Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma (PALM)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00794261
First received: November 19, 2008
Last updated: July 7, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.

Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months.

The number of patients required in this multicentric and prospective study is 150 (13 participating centers).

This is a phase II, controlled, randomized, non comparative and open-label multicentric study.


Condition Intervention Phase
Lymphoma
Myeloma
Drug: Injection of Pegfilgrastim
Drug: Injection of Filgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average duration of neutropenia, average duration of thrombocytopenia, number of days with temperature, number of red blood cell units and platelet concentrates transfused to the patient [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Average duration of hospital stay since PSC transplantation [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Number of bacterial and/or viral and/or fungal infections, average duration of antibiotic, antiviral and/or antifungal treatment [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Treatment tolerance [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Evaluation of treatment by Filgrastim [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Evaluation of treatment costs in the two arms [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegfilgrastim
Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
Drug: Injection of Pegfilgrastim
Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
Active Comparator: Filgrastim
Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L)
Drug: Injection of Filgrastim
Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L)

Detailed Description:

High-dose chemotherapy with autologous peripheral stem cell (PSC) transplantation is a standard consolidation treatment for the initial management of patients with myeloma treated with high-dose Melphalan, or patients with certain lymphomas or with chemosensitive relapses of Hodgkin's lymphoma (HL) or malignant non Hodgkin's lymphoma (MNHL). This procedure is associated with prolonged neutropenia and considerable morbidity. Many randomized trials have tested post-graft administration of granulocyte growth factors (granulocyte colony stimulating Factor: G-CSF) or granulocyte-monocyte growth factors (granulocyte macrophage colony stimulating Factor: GM-CSF). All have shown a reduction of neutropenia and shorter hospital stays on G-CSF or GM-CSF treatment. Different guidelines have recommended the use of growth factors after autologous stem cell transplantation. The effectiveness of growth factor treatment would be identical, whether given immediately after PSC transplantation or delayed until D5 or D7.

Pegfilgrastim is a growth factor resulting from the modification of Filgrastim by addition of a polyethylene glycol (PEG) moiety, which increases its half-life by decreasing its renal clearance. Thus, one injection is equivalent to several Filgrastim injections. Studies of Pegfilgrastim or Filgrastim efficacy on the duration of chemotherapy-induced neutropenia in patients with breast cancer or with non-small cell lung cancer or LMNH have produced equivalent results.

In haematology, Pegfilgrastim has been used for PSC mobilization. Six studies evaluating the efficacy of Pegfilgrastim compared to other G-CSF after autologous hematopoietic PSC transplantation in patients with myeloma and lymphomas have shown equivalent results. A superiority of Pegfilgrastim over other G-CSF has even been reported (though in only one randomized small-scale study).

A randomized phase II study evaluating Pegfilgrastim efficacy and tolerance in lymphoma or myeloma patients receiving PSC transplantation appears necessary to confirm or refute the potential clinical interest of the drug.

On the day of autologous PSC transplantation (D0) the patients will be randomly assigned to receive one or the other treatment strategy.

NB: Patients will receive support care, antibiotic treatments and transfusion procedures specific to each participating centre.

They will be followed-up according to recommendations for the management of this type of patients. No additional examination is planned.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged ≥ 18 years
  • Patients with histologically confirmed lymphoma or myeloma
  • Treatment with high-dose chemotherapy before inclusion

    • Intensification with high dose Melphalan for patients with myeloma
    • Whatever the conditioning regimen, except TBI for patients with 1st relapse of Hodgkin's lymphoma or with MNHL NB: Patients having received two intensification courses are eligible if there has been more than 100 days between courses.
  • Autologous PSC transplantation at the time of inclusion
  • Reinjection of ≥ 2.106 CD34/kg
  • Patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (PNN > 0.5 G/L)
  • Mandatory affiliation with a health insurance system
  • Patients able to understand, read and write French
  • Signed, written informed consent

Exclusion Criteria:

  • TBI during conditioning
  • Severe intolerance to the growth factor under study, or hypersensitivity to one of their components
  • Immunosuppressive syndrome
  • Pregnant or lactating women
  • Difficult follow-up
  • Documented history of cognitive or psychiatric disorders
  • Participation or consideration of participation in another biomedical study during the follow-up period of the present trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794261

Locations
France
CHU Angers
Angers, France, 49000
CHU Brest
Brest, France, 29609
Centre Leon Berard
Lyon, France, 69008
Hopital Edouard Herriot
Lyon, France, 69008
Hôpital Lapeyronnie
Montpellier, France, 34295
CHU Nantes
Nantes, France, 44000
Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69495
Centre Henri Becquerel
Rouen, France, 76038
CHU Toulouse - Hôpital Purpam
Toulouse, France, 31000
CHU Tours - Hôpital Bretonneau
Tours, France, 37000
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Leon Berard
Amgen
Investigators
Principal Investigator: Catherine SEBBAN, MD Centre Léon Bérard, LYON
  More Information

No publications provided

Responsible Party: Zora ABDELBOST, Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE
ClinicalTrials.gov Identifier: NCT00794261     History of Changes
Other Study ID Numbers: PALM, ET2007 - 113
Study First Received: November 19, 2008
Last Updated: July 7, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Myeloma
lymphoma
high-dose chemotherapy
PSC infusion, autologous
neutropenia
thrombocytopenia
hospital stay
infection
Autologous PSC transplantation for patients with lymphoma or myeloma treated with high-dose chemotherapy

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014