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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003174-27 | EudraCT Number |
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This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.
Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.
The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma.
in each treatment arm there will be :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) | Active Comparator | Arm A:
|
|
| VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) | Active Comparator | For arm B:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide® | Drug |
| ||
| Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Response assessment according to the criteria IMWG | compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD | 15-17 month |
| Measure | Description | Time Frame |
|---|---|---|
| Response assessment according to the criteria IMWG | compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG) | 15 - 17 month |
| Number of Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of three techniques for the quantification of urinary monoclonal components in patients with Newly Diagnosed Multiple Myeloma. | The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma. Urinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE). The objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques. |
Inclusion Criteria:
Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient
- 18 ≤ age < 66 years
- Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2
- Patients must be eligible for Autologous Stem Cell Transplantation
- Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day
- Female patients of child-bearing potential (FCBP):
- Male Patients:
- All patients must:
- Patients must be capable of giving informed consent
- Patients must be affiliated with French social security system
Exclusion Criteria:
22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines
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| Name | Affiliation | Role |
|---|---|---|
| Philippe MOREAU | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | Angers | 49033 | France | ||
| Hôpital Pitié-Salpétrière |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38023148 | Derived | Rosinol L, Hebraud B, Oriol A, Colin AL, Rios Tamayo R, Hulin C, Blanchard MJ, Caillot D, Sureda A, Hernandez MT, Arnulf B, Mateos MV, Macro M, San-Miguel J, Belhadj K, Lahuerta JJ, Garelik MB, Blade J, Moreau P. Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma. Front Oncol. 2023 Nov 2;13:1197340. doi: 10.3389/fonc.2023.1197340. eCollection 2023. |
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| Drug |
|
| Velcade® | Drug |
|
| Dexaméthasone | Drug |
|
To evaluate the Safety of induction therapy |
| 15-17 month |
| Number of collected stem cell | 17 month |
| Number of death | To evaluate Overall and Progression-Free Survival | 17 month |
| Response assessment according to the criteria IMWG | compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG) | 15-17 month |
| Number of relapse according to the criteria IMWG | Progression-Free Survival | 17 month |
| 17 month |
| Paris |
| Paris |
| 75651 |
| France |
| Centre Hospitalier de la région d'Annecy | Annecy | Pringy | 74374 | France |
| CHRU Hôpital Sud | Amiens | 80054 | France |
| Centre Hospitalier Argenteuil | Argenteuil | 95 100 | France |
| Centre Hospitalier H.Duffaut | Avignon | 84902 | France |
| Centre Hospitalier de la Côte Basque | Bayonne | 64109 | France |
| CHRU de Besançon | Besançon | 25030 | France |
| Hôpital Avicenne | Bobigny | 93009 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33 300 | France |
| Centre hospitalier Pierre Oudot | Bourgoin | 38300 | France |
| Hôpital A.Morvan | Brest | 29609 | France |
| CHU Caen Côte de Nacre | Caen | 14033 | France |
| CH René Dubos | Cergy-Pontoise | 95303 | France |
| Centre Hospitalier William Morey | Chalon/saone | 71 321 | France |
| Hôpital d'instruction des armées Percy | Clamart | 92141 | France |
| CHU d'Estaing | Clermont-Ferrand | 63000 | France |
| Hôpitaux civils de Colmar | Colmar | 68024 | France |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91100 | France |
| CHU Henri Mondor | Créteil | 94 010 | France |
| CHRU Dijon | Dijon | 21000 | France |
| Centre Hospitalier Général | Dunkirk | 59 385 | France |
| CHRU - Hôpital A.Michallon | Grenoble | 38043 | France |
| Centre hospitalier départemental Vendée | La Roche-sur-Yon | 85925 | France |
| Hôpital Louis Pasteur | Le Coudray | 28000 | France |
| Centre Jean Bernard | Le Mans | 72000 | France |
| CH Le Mans | Le Mans | 72000 | France |
| Hopital Saint Vincent de Paul | Lille | 59020 | France |
| CHRU - Hôpital Claude Huriez | Lille | 59037 | France |
| CHU de Limoges | Limoges | 87042 | France |
| Hôpital Du Scorff | Lorient | 56100 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Centre Hospitalier de Meaux | Meaux | 77104 | France |
| CHR Metz Thionville | Metz | 57085 | France |
| Centre Hospitalier intercommunale Meulan les mureaux | Meulan-en-Yvelines | 78250 | France |
| Hopital E Muller | Mulhouse | 68100 | France |
| Nantes University Hospital | Nantes | 44093 | France |
| Hôpital de l'Archet 1 | Nice | 06202 | France |
| Groupe Hospitalo-Universitaire Carémeau | Nîmes | 30029 | France |
| Institut CURIE | Paris | 75005 | France |
| Hôpital Cochin | Paris | 75014 | France |
| CHU - Hôpital St-Antoine | Paris | 75571 | France |
| Hôpital Pitié-Salpétrière | Paris | 75651 | France |
| AP-HP Hôpital Necker | Paris | 75743 | France |
| CH Saint Jean | Perpignan | 66046 | France |
| CHRU - Hôpital du Haut Lévêque | Pessac | 33604 | France |
| Centre Hospitalier de PERIGUEUX | Périgueux | 24000 | France |
| Centre Hospitalier Lyon sud | Pierre-Bénite | 69495 | France |
| CHRU - Hôpital Jean Bernard | Poitiers | 86021 | France |
| Hôpital R.Debré | Reims | 51092 | France |
| CHRU - Hôpital de Pontchaillou | Rennes | 35033 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Hospitalier Yves le Foll | Saint-Brieuc | 22 027 | France |
| Centre René Huguenin | Saint-Cloud | 92210 | France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | 42 271 | France |
| Centre Hospitalier | Saint-Quentin | 02 321 | France |
| Centre hospitalier | St-Malo | 35400 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| CHRU - Hôpital Purpan | Toulouse | 31059 | France |
| CHRU - Hôpital Bretonneau | Tours | 37044 | France |
| CHRU - Hôpitaux de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| CH Bretagne Atlantique Vannes et Auray | Vannes | 56017 | France |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| D003520 | Cyclophosphamide |
| D000069286 | Bortezomib |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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