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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907452
Recruitment Status : Unknown
Verified June 2011 by Intergroupe Francophone du Myelome.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2009
Last Update Posted : June 21, 2011
Information provided by:
Intergroupe Francophone du Myelome

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Myeloma Drug: melphalan-prednisone-thalidomide Drug: lenalidomide-dexamethasone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : April 2009
Estimated Primary Completion Date : September 2011

Arm Intervention/treatment
Active Comparator: melphalan-prednisone-thalidomide Drug: melphalan-prednisone-thalidomide
Active Comparator: lenalidomide-dexamethasone Drug: lenalidomide-dexamethasone

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907452

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Albi, France
CHRU Angers
Angers, France
CH Côte basque
Bayonne, France
CH Blois
Blois, France
Bordeaux, France
Chalons sur Saone
Chalons sur Saone, France
CHU Dijon
Dijon, France
Ch Dunkerque
Dunkerque, France
Chu Grenoble
Grenoble, France
CHD Vendée
La Roche Sur Yon, France
CHRU Lille
Lille, France
Lyon, France
Lyon, France
Ipc Marseille
Marseille, France
Metz, France
CH Mulhouse
Mulhouse, France
Chu Nancy
Nancy, France
Chu Nantes
Nantes, France
Centre Antoine LACASSAGNE
Nice, France
Institut Curie
Paris, France
Chu Poitiers
Poitiers, France
Chu Rennes
Rennes, France
CH Yves Le Foll
St Brieuc, France
René Huguenin
St CLOUD, France
Chu Toulouse
Toulouse, France
Chu Tours
Tours, France
Sponsors and Collaborators
Intergroupe Francophone du Myelome
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Study Chair: Philippe MOREAU, Pr Departement of clinical Hematology (University Hospital of Nantes)

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Responsible Party: Principal investigator: AVET-LOISEAU Hervé, University Hospital, Nantes Identifier: NCT00907452     History of Changes
Other Study ID Numbers: IFM 2007-03
Eudract: 2008-003486-58
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: June 2011

Keywords provided by Intergroupe Francophone du Myelome:
prediction response
prediction adverse event

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists