Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years

Newly Diagnosed Myeloma Patient Above 65 Years Old Clinical Trial

— LATMM  

Official title:

Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01671826
• Other study ID #: LGT-2012
• Status: Active, not recruiting
• Phase: N/A
• First received: August 21, 2012
• Last updated: June 23, 2016
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.

Description:

Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• newly diagnosed MM,

• age over 65,

• measurable disease

Exclusion Criteria:

• Patients less than 65 and/or not proceeding to autologous PBSC transplantation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Myeloma Patient Above 65 Years Old

Locations

Country	Name	City	State
France	CHU	Dijon
France	CHU	Lille
France	CHU	Lyon
France	Institut Paoli Calmette	Marseille
France	CHU	Nantes
France	Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free survival		2 years	Yes
Secondary	Response		after induction, 3 months post transplant, 2 months post consolidation	Yes
Secondary	Time To Progression		2 years	No
Secondary	Overall Survival		2 years	Yes