GEM05 for Patients With Multiple Myeloma More Than 65 Years Old

Condition(s) targeted: Multiple Myeloma

Intervention: Melphalan/Prednisone/Velcade (Drug); Thalidomide/Prednisone/Velcade (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Lahuerta Juan josé, Dr, Principal Investigator, Affiliation: Hospital 12 de Octubre

Overall contact:
Lahuerta Juan José, Dr, Phone: 34 91 390 83 22, Email: jjlahuerta@terra.es

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

Official title: 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.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

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.

Minimum age: 66 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Lahuerta Juan José, Dr, Phone: 34 91 390 83 22, Email: jjlahuerta@terra.es

Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain; Recruiting
Palomera Luis, Dr
Palomera Luis, Dr, Principal Investigator

Hospital Miguel Servet, Zaragoza, Spain; Recruiting
Rubio Araceli, Dr, Principal Investigator

Hospital de San Jorge, Huesca, Spain; Recruiting
Puente Fernando, Principal Investigator

Complejo Asistencial Son Dureta, Palma de Mallorca, Spain; Recruiting
Sampol Antonia, Principal Investigator

Hospital Son Llatzer, Palma de Mallorca, Spain; Recruiting
Bargay Joan, Dr, Principal Investigator

Hospital Verge del Toro, Palma de Mallorca, Spain; Recruiting
Galán Pilar, Dr, Principal Investigator

Hospital de Gran Canaria Doctor Negrín, Palma de Gran Canaria, Spain; Recruiting
Suarez Alexia, Dr, Principal Investigator

Hospital General de Lanzarote, Lanzarote, Spain; Recruiting
Calvo José Manuel, Dr, Principal Investigator

Hospital Universitario de Canarias, Tenerife, Spain; Recruiting
Bernardo Gonzalez, Dr, Principal Investigator

Hospital Universitario Marqués de Valdecilla, Santander, Spain; Recruiting
Conde Eulogio, Dr, Principal Investigator

Hospital Nuestra Señora de Alarcos, Ciudad Real, Spain; Recruiting
Hernández Belén, Dr, Principal Investigator

Complejo Hospitalario Universitario de Albacete, Albacete, Spain; Recruiting
Santiago José, Dr, Principal Investigator

Hospital General de Guadalajara, Guadalajara, Spain; Recruiting
Diaz Miguel, Dr, Principal Investigator

Hospital Nuestra Señora del Prado, Toledo, Spain; Recruiting
Solano Fernando, DR, Principal Investigator

Hospital Virgen de la Luz, Cuenca, Spain; Recruiting
Guerra Jose Luis, Dr, Principal Investigator

Hospital Virgen de la Salud, Toledo, Spain; Recruiting
Casado Luis Felipe, Dr, Principal Investigator

Hospital Clínico de Salamanca, Salamanca, Spain; Recruiting
San Miguel Jesús, Dr, Principal Investigator

Hospital General de Segovia, Segovia, Spain; Recruiting
Hernández José Mariano, Principal Investigator

Hospital Nuestra Señora de Sonsoles, Avila, Spain; Recruiting
Barez Abelardo, Dr, Principal Investigator

Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Recruiting
Fernandez Calvo Francisco Javier, Dr, Principal Investigator

Hospital Virgen de la Concha, Zamora, Spain; Recruiting
Martín Alejandro, Dr, Principal Investigator

Althaia, Xarxa Asistencial de Manresa, Manresa, Spain; Recruiting
Subira Maricel, Dr, Principal Investigator

Hospital Clinic i Provincial de Barcelona, Barcelona, Spain; Recruiting
Blade Joan, Dr, Principal Investigator

Hospital de Badalona Germans Trias i Pujol, Badalona, Spain; Recruiting
Oriol Albert, DR, Principal Investigator

Hospital Joan XXIII, Tarragona, Spain; Recruiting
Boixadera Jordi, Dr, Principal Investigator

Institut Català d'Oncologia,, Gerona, Spain; Recruiting
Gonzalez Yolanda, Dr, Principal Investigator

Hospital del Mar, Barcelona, Spain; Recruiting
Abella Eugenia, Dr, Principal Investigator

Corporació Sanitaria Parc Taulí, Sabadell, Spain; Recruiting
Rámila Elena, Dr, Principal Investigator

Hospital Comarcal Pius de Valls, Valls, Spain; Recruiting
Herranz Mª José, Dr, Principal Investigator

Clínica Sant Camil, Sant Pere de Ribes, Spain; Recruiting
Asensio Antonio, Dr, Principal Investigator

Fundación Hospital Sant Joan de Déu de Martorell, Martorell, Spain; Recruiting
Las Heras German, Dr, Principal Investigator

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Recruiting
Sureda Anna, dr, Principal Investigator

Hospital Vall D'Hebron, Barcelona, Spain; Recruiting
Callis Manuel, Dr, Principal Investigator

Hospital Regional Universitario Infanta Cristina, Badajoz, Spain; Recruiting
Fuentes Inmaculada, Dr, Principal Investigator

Hospital de Mérida, Mérida, Spain; Recruiting
Lopez Carlos, Dr, Principal Investigator

Hospital San Pedro de Alcántara, San Pedro de Alcántara, Spain; Recruiting
Martín Mª Luisa, Dr, Principal Investigator

