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

August 4, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets
  2. Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned
  3. Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • CHU Haut-Leveque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
autologous peripheral blood stem cell transplantation
Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified
autologous peripheral blood stem cell transplantation, ex vivo amplified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft

Secondary Outcome Measures

Outcome Measure
Time Frame
Immediate Toxicity of the injection of the amplified graft ;
Time Frame: just after the injection of the amplified graft
just after the injection of the amplified graft
Quantitative immunological Reconstitution
Time Frame: at day 30, 100, 180, 270, 360 after the injection and then every 6 months
at day 30, 100, 180, 270, 360 after the injection and then every 6 months
Stability of the hematopoiesis in the long term
Time Frame: at 1, 3, 6, 9 and 12 months after the graft
at 1, 3, 6, 9 and 12 months after the graft
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
at 1, 3, 6, 9 and 12 months after the injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Noel MILPIED, MS, MD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimated)

April 18, 2007

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2000/04
  • TC6A10A11A12 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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