Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma (IFM 01/01)

March 20, 2008 updated by: Central Hospital, Nancy, France
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 3

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
      • Vandoeuvre, France, 54511
        • CHU Nancy - Brabois, rue du morvan

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
Drug: Thalidomide
100 mg/day continuously for 18 months
Drug: melphalan, prednisone
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
Other Names:
  • Alkeran, cortancyl
Active Comparator: B
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
Drug: melphalan, prednisone, thalidomide
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
Other Names:
  • Alkeran, cortancyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall Survival
Time Frame: May 2007
May 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: May 2007
May 2007
Response rates
Time Frame: May 2007
May 2007
Safety
Time Frame: May 2007
May 2007

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Cyrille Hulin, MD, Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)

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

April 1, 2002

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 26, 2008

Last Update Submitted That Met QC Criteria

March 20, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University Hospital, Nancy

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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