A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT01274403
First received: December 28, 2010
Last updated: January 10, 2011
Last verified: December 2010
  Purpose

The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.


Condition Intervention Phase
Multiple Myeloma
Drug: Melphalan, Prednisone and Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • To assess the efficacy [ Time Frame: from 8 to 12 months ] [ Designated as safety issue: No ]
    To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment

  • To assess the toxicity [ Time Frame: From 1 to 12 months ] [ Designated as safety issue: Yes ]
    To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0


Secondary Outcome Measures:
  • To evaluate the Overall Survival (OS) in the 2 arms of treatment [ Time Frame: From 1 to 60 months ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause

  • To evaluate the Duration of Remission (DR) in the 2 arms of treatment [ Time Frame: From 8 to 60 months ] [ Designated as safety issue: No ]
    DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination


Enrollment: 130
Arms Assigned Interventions
Experimental: Melphalan, prednisone plus Thalidomide Drug: Melphalan, Prednisone and Thalidomide
Active Comparator: Melphalan and Prednisone Drug: Melphalan, Prednisone and Thalidomide

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed of multiple myeloma.
  • Age > 65 years
  • ECOG <= 3
  • Written informed consent given at the time of randomization
  • Patients with age <= 65 but not eligible for high dose treatment with stem cells support

Exclusion Criteria:

  • ECOG > 3
  • current neoplasm..
  • contraindications to use thalidomide
  • peripheral neurophaty
  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: NCT01274403

Locations
Italy
Gruppo Italiano Studio Linfoma
Modena, Italy, 41120
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
  More Information

No publications provided

Responsible Party: Gruppo Italiano Studio Linfoma, GISL
ClinicalTrials.gov Identifier: NCT01274403     History of Changes
Other Study ID Numbers: MM03
Study First Received: December 28, 2010
Last Updated: January 10, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Studio Linfomi:
Multiple Myeloma
Elderly patients

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
Melphalan
Thalidomide
Prednisone
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014