GEM05 for Patients With Multiple Myeloma Under 65 Years (GEM05MENOS65)

September 17, 2009 updated by: PETHEMA Foundation

A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old

The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of up to 390 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 (1:1:1) to receive VBMCP-VBAD+Velcade (Group A) or Thalidomide+Dexamethasone (Group B) or Thalidomide+Dexamethasone+Velcade (Group C). All of them will received the induction treatment up to 24 weeks.

After 4 weeks, without progression or unacceptable toxicity, There will be stem cell mobilization to do an autologous transplant. Three months after transplant, patients will be again randomized (1:1:1) to receive maintenance treatment: Interferon-a (Group M1) or Thalidomide (Group M2) or Thalidomide+Velcade (Group M3) 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)

390

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
      • Alicante, Spain
        • Hospital General de Alicante
      • Avila, Spain
        • Hospital Ntra. Sra. 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
      • Bilbao, Spain
        • Hospital de Cruces
      • Bilbao, Spain
        • Basurtuko Ospitalea
      • 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
      • Getafe, Spain
        • Hospital Universitario de Getafe
      • Guadalajara, Spain
        • Hospital General de Guadalajara
      • Huesca, Spain
        • Hospital de San Jorge
      • Lanzarote, Spain
        • Hospital General de Lanzarote
      • Leon, Spain
        • Complejo Hospitalario León
      • Lugo, Spain
        • Complexo Hospitalario Xeral-Calde
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital Clínico San Carlos de Madrid
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Clínica Puerta de Hierro
      • Madrid, Spain
        • Clínica Moncloa
      • Madrid, Spain
        • Clinica Ruber
      • Madrid, Spain
        • Hospital Central de la Defensa
      • 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
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Palencia, Spain
        • Hospital del Río Carrión
      • Palma de Gran Canaria, Spain
        • Hospital de Gran Canaria Doctor Negrin
      • Palma de Mallorca, Spain
        • Hospital Son Llàtzer
      • Palma de Mallorca, Spain
        • Complejo Asistencial Son Dureta
      • Palma de Mallorca, Spain
        • Hospital Verge del Toro
      • 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
      • Sagunto, Spain
        • Hospital de Sagunto
      • Salamanca, Spain
        • Hospital Clínico de Salamanca
      • San Pedro de Alcántara, Spain
        • Hospital San Pedro de Alcántara
      • Sant Pere de Ribes, Spain
        • Clínica Sant Camil
      • Santander, Spain
        • Hospital Universitario Marques 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
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital Clínic
      • Valencia, Spain
        • Hospital Dr. Peset
      • Valencia, Spain
        • Hospital Francesc de Borja
      • Valencia, Spain
        • Hospital General Básico de la Defensa
      • Valladolid, Spain
        • Hospital Clínico de Valladolid
      • 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 Lozano Blesa
    • Aragón
      • Zaragoza, Aragón, Spain
        • Hospital Royo Villanova
    • Barcelona
      • Manresa, Barcelona, Spain
        • Xarxa assistencial de Manresa
      • Sabadell, Barcelona, Spain
        • Corporació Sanitària Parc Taulí
    • Castellón
      • Castello, Castellón, Spain
        • Hospital General de Castellon
    • Navarra
      • Pamplona, Navarra, Spain
        • Clinica Universitaria de Navarra

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 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must be able to comply with the protocol requirements
  2. Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care,
  3. Age <65 years and possibly to do an autologous transplant.
  4. Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma.
  5. Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours.
  6. ECOG < 2.
  7. El patient has a life-expectancy > 3 months.

  8. Patient has the following laboratory values before beginning induction treatment:

    1. 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.
    2. Corrected serum calcium <14mg/dl.
    3. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal.
    4. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal.
    5. Total bilirubin: ≤1.5 x the upper limit of normal.
    6. Serum creatinine ≤ 2 mg/dl.
  9. For Patients included in Thalidomide branches: women of childbearing age must not have sex unless they use two anticonceptive methods beginning 4 weeks before the first dose, during all the study until 4 weeks after the last one.

Exclusion Criteria:

  1. Non-secretor Myeloma.
  2. Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment.
  3. Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment.
  4. Patient had major surgery within 4 weeks before enrolment.
  5. Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide.
  6. Patient has received other investigational drugs within 30 days before enrolment.
  7. Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
  8. 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.
  9. Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
  10. Pregnancy or breast-feed women.

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

Four alternating cycles of VBMCP/VBAD + Velcade VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalán, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.

VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20. The interval between VBMCP and VBAD is 5 weeks and between VBAD and VBMCP is 4 weeks. The patients will received two cycles of VBMCP and two cycles of VBAD. After 4 weeks of last cycle of VBAD, patients will received two cycles of Velcade, 1,3 mg/ m2 iv twice a week (days 1, 4, 8 and 11), followed by 10 days without treatment
Drug: VBMCP/VBAD/Velcade

VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalan, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.

VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20.
Experimental: B

Six cycles of 4 weeks of Thalidomide/Dexamethasone. Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity < grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.

Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days
Drug: Thalidomide/Dexamethasone

Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity < grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.

Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days
Experimental: C

Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is < grade 2, the dose will be increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.

Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.

Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days.
Drug: Velcade/Thalidomide/Dexamethasone

Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is < grade 2, the dose increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.

Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.

Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

PETHEMA Foundation

Investigators

  • Principal Investigator: Bladé Joan, Dr, Hospital Clinic of Barcelona

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, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-001110-41

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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