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Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma


Phase 3
75 Years
N/A
Not Enrolling
Both
Newly Diagnosed, Multiple Myeloma

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Trial Information

Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma


Inclusion Criteria:



- Stage II or III multiple myeloma according to Durie and Salmon criteria, patients
older than 75 years, previously untreated patients.

Exclusion Criteria:

- Prior history of another neoplasm (except basocellular cutaneous or cervical
epithelioma)

- Primary or associated amyloïdosis

- 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 clinically significant

- History of venous thrombosis during the last 6 months

- HIV or hepatitis B or C positivity

- Patients who had geography, social, or psychological conditions which might prevent
adequate follow-up.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

overall Survival

Outcome Time Frame:

May 2007

Safety Issue:

Yes

Principal Investigator

Cyrille Hulin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)

Authority:

France: French Agency of Health Security and Drugs Products

Study ID:

University Hospital, Nancy

NCT ID:

NCT00644306

Start Date:

April 2002

Completion Date:

May 2007

Related Keywords:

  • Newly Diagnosed, Multiple Myeloma
  • Multiple Myeloma, very elderly patients, thalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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