Hospital Virgen del Puerto, Cáceres, Spain; Recruiting
Lopea Rosa, Dr, Principal Investigator

Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, Spain; Recruiting
Allegue Mª José, Dr, Principal Investigator

Complejo Hospitalario de Pontevedra_Hospital Provincial, Pontevedra, Spain; Recruiting
Constela Manuel, Dr, Principal Investigator

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain; Recruiting
Bello Jose Luis, Dr, Principal Investigator

Complejo Hospitalario Universitario de Vigo, Vigo, Spain; Recruiting
Poderós Concepción, Dr, Principal Investigator

Complejo Hospitalario Xeral-Calde, Lugo, Spain; Recruiting
Arias Jesús, Dr, Principal Investigator

Fundación Hospital Alcorcón, Alcorcón, Spain; Recruiting
Peñalver Francisco Javier, Dr, Principal Investigator

Hospital Central de la Defensa, Madrid, Spain; Recruiting
Montero Antonio, Dr, Principal Investigator

Hospital Doce de Octubre, Madrid, Spain; Recruiting
Lahuerta Juan José, Dr, Principal Investigator

Fundación Jiménez Díaz, Madrid, Spain; Recruiting
Prieto Elena, Dr, Principal Investigator

Hospital Universitario de Getafe, Getafe, Spain; Recruiting
Somolinos Nieves, Dr, Principal Investigator

Clínica Moncloa, Madrid, Spain; Recruiting
Perez Angeles, Dr, Principal Investigator

Hospital de Móstoles, Móstoles, Spain; Recruiting
Jaro Esther, Dr, Principal Investigator

Hospital Universitario La Paz, Madrid, Spain; Recruiting
De Paz Raquel, Dr, Principal Investigator

Hospital Universitario La Princesa, Madrid, Spain; Recruiting
Alegre Adrián, Dr, Principal Investigator

Clínica Puerta de Hierro, Madrid, Spain; Recruiting
Krisnk Isabel, Dr, Principal Investigator

Hospital Ramón y Cajal, Madrid, Spain; Recruiting
García Laraña José, Dr, Principal Investigator

Clínica Rúber, Madrid, Spain; Recruiting
Martínez Carmen, Dr, Principal Investigator

Hospital Clínico Universitario San Carlos, Madrid, Spain; Recruiting
Martínez Rafael, Dr, Principal Investigator

Hospital General Morales Meseguer, Murcia, Spain; Recruiting
De Arriba Felipe, Dr, Principal Investigator

Hospital Santa María del Rosell, Murcia, Spain; Recruiting
Ibañez Jerónima, Dr, Principal Investigator

Hospital Virgen del Castillo de Yecla, Murcia, Spain; Recruiting
Esteban Julio, Dr, Principal Investigator

Clínica Universitaria de Navarra, Pamplona, Spain; Recruiting
Prosper Felipe, Dr, Principal Investigator

Hospital Virgen del Camino, Pamplona, Spain; Recruiting
Goñi Mª Angeles, Dr, Principal Investigator

Hospital de Navarra, Pamplona, Spain; Recruiting
Pérez Equiza Katy, dr, Principal Investigator

Hospital de Basurto, Basurto, Spain; Recruiting
Beltran de Heredia José Mª, Dr, Principal Investigator

Hospital de Cruces, Bilbao, Spain; Recruiting
García Juan Carlos, Dr, Principal Investigator

Hospital Donostia, Donostia, Spain; Recruiting
Bengoetxea Enrique, Dr, Principal Investigator

Hospital de Galdakao, Vizcaya, Spain; Recruiting
Ojanguren Jesús, Dr, Principal Investigator

Hospital Txagorritxu, Vitoria, Spain; Recruiting
Menchaca Carmen, Dr, Principal Investigator

Hospital Arnau de Vilanova, Valencia, Spain; Recruiting
Lopez Aurelio, Dr, Principal Investigator

Hospital General Básico de la Defensa, Valencia, Spain; Recruiting
Cáceres Amparo, Dr, Principal Investigator

Hospital General de Castellón, Castellón, Spain; Recruiting
Guinot Maria, Dr, Principal Investigator

Hospital Clínico Universitario de Valencia, Valencia, Spain; Recruiting
Terol Mª Jose, Dr, Principal Investigator

Hospital General de Elda, Elda, Spain; Recruiting
Borrego Domingo, Dr, Principal Investigator

Hospital Universitario La Fe, Valencia, Spain; Recruiting
De la Rubia Javier, Dr, Principal Investigator

Hospital Francesc de Borja, Valencia, Spain; Recruiting
Ruiz Mª Angeles, Dr, Principal Investigator

Fundación Instituto Valenciano de Oncología, Valencia, Spain; Recruiting
Llorente Pablo, Dr, Principal Investigator

Hospital de Sagunto, Sagunto, Spain; Recruiting
Navarro Isabel, Dr, Principal Investigator

Comarcal de Vinaros, Vinaros, Spain; Recruiting
Montagud Mario, Dr, Principal Investigator

Hospital Royo Villanova, Zaragoza, Aragón, Spain; Recruiting
Lopez Luis, Dr, Principal Investigator

Pethema Foundation web

Spanish association of Haematology

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Starting date: March 2005
Ending date: December 2008
Last updated: November 26, 2008