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

March 29, 2021 updated by: Intergroupe Francophone du Myelome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

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
      • Albi, France
        • CH Albi
      • Angers, France
        • CHRU Angers
      • Bayonne, France
        • CH Cote Basque
      • Blois, France
        • CH BLOIS
      • Bordeaux, France
        • Bordeaux
      • Chalon-sur-Saône, France
        • Chalon sur Saone
      • Dijon, France
        • CHU Dijon
      • Dunkerque, France
        • Ch Dunkerque
      • Grenoble, France
        • CHU Grenoble
      • La Roche Sur Yon, France
        • CHD Vendee
      • Lille, France
        • CHRU Lille
      • Lyon, France
        • CHU LYON
      • Lyon, France
        • Lyon Sud
      • Marseille, France
        • IPC Marseille
      • Metz, France
        • CHR Metz
      • Mulhouse, France
        • CH Mulhouse
      • Nancy, France
        • Chu Nancy
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Institut Curie
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • CHU Rennes
      • St Brieuc, France
        • CH Yves Le Foll
      • St CLOUD, France
        • René Huguenin
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • Chu Tours

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: melphalan-prednisone-thalidomide
Drug: melphalan-prednisone-thalidomide
Active Comparator: lenalidomide-dexamethasone
Drug: lenalidomide-dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
best response to treatment
Time Frame: 1 year
best response rate
1 year

Collaborators and Investigators

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

Sponsor

Intergroupe Francophone du Myelome

Investigators

  • Study Chair: Philippe MOREAU, Pr, Departement of clinical Hematology (University Hospital of Nantes)

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 (Actual)

July 29, 2009

Primary Completion (Actual)

December 14, 2010

Study Completion (Actual)

July 14, 2016

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 21, 2009

First Posted (Estimate)

May 22, 2009

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFM 2007-03
  • Eudract: 2008-003486-58

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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