ToulouseThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome
- Responsible party
- Sponsor
- Investigators
- Murielle ROUSSEL, MD, Principal investigator, Purpan Hospital - UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642395
- Sponsor's protocol ID
- 0603603
- Status last verified
- May 2017
- First submitted
- 13 Mar 2008
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pegourie B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myelome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.
PubMed 19884643
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years
- ClinicalTrials.gov ID
- NCT00642395
- Acronym / sponsor ID
- 0603603
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Autologous Stem Cells Transplantation, High Dose Melphalan, Bortezomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Mar 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.
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease.
Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.
This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included.
Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis.
After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation.
Evaluation will occur at 3 months post intensification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bortezomibbortézomib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At time of diagnosis
- De novo multiple myeloma patients under 65 or in first relapse, in whom screening for chromosome 13 deletion and beta2microglobulin assay have been performed.
- Salmon and Durie Stage: III, II, I with symptomatic bone lesion (radiological)
- Patient's written informed consent
- No clinical signs of heart failure or coronary insufficiency with LVEF>50%
Key exclusion criteria (5 listed)
- Known refusal of the subject to participate to the study
- Female subject who is pregnant or breast-feeding
- History of allergy to any of the study medications, their analogues, or excipients in the various formulations
- Main liver insufficiency
- ≥ Grade 3 peripheral neuropathy on clinical examination within 14 days before enrollment
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 |
|---|---|---|
| BortezomibAlso: Velcadebortezomib-Melphalan | Drug | 1 |
Primary outcome
Evaluate the Complete Response and Very Good Partial Response (VGPR) rates 3 months after autologous blood stem cell transplantation conditioned by Velcade-Melphalan
Time frame: 3 months after autologous stem cell transplantation
1 secondary outcome
Assess the toxicity of this Velcade-Melphalan conditioning regimen (hematological and visceral toxicity-NCI criteria) - To assess the progression-free survival after transplantation - To assess the overall survival after tran
Time frame: 3 months
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 12 May 2017.
- Results publication: PubMed 19884643Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pegourie B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myelome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.
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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.
Murielle ROUSSEL, MD principal investigator
Purpan Hospital - UH Toulouse
34 sites 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 Multiple Myeloma, run by University Hospital, Toulouse at 34 sites 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 16 inclusion and 5 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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?
Evaluate the Complete Response and Very Good Partial Response (VGPR) rates 3 months after autologous blood stem cell transplantation conditioned by Velcade-Melphalan (time frame: 3 months after autologous stem cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642395, 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 12 May 2017.