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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671826
First Posted: August 24, 2012
Last Update Posted: June 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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 ]

Secondary Outcome Measures:
  • Response [ Time Frame: after induction, 3 months post transplant, 2 months post consolidation ]
  • Time To Progression [ Time Frame: 2 years ]
  • Overall Survival [ Time Frame: 2 years ]

Enrollment: 55
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671826


Locations
France
CHU
Dijon, France
CHU
Lille, France
CHU
Lyon, France
Institut Paoli Calmette
Marseille, France
CHU
Nantes, France
Hôpital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent Garderet, MD Assistance Publique
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01671826     History of Changes
Other Study ID Numbers: LGT-2012
First Submitted: August 21, 2012
First Posted: August 24, 2012
Last Update Posted: June 24, 2016
Last Verified: June 2016

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