Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00367185
First received: August 21, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Best response rate
  • Progression-free survival
  • Survival after progression
  • Toxicity

Estimated Enrollment: 500
Study Start Date: May 2000
Estimated Study Completion Date: October 2005
Detailed Description:

Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage II or III multiple myeloma according to Durie and Salmon criteria.
  • Patients between 65 and 75 years of age
  • Previously untreated patients

Exclusion Criteria:

  • Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
  • Primary or associated amyloidosis
  • World Health organisation performance index of at least 3
  • Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
  • Cardiac or hepatic dysfunction
  • Cerebral circulatory insufficiency
  • Absolute contraindication to corticosteroids
  • Peripheral neuropathy
  • HIV or hepatitis B or C positivity
  • Patients who had geographic, social or psychological conditions which might prevent adequate follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367185

Locations
France
Lille University Hospital
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Director: Jean-Yves MARY U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France
  More Information

No publications provided by University Hospital, Lille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00367185     History of Changes
Other Study ID Numbers: IFM 99-06
Study First Received: August 21, 2006
Last Updated: August 21, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
Multiple myeloma
Elderly patients
Thalidomide
Autologous transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 14, 2014