Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years (LATMM)
This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01671826
First received: August 21, 2012
Last updated: November 16, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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: | November 16, 2012 |
| 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 June 17, 2013