Multiple Myeloma Clinical Trial
Official title:
Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years
| Verified date | May 2017 |
| Source | University Hospital, Toulouse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | July 2011 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 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 - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service of Blood Deseases - South Hospital | Amiens | |
| France | Service of Clinical Hematology - Bocage Hospital | Angers | |
| France | Service of Clinical Hematology - Cote Basque Hospital | Bayonne | |
| France | Service of Clinical Hematology - Minjoz Hospital | Besançon | |
| France | Service of Clinical Hematology - Avicenne Hospital | Bobigny | |
| France | Service of Clinical Hematology - A. Morvan Hospital | Brest | |
| France | Service of Clinical Hematology - F. Baclesse Center | Caen | |
| France | Service of Clinical Hematology - Army Instruction Hospital of Percy | Clamart | |
| France | Service of Clinical Hematology - UH of Clermont-Ferrand | Clermont-Ferrand | |
| France | Service of Oncohematology - Louis Pasteur Hospital | Colmar | |
| France | Service of Hematology - Bocage Hospital | Dijon | |
| France | Service of Hematology - General Hospital | Dunkerque | |
| France | Service of Hematology - A. Michallon Hospital | Grenoble | |
| France | Service of Hematology - Claude Hurriez Hospital | Lille | |
| France | Service of Hematology - Edouard Herriot Hospital | Lyon | |
| France | Service of Hematology - Léon Bérard Center | Lyon | |
| France | Service of Hematology - Lyon Sud Hospital | Lyon | |
| France | Service of Hematology - Paoli Calmette Institute | Marseille | |
| France | Service of Hematology - Notre Dame du Bon Secours Hospital | Metz | |
| France | Service of Blood Deseases - UH of Nantes | Nantes | |
| France | Service of Clinical Hematology - Archet 1 Hospital | Nice | |
| France | Service of Oncology - Archet 1 Hospital | Nice | |
| France | Service of Blood Deseases - Saint Antoine Hospital | Paris | |
| France | Service of Hematology - Cochin Hospital | Paris | |
| France | Service of Hematology - Hotel Dieu | Paris | |
| France | Service of Hematology - Jean Bernard Hospital | Poitiers | |
| France | Service of Hematology - R.Debré Hospital | Reims | |
| France | Service of Hematology - Pontchaillou Hospital | Rennes | |
| France | Service of Hematology -Henri Becquerel Center | Rouen | |
| France | Service of Hematology - Hautepierre Hospital | Strasbourg | |
| France | Service of Clinical Hematology - Purpan hospital TSA 40031 | Toulouse | |
| France | Service of Onco-Hematology - Bretonneau Hospital | Tours | |
| France | Service of Hematology - Brabois Hospital | Vandoeuvre | |
| France | Service of Hematology -Gustave Roussy Institute | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Toulouse | Intergroupe Francophone du Myelome |
France,
Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pégourié 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; Intergro — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the Complete Response and Very Good Partial Response (VGPR) rates 3 months after autologous blood stem cell transplantation conditioned by Velcade-Melphalan | 3 months after autologous stem cell transplantation | ||
| Secondary | 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 | 3 months |
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