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Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)

Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Bortezomib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Hospital, Toulouse

Official(s) and/or principal investigator(s):
Murielle ROUSSEL, MD, Principal Investigator, Affiliation: Purpan Hospital - UH Toulouse

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). 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.

Clinical Details

Official title: Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Service of Blood Deseases - South Hospital, Amiens 80054, France

Service of Clinical Hematology - Bocage Hospital, Angers 49033, France

Service of Clinical Hematology - Cote Basque Hospital, Bayonne 64109, France

Service of Clinical Hematology - Minjoz Hospital, Besançon 25030, France

Service of Clinical Hematology - Avicenne Hospital, Bobigny 93009, France

Service of Clinical Hematology - A. Morvan Hospital, Brest 29609, France

Service of Clinical Hematology - F. Baclesse Center, Caen 14076, France

Service of Clinical Hematology - Army Instruction Hospital of Percy, Clamart 92141, France

Service of Clinical Hematology - UH of Clermont-Ferrand, Clermont-Ferrand 63003, France

Service of Oncohematology - Louis Pasteur Hospital, Colmar 68024, France

Service of Hematology - Bocage Hospital, Dijon 21034, France

Service of Hematology - General Hospital, Dunkerque 59385, France

Service of Hematology - A. Michallon Hospital, Grenoble 38043, France

Service of Hematology - Claude Hurriez Hospital, Lille 59037, France

Service of Hematology - Edouard Herriot Hospital, Lyon 69437, France

Service of Hematology - Lyon Sud Hospital, Lyon 69495, France

Service of Hematology - Léon Bérard Center, Lyon 69008, France

Service of Hematology - Paoli Calmette Institute, Marseille 13273, France

Service of Hematology - Notre Dame du Bon Secours Hospital, Metz 57038, France

Service of Blood Deseases - UH of Nantes, Nantes 44035, France

Service of Clinical Hematology - Archet 1 Hospital, Nice 06202, France

Service of Oncology - Archet 1 Hospital, Nice 06202, France

Service of Blood Deseases - Saint Antoine Hospital, Paris 75571, France

Service of Hematology - Cochin Hospital, Paris 75014, France

Service of Hematology - Hotel Dieu, Paris 75004, France

Service of Hematology - Jean Bernard Hospital, Poitiers 86021, France

Service of Hematology - R.Debré Hospital, Reims 51032, France

Service of Hematology - Pontchaillou Hospital, Rennes 35033, France

Service of Hematology -Henri Becquerel Center, Rouen 76038, France

Service of Hematology - Hautepierre Hospital, Strasbourg 67098, France

Service of Clinical Hematology - Purpan hospital TSA 40031, Toulouse 31059, France

Service of Onco-Hematology - Bretonneau Hospital, Tours 37044, France

Service of Hematology - Brabois Hospital, Vandoeuvre 54511, France

Service of Hematology -Gustave Roussy Institute, Villejuif 94805, France

Additional Information

Starting date: July 2007
Last updated: October 10, 2011

Page last updated: August 23, 2015

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