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

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ClinicalTrials.gov Identifier: NCT01274403
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : January 11, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan, Prednisone and Thalidomide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Masking: None (Open Label)

Arms and Interventions

Arm Intervention/treatment
Experimental: Melphalan, prednisone plus Thalidomide Drug: Melphalan, Prednisone and Thalidomide
Active Comparator: Melphalan and Prednisone Drug: Melphalan, Prednisone and Thalidomide

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274403

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

Responsible Party: Gruppo Italiano Studio Linfoma, GISL
ClinicalTrials.gov Identifier: NCT01274403     History of Changes
Other Study ID Numbers: MM03
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: December 2010

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors