Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Intergroupe Francophone du Myelome.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Intergroupe Francophone du Myelome
ClinicalTrials.gov Identifier:
NCT00907452
First received: May 20, 2009
Last updated: June 18, 2011
Last verified: June 2011

May 20, 2009
June 18, 2011
April 2009
September 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00907452 on ClinicalTrials.gov Archive Site
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Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma.

To this end, the study seeks to predict the following parameters in these patients:

  • The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination.
  • Progression-free survival and overall survival.

Prediction of the treatment response and the occurrence of adverse effects will be based on:

  • An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations.
  • An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression).

Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Myeloma
  • Drug: melphalan-prednisone-thalidomide
  • Drug: lenalidomide-dexamethasone
  • Active Comparator: melphalan-prednisone-thalidomide
    Intervention: Drug: melphalan-prednisone-thalidomide
  • Active Comparator: lenalidomide-dexamethasone
    Intervention: Drug: lenalidomide-dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1555
Not Provided
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form
  • Age ≥ 65 years at the time of signing consent
  • Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required)

    • Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
    • Monoclonal protein present in the serum and/or urine
    • Myeloma-related organ dysfunction (at least one of the following):

      • Calcium elevation in the blood (serum calcium > 10.5 mg/l or upper limit of normal)
      • Renal insufficiency (serum creatinine > 2 mg/dl)
      • Anemia (hemoglobin < 10 g/dl or 2 g < normal)
      • Lytic bone lesions or osteoporosis
  • have measurable disease by protein electrophoresis analyses as defined by the following:

    • IgG multiple myeloma: Serum monoclonal paraprotein (M-protein)level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 h
    • IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level³ 200 mg/24 h
    • IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dL or urine Mprotein level ≥ 200 mg/24h
    • IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dL or urine M-protein level ≥ 200 mg/24h
    • Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dL or urine Mprotein level ≥ 200 mg/24 hours
  • ECOG performance status of 0, 1, or 2
  • Treated by either melphalan-prednisone-thalidomide or lenalidomide- dexamethasone

Exclusion Criteria:

  • Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of randomization]
  • Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study
  • Any of the following laboratory abnormalities :

    • Absolute neutrophil count (ANC) < 1,000 cells/µL (1.0 x 109/L)
    • Platelet count < 50,000 cells/µL (50 x 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count < 30,000/µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
    • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
    • Creatinine clearance ≤ 30 mL/min (Cockroft-Gault calculation)
  • Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
  • Patients who have are unable or unwilling to undergo antithrombotic therapy
  • Peripheral neuropathy of > grade 2 severity
  • Known HIV positivity or active infectious hepatitis, type A, B, or C.
  • Primary AL amyloidosis and myeloma complicated by amyloidosis.
  • Renal failure requiring dialysis
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00907452
IFM 2007-03, Eudract: 2008-003486-58
No
Principal investigator: AVET-LOISEAU Hervé, University Hospital, Nantes
Intergroupe Francophone du Myelome
Not Provided
Study Chair: Philippe MOREAU, Pr Departement of clinical Hematology (University Hospital of Nantes)
Intergroupe Francophone du Myelome
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP