Know Cancer

or
forgot password

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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

3 months after autologous stem cell transplantation

Safety Issue:

Yes

Principal Investigator

Murielle ROUSSEL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Purpan Hospital - UH Toulouse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0603603

NCT ID:

NCT00642395

Start Date:

July 2007

Completion Date:

July 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Autologous Stem Cells Transplantation
  • High Dose Melphalan
  • Bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location