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

NCT ID: NCT01274403

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

NONE

Study Groups

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Melphalan, prednisone plus Thalidomide

Group Type EXPERIMENTAL

Melphalan, Prednisone and Thalidomide

Intervention Type DRUG

Melphalan and Prednisone

Group Type ACTIVE_COMPARATOR

Melphalan, Prednisone and Thalidomide

Intervention Type DRUG

Interventions

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Melphalan, Prednisone and Thalidomide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role lead

Responsible Party

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GISL

Locations

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Gruppo Italiano Studio Linfoma

Modena, Modena, Italy

Site Status

Countries

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Italy

Other Identifiers

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MM03

Identifier Type: -

Identifier Source: org_study_id

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