GEM05 for Patients With Multiple Myeloma More Than 65 Years Old

September 16, 2011 updated by: PETHEMA Foundation

A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old.

The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of up to 260 patients > 65 years old diagnosed of Multiple Myeloma with symptomatic disease and that have not received previous chemotherapy for MM will be included.

Patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.

The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility and then Patients will be randomized one to one to receive Melphalan+Prednisone+Velcade (Group A) or Thalidomide+Prednisone+Velcade (Group B). All of them will received the induction treatment up to 30 weeks. After 4 weeks, without progression and unacceptable toxicity, Patients will be again randomized one to one to receive maintenance treatment: Thalidomide+Velcade (Group M1) or Prednisone+Velcade (Group M2) during three years.

Once the treatment period has finished a follow up will be carry out. During this period we will evaluated response, progression-free survival and global survival every three months.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain
        • Complejo Hospitalario Universitario de Albacete
      • Alcorcón, Spain
        • Fundación Hospital Alcorcón
      • Avila, Spain
        • Hospital Nuestra Senora de Sonsoles
      • Badajoz, Spain
        • Hospital Regional Universitario Infanta Cristina
      • Badalona, Spain
        • Hospital de Badalona Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Basurto, Spain
        • Hospital de Basurto
      • Bilbao, Spain
        • Hospital de Cruces
      • Castellón, Spain
        • Hospital General de Castellon
      • Ciudad Real, Spain
        • Hospital Nuestra Señora de Alarcos
      • Cuenca, Spain
        • Hospital Virgen De La Luz
      • Cáceres, Spain
        • Hospital Virgen del Puerto
      • Donostia, Spain
        • Hospital Donostia
      • Elda, Spain
        • Hospital General de Elda
      • Gerona, Spain
        • Institut Català d'Oncologia,
      • Getafe, Spain
        • Hospital Universitario de Getafe
      • Guadalajara, Spain
        • Hospital General de Guadalajara
      • Huesca, Spain
        • Hospital de San Jorge
      • Lanzarote, Spain
        • Hospital General de Lanzarote
      • Lugo, Spain
        • Complejo Hospitalario Xeral-Calde
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital Clínico Universitario San Carlos
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario La Princesa
      • Madrid, Spain
        • Clínica Puerta de Hierro
      • Madrid, Spain
        • Clínica Moncloa
      • Madrid, Spain
        • Clinica Ruber
      • Madrid, Spain
        • Hospital Central de la Defensa
      • Manresa, Spain
        • Althaia, Xarxa Asistencial de Manresa
      • Martorell, Spain
        • Fundación Hospital Sant Joan de Déu de Martorell
      • Murcia, Spain
        • Hospital General Morales Meseguer
      • Murcia, Spain
        • Hospital Santa Maria del Rosell
      • Murcia, Spain
        • Hospital Virgen del Castillo de Yecla
      • Mérida, Spain
        • Hospital de Mérida
      • Móstoles, Spain
        • Hospital De Mostoles
      • Palma de Gran Canaria, Spain
        • Hospital de Gran Canaria Doctor Negrin
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain
        • Complejo Asistencial Son Dureta
      • Palma de Mallorca, Spain
        • Hospital Verge del Toro
      • Pamplona, Spain
        • Clínica Universitaria de Navarra
      • Pamplona, Spain
        • Hospital de Navarra
      • Pamplona, Spain
        • Hospital Virgen del Camino
      • Pontevedra, Spain
        • Complejo Hospitalario de Pontevedra_Hospital Montecelo
      • Pontevedra, Spain
        • Complejo Hospitalario de Pontevedra_Hospital Provincial
      • Sabadell, Spain
        • Corporació Sanitària Parc Taulí
      • Sagunto, Spain
        • Hospital de Sagunto
      • Salamanca, Spain
        • Hospital Clinico De Salamanca
      • San Pedro de Alcántara, Spain
        • Hospital San Pedro de Alcántara
      • Sant Pere de Ribes, Spain
        • Clínica Sant Camil
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago
      • Segovia, Spain
        • Hospital General de Segovia
      • Tarragona, Spain
        • Hospital Joan XXIII
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Toledo, Spain
        • Hospital Virgen De La Salud
      • Toledo, Spain
        • Hospital Nuestra Señora del Prado
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Valencia, Spain
        • Fundacion Instituto Valenciano de Oncologia
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valencia, Spain
        • Hospital Francesc de Borja
      • Valencia, Spain
        • Hospital General Básico de la Defensa
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid
      • Valls, Spain
        • Hospital Comarcal Pius de Valls
      • Vigo, Spain
        • Complejo Hospitalario Universitario de Vigo
      • Vinaros, Spain
        • Comarcal de Vinaros
      • Vitoria, Spain
        • Hospital Txagorritxu
      • Vizcaya, Spain
        • Hospital de Galdakao
      • Zamora, Spain
        • Hospital Virgen de la Concha
      • Zaragoza, Spain
        • Hospital Miguel Servet
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa
    • Aragón
      • Zaragoza, Aragón, Spain
        • Hospital Royo Villanova

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

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to comply with the protocol requirements.
  • Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.
  • Age > 65 years.
  • Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria28 and that has not received any previous chemotherapy treatment for Multiple Myeloma Some steroid doses or bisphosphonates are allowed for emergencies before starting induction treatment.
  • Patient has measurable disease, defined as follows:

For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.

  • Patient has a ECOG performance status < 2
  • Patient has a life-expectancy >3 months.
  • Patient has the following laboratory values before beginning induction treatment:

Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration.

Corrected serum calcium <14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine ≤ 2 mg/dl.

Exclusion Criteria:

  • Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates.
  • Non-secretor Myeloma
  • Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment.
  • Patient had major surgery within 4 weeks before enrolment.
  • Patient has hypersensitivity to bortezomib, boron or mannitol.
  • Patient has received other investigational drugs within 30 days before enrolment.
  • Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
  • Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A

One cycle:

Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)
Drug: Melphalan/Prednisone/Velcade

One cycle:

Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)
Experimental: B

One cycle:

Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)

Five cycles:

Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)
Drug: Thalidomide/Prednisone/Velcade

One cycle:

Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)

Five cycles:

Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

PETHEMA Foundation

Investigators

  • Principal Investigator: Lahuerta Juan josé, Dr, Hospital 12 de Octubre

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

March 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 5, 2007

Study Record Updates

Last Update Posted (Estimate)

September 19, 2011

Last Update Submitted That Met QC Criteria

September 16, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-001111-21

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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