Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

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: NCT00367185
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : August 22, 2006
Information provided by:
University Hospital, Lille

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2000
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Best response rate
  2. Progression-free survival
  3. Survival after progression
  4. Toxicity

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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00367185

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00367185     History of Changes
Other Study ID Numbers: IFM 99-06
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: August 22, 2006
Last Verified: April 2006

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

Additional relevant MeSH terms:
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents