Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years (LATMM)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Newly Diagnosed Myeloma Patient Above 65 Years Old

Study type: Observational

Funder types: Other

Identifiers

NCT01671826

LGT-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed MM,
• age over 65,
• measurable disease

Exclusion criteria

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

Trial design

55 participants in 1 patient group

above 65 years old