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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01671826
First received: August 21, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition
Newly Diagnosed Myeloma Patient Above 65 Years Old

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Progression Free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response [ Time Frame: after induction, 3 months post transplant, 2 months post consolidation ] [ Designated as safety issue: Yes ]
  • Time To Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
above 65 years old

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed myeloma patients over 65 years of age and a measurable disease.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients less than 65 and/or not proceeding to autologous PBSC transplantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671826

Contacts
Contact: Laurent Garderet, MD + 33 1 49 28 26 18 laurent.garderet@sat.aphp.fr
Contact: souhila Ikhlef, MD + 33 1 49 28 28 43 souhila.ikhlef@sat.aphp.fr

Locations
France
CHU Recruiting
Dijon, France
Principal Investigator: Denis Caillot, MD         
CHU Recruiting
Lille, France
Principal Investigator: Ibrahim Yakoub-Agha, MD         
CHU Recruiting
Lyon, France
Principal Investigator: Karlin, Doctor         
Institut Paoli Calmette Recruiting
Marseille, France
Principal Investigator: Anne marie Stoppa, MD         
Sub-Investigator: Didier Blaise, MD         
CHU Recruiting
Nantes, France
Principal Investigator: Moreau, Professor         
Sub-Investigator: Touzeau, Touzeau         
Hôpital Saint Antoine Recruiting
Paris, France, 75012
Contact: Laurent Garderet, MD    + 33 1 49 28 26 18    laurent.garderet@sat.aphp.fr   
Contact: souhila ikhlef, MD    + 33 1 49 28 28 43    souhila.ikhlef@sat.aphp.fr   
Principal Investigator: Laurent Garderet, MD         
Sub-Investigator: Mohamad Mohty, MD         
Sub-Investigator: Ollivier Legrand, MD         
Sub-Investigator: Paul Coppo, MD         
Sub-Investigator: Jean Pierre Marie, MD         
Sub-Investigator: Francoise Isnard, MD         
Sub-Investigator: Zora Marjanovic, MD         
Sub-Investigator: Malek Aoudjhane, MD         
Sub-Investigator: Anne Vekhoff, MD         
Sub-Investigator: Jan Voswinkel, MD         
Sub-Investigator: Marie therese Rubio, MD         
Sub-Investigator: Simona Lapusan, MD         
Sub-Investigator: Marc Buffet, MD         
Sub-Investigator: Marie Paule Lemonier, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent Garderet, MD Assistance Publique
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01671826     History of Changes
Other Study ID Numbers: LGT-2012
Study First Received: August 21, 2012
Last Updated: February 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multiple Myeloma
Autologous Stem Cell Transplantation
Elderly Patients

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014