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

This study has been completed.
Sponsor:
Collaborator:
Intergroupe Francophone du Myelome
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00642395
First received: March 13, 2008
Last updated: October 10, 2011
Last verified: October 2011

March 13, 2008
October 10, 2011
July 2007
October 2008   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00642395 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)
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.

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Bortezomib
bortezomib-Melphalan
Other Name: Velcade
Experimental: 1
bortézomib
Intervention: Drug: Bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
July 2011
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00642395
0603603
No
University Hospital, Toulouse
University Hospital, Toulouse
Intergroupe Francophone du Myelome
Principal Investigator: Murielle ROUSSEL, MD Purpan Hospital - UH Toulouse
University Hospital, Toulouse
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP