Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years

NCT ID: NCT01671826

Last Updated: 2016-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Newly Diagnosed Myeloma Patient Above 65 Years Old

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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above 65 years old

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Garderet, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Locations

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CHU

Dijon, , France

Site Status

CHU

Lille, , France

Site Status

CHU

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

CHU

Nantes, , France

Site Status

Hôpital Saint Antoine

Paris, , France

Site Status

Countries

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France

References

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Garderet L, Beohou E, Caillot D, Stoppa AM, Touzeau C, Chretien ML, Karlin L, Moreau P, Fontan J, Blaise D, Polge E, Gueye MS, Ikhlef S, Marjanovic Z, Labopin M, Mohty M. Upfront autologous stem cell transplantation for newly diagnosed elderly multiple myeloma patients: a prospective multicenter study. Haematologica. 2016 Nov;101(11):1390-1397. doi: 10.3324/haematol.2016.150334. Epub 2016 Sep 9.

Reference Type DERIVED
PMID: 27612987 (View on PubMed)

Other Identifiers

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LGT-2012

Identifier Type: -

Identifier Source: org_study_id

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