Back to resultsGEM05 for Patients With Multiple Myeloma More Than 65 Years Old
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Melphalan/Prednisone/Velcade
Thalidomide/Prednisone/Velcade
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Older patients, untreated patients
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before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.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.
Sites / Locations
- Hospital Royo Villanova
- Complejo Hospitalario Universitario de Albacete
- Fundación Hospital Alcorcón
- Hospital Nuestra Señora de Sonsoles
- Hospital Regional Universitario Infanta Cristina
- Hospital de Badalona Germans Trias i Pujol
- Hospital Clinic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital del Mar
- Hospital Vall D'Hebron
- Hospital de Basurto
- Hospital de Cruces
- Hospital General de Castellón
- Hospital Nuestra Señora de Alarcos
- Hospital Virgen de la Luz
- Hospital Virgen del Puerto
- Hospital Donostia
- Hospital General de Elda
- Institut Català d'Oncologia,
- Hospital Universitario de Getafe
- Hospital General de Guadalajara
- Hospital de San Jorge
- Hospital General de Lanzarote
- Complejo Hospitalario Xeral-Calde
- Clínica Moncloa
- Clínica Puerta de Hierro
- Clínica Rúber
- Fundación Jiménez Díaz
- Hospital Central de la Defensa
- Hospital Clínico Universitario San Carlos
- Hospital Doce de Octubre
- Hospital Ramón y Cajal
- Hospital Universitario La Paz
- Hospital Universitario La Princesa
- Althaia, Xarxa Asistencial de Manresa
- Fundación Hospital Sant Joan de Déu de Martorell
- Hospital General Morales Meseguer
- Hospital Santa María del Rosell
- Hospital Virgen del Castillo de Yecla
- Hospital de Mérida
- Hospital de Móstoles
- Hospital de Gran Canaria Doctor Negrín
- Complejo Asistencial Son Dureta
- Hospital Son Llatzer
- Hospital Verge del Toro
- Clínica Universitaria de Navarra
- Hospital de Navarra
- Hospital Virgen del Camino
- Complejo Hospitalario de Pontevedra_Hospital Montecelo
- Complejo Hospitalario de Pontevedra_Hospital Provincial
- Corporació Sanitaria Parc Taulí
- Hospital de Sagunto
- Hospital Clínico de Salamanca
- Hospital San Pedro de Alcántara
- Clínica Sant Camil
- Hospital Universitario Marqués de Valdecilla
- Complejo Hospitalario Universitario de Santiago
- Hospital General de Segovia
- Hospital Joan XXIII
- Hospital Universitario de Canarias
- Hospital Nuestra Señora del Prado
- Hospital Virgen de la Salud
- Fundación Instituto Valenciano de Oncología
- Hospital Arnau de Vilanova
- Hospital Clínico Universitario de Valencia
- Hospital Francesc de Borja
- Hospital General Básico de la Defensa
- Hospital Universitario La Fe
- Hospital Clínico Universitario de Valladolid
- Hospital Comarcal Pius de Valls
- Complejo Hospitalario Universitario de Vigo
- Comarcal de Vinaros
- Hospital Txagorritxu
- Hospital de Galdakao
- Hospital Virgen de la Concha
- Hospital Clínico Universitario Lozano Blesa
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00443235
Brief Title
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Older patients, untreated patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
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)
Arm Title
B
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Melphalan/Prednisone/Velcade
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Thalidomide/Prednisone/Velcade
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lahuerta Juan josé, Dr
Organizational Affiliation
Hospital 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Royo Villanova
City
Zaragoza
State/Province
Aragón
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Fundación Hospital Alcorcón
City
Alcorcón
Country
Spain
Facility Name
Hospital Nuestra Señora de Sonsoles
City
Avila
Country
Spain
Facility Name
Hospital Regional Universitario Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Hospital de Badalona Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital de Basurto
City
Basurto
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
Country
Spain
Facility Name
Hospital General de Castellón
City
Castellón
Country
Spain
Facility Name
Hospital Nuestra Señora de Alarcos
City
Ciudad Real
Country
Spain
Facility Name
Hospital Virgen de la Luz
City
Cuenca
Country
Spain
Facility Name
Hospital Virgen del Puerto
City
Cáceres
Country
Spain
Facility Name
Hospital Donostia
City
Donostia
Country
Spain
Facility Name
Hospital General de Elda
City
Elda
Country
Spain
Facility Name
Institut Català d'Oncologia,
City
Gerona
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
Country
Spain
Facility Name
Hospital General de Guadalajara
City
Guadalajara
Country
Spain
Facility Name
Hospital de San Jorge
City
Huesca
Country
Spain
Facility Name
Hospital General de Lanzarote
City
Lanzarote
Country
Spain
Facility Name
Complejo Hospitalario Xeral-Calde
City
Lugo
Country
Spain
Facility Name
Clínica Moncloa
City
Madrid
Country
Spain
Facility Name
Clínica Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Clínica Rúber
City
Madrid
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Facility Name
Hospital Central de la Defensa
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Althaia, Xarxa Asistencial de Manresa
City
Manresa
Country
Spain
Facility Name
Fundación Hospital Sant Joan de Déu de Martorell
City
Martorell
Country
Spain
Facility Name
Hospital General Morales Meseguer
City
Murcia
Country
Spain
Facility Name
Hospital Santa María del Rosell
City
Murcia
Country
Spain
Facility Name
Hospital Virgen del Castillo de Yecla
City
Murcia
Country
Spain
Facility Name
Hospital de Mérida
City
Mérida
Country
Spain
Facility Name
Hospital de Móstoles
City
Móstoles
Country
Spain
Facility Name
Hospital de Gran Canaria Doctor Negrín
City
Palma de Gran Canaria
Country
Spain
Facility Name
Complejo Asistencial Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Verge del Toro
City
Palma de Mallorca
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra_Hospital Montecelo
City
Pontevedra
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra_Hospital Provincial
City
Pontevedra
Country
Spain
Facility Name
Corporació Sanitaria Parc Taulí
City
Sabadell
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
San Pedro de Alcántara
Country
Spain
Facility Name
Clínica Sant Camil
City
Sant Pere de Ribes
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital General de Segovia
City
Segovia
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Facility Name
Hospital Nuestra Señora del Prado
City
Toledo
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Francesc de Borja
City
Valencia
Country
Spain
Facility Name
Hospital General Básico de la Defensa
City
Valencia
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Name
Hospital Comarcal Pius de Valls
City
Valls
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
Country
Spain
Facility Name
Comarcal de Vinaros
City
Vinaros
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
Country
Spain
Facility Name
Hospital de Galdakao
City
Vizcaya
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology
Learn more about this trial
GEM05 for Patients With Multiple Myeloma More Than 65 Years Old
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