Pethema Multiple Myeloma 2000

November 26, 2008 updated by: PETHEMA Foundation

Multiple Myeloma 2000. Multicentric Evaluation of a Therapeutic Strategy Optimized in Multiple Myeloma. Analysis of Efficiency and Possible Pronostic Impact of Minimal Residual Disease (Measured By PCR And Citometry of Flow) in Patients With Complete Response

The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Less 70 years
  • ECOG 0-2
  • Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl).
  • No previous chemotherapy

Exclusion Criteria:

  • >70 years
  • ECOG 3-4
  • myeloma quiescent
  • cardiopathy
  • liver disfunction
  • HIV+
  • Hepatitis B-C +
  • Previous chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Joan Bladé, Dr, Hospital Clinic of Barcelona
  • Study Chair: Juan Jose Lahuerta, Dr, Hospital Doce de Octubre Madrid
  • Study Chair: Adrián Alegre, Dr, Hospital La Princesa (Madrid)
  • Study Chair: Anna Sureda, Dr, Hospital Sant Pau Barcelona
  • Study Chair: Joaquín Díaz Mediavilla, Dr, Hospital Clinico Madrid
  • Study Chair: Javier De la Rubia, Dr, Hospital La Fe de Valencia
  • Study Chair: Joan Bargay, Dr, Hospital Son Dureta Palma de Mallorca
  • Study Chair: Jose García-Laraña, Dr, Hospital Universitario Ramón y Cajal
  • Study Chair: Eulogio Conde, Dr, Hospital Valdecilla Santander
  • Study Chair: Felipe Prosper, Dr, Hospital Clinico Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2008

Last Update Submitted That Met QC Criteria

November 26, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETHEMA MM-2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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