Clinical trial NCT00443235: GEM05 for Patients With Multiple Myeloma More Than 65 Years Old
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Older patients
untreated patients
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-03-05
Enrollment: 260
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.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.

Primary outcomes:
measure: 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
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
state: Aragón
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alcorcón
country: Spain
facility: Fundación Hospital Alcorcón
city: Avila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
city: Badajoz
country: Spain
facility: Hospital Regional Universitario Infanta Cristina
city: Badalona
country: Spain
facility: Hospital de Badalona Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Basurto
country: Spain
facility: Hospital de Basurto
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Castellón
country: Spain
facility: Hospital General de Castellón
city: Ciudad Real
country: Spain
facility: Hospital Nuestra Señora de Alarcos
city: Cuenca
country: Spain
facility: Hospital Virgen de la Luz
city: Cáceres
country: Spain
facility: Hospital Virgen del Puerto
city: Donostia
country: Spain
facility: Hospital Donostia
city: Elda
country: Spain
facility: Hospital General de Elda
city: Gerona
country: Spain
facility: Institut Català d'Oncologia,
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Guadalajara
country: Spain
facility: Hospital General de Guadalajara
city: Huesca
country: Spain
facility: Hospital de San Jorge
city: Lanzarote
country: Spain
facility: Hospital General de Lanzarote
city: Lugo
country: Spain
facility: Complejo Hospitalario Xeral-Calde
city: Madrid
country: Spain
facility: Clínica Moncloa
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro
city: Madrid
country: Spain
facility: Clínica Rúber
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Central de la Defensa
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Manresa
country: Spain
facility: Althaia, Xarxa Asistencial de Manresa
city: Martorell
country: Spain
facility: Fundación Hospital Sant Joan de Déu de Martorell
city: Murcia
country: Spain
facility: Hospital General Morales Meseguer
city: Murcia
country: Spain
facility: Hospital Santa María del Rosell
city: Murcia
country: Spain
facility: Hospital Virgen del Castillo de Yecla
city: Mérida
country: Spain
facility: Hospital de Mérida
city: Móstoles
country: Spain
facility: Hospital de Móstoles
city: Palma de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Doctor Negrín
city: Palma de Mallorca
country: Spain
facility: Complejo Asistencial Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Palma de Mallorca
country: Spain
facility: Hospital Verge del Toro
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra_Hospital Montecelo
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra_Hospital Provincial
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
city: Sagunto
country: Spain
facility: Hospital de Sagunto
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: San Pedro de Alcántara
country: Spain
facility: Hospital San Pedro de Alcántara
city: Sant Pere de Ribes
country: Spain
facility: Clínica Sant Camil
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Toledo
country: Spain
facility: Hospital Nuestra Señora del Prado
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Francesc de Borja
city: Valencia
country: Spain
facility: Hospital General Básico de la Defensa
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valls
country: Spain
facility: Hospital Comarcal Pius de Valls
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Vinaros
country: Spain
facility: Comarcal de Vinaros
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Vizcaya
country: Spain
facility: Hospital de Galdakao
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital 12 de Octubre
name: Lahuerta Juan josé, Dr
role: PRINCIPAL_INVESTIGATOR
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citation: Lopez-Corral L, Mateos MV, Corchete LA, Sarasquete ME, de la Rubia J, de Arriba F, Lahuerta JJ, Garcia-Sanz R, San Miguel JF, Gutierrez NC. Genomic analysis of high-risk smoldering multiple myeloma. Haematologica. 2012 Sep;97(9):1439-43. doi: 10.3324/haematol.2011.060780. Epub 2012 Feb 13.
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