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)

This study has been terminated.
(survival advantage demonstrated)
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00644306
First received: March 20, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Newly Diagnosed, Multiple Myeloma
Drug: Thalidomide
Drug: melphalan, prednisone
Drug: melphalan, prednisone, thalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • overall Survival [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • Response rates [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 232
Study Start Date: April 2002
Study Completion Date: May 2007
Arms Assigned Interventions
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 Name: 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 Name: Alkeran, cortancyl

  Eligibility

Ages Eligible for Study:   75 Years and older
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644306

Locations
France
CHU Nancy - Brabois, rue du morvan
Vandoeuvre, France, 54511
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Cyrille Hulin, MD Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
  More Information

Publications:
Responsible Party: Hulin Cyrille, Intergroupe Francophone du Myélome (IFM)
ClinicalTrials.gov Identifier: NCT00644306     History of Changes
Other Study ID Numbers: University Hospital, Nancy
Study First Received: March 20, 2008
Last Updated: March 20, 2008
Health Authority: France: French Agency of Health Security and Drugs Products

Keywords provided by Central Hospital, Nancy, France:
Multiple Myeloma, very elderly patients, thalidomide

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
Melphalan
Prednisone
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 September 30, 2014