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Completed

NCT Number: NCT01274403

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gruppo Italiano Studio Linfoma

Modena, 41120, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melphalan, Prednisone and Thalidomide

Drug

Primary outcomes

  1. To assess the efficacy

    Time frame: from 8 to 12 months

    To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment

  2. To assess the toxicity

    Time frame: From 1 to 12 months

    To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0

Secondary outcomes

  1. To evaluate the Overall Survival (OS) in the 2 arms of treatment

    Time frame: From 1 to 60 months

    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

  2. To evaluate the Duration of Remission (DR) in the 2 arms of treatment

    Time frame: From 8 to 60 months

    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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Studio Linfomi

Other

Registry information

Important dates

First posted
Jan 11, 2011
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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