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Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation (Expansion)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
autologous peripheral blood stem cell transplantation, ex vivo amplified
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Symptomatic Multiple Myeloma, first line treatment, first autologous Stem Cell Transplantation, ex vivo amplified autologous peripheral blood stem cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient between 18 and 65 years of age
  • Diagnosis of Multiple Myeloma, requiring a treatment, including high dose Melphalan whith autologous peripheral blood stem cell transplantation
  • Performance status: < 2 (Karnofsky > 70%)
  • Anticipated survival > 3 month
  • Collection of a minimum of 10x106 cells (CD34+)/Kg of autologous G-CSF mobilised peripheral blood stem cells in 2 to 3 pheresis.
  • Signed and dated informed consent

Exclusion Criteria:

  • Multiple Myeloma not requiring a treatment
  • Another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
  • Positive serology for HIV, hepatitis C or hepatitis B
  • Hepato cellular insufficiency
  • Severe renal insufficiency defined by a creatine clearance < 30 ml/mn
  • Women pregnant or nursing, or effective absence of contraception
  • Antecedent of serious cardiac disease in the last 6 months.
  • Allergy known to the products derived from Escherichia Coli

Sites / Locations

  • CHU Haut-Leveque

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

autologous peripheral blood stem cell transplantation

Outcomes

Primary Outcome Measures

Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.

Secondary Outcome Measures

Immediate Toxicity of the injection of the amplified graft ;
Quantitative immunological Reconstitution
Stability of the hematopoiesis in the long term
Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term.

Full Information

First Posted
April 17, 2007
Last Updated
November 3, 2010
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00461955
Brief Title
Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation
Acronym
Expansion
Official Title
Pilot Clinical Trial of Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation in Adult Patients With Multiple Myeloma in First Response
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion.
Detailed Description
To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain a hematopoietic reconstitution: Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Symptomatic Multiple Myeloma, first line treatment, first autologous Stem Cell Transplantation, ex vivo amplified autologous peripheral blood stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
autologous peripheral blood stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
autologous peripheral blood stem cell transplantation, ex vivo amplified
Intervention Description
autologous peripheral blood stem cell transplantation, ex vivo amplified
Primary Outcome Measure Information:
Title
Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.
Time Frame
at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft
Secondary Outcome Measure Information:
Title
Immediate Toxicity of the injection of the amplified graft ;
Time Frame
just after the injection of the amplified graft
Title
Quantitative immunological Reconstitution
Time Frame
at day 30, 100, 180, 270, 360 after the injection and then every 6 months
Title
Stability of the hematopoiesis in the long term
Time Frame
at 1, 3, 6, 9 and 12 months after the graft
Title
Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term.
Time Frame
at 1, 3, 6, 9 and 12 months after the injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient between 18 and 65 years of age Diagnosis of Multiple Myeloma, requiring a treatment, including high dose Melphalan whith autologous peripheral blood stem cell transplantation Performance status: < 2 (Karnofsky > 70%) Anticipated survival > 3 month Collection of a minimum of 10x106 cells (CD34+)/Kg of autologous G-CSF mobilised peripheral blood stem cells in 2 to 3 pheresis. Signed and dated informed consent Exclusion Criteria: Multiple Myeloma not requiring a treatment Another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection Positive serology for HIV, hepatitis C or hepatitis B Hepato cellular insufficiency Severe renal insufficiency defined by a creatine clearance < 30 ml/mn Women pregnant or nursing, or effective absence of contraception Antecedent of serious cardiac disease in the last 6 months. Allergy known to the products derived from Escherichia Coli
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel MILPIED, MS, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Citations:
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Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation

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