GEM05 for Patients With Multiple Myeloma Under 65 Years
Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: VBMCP/VBAD/Velcade (Drug); Thalidomide/Dexamethasone (Drug); Velcade/Thalidomide/Dexamethasone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: PETHEMA Foundation Official(s) and/or principal investigator(s): Bladé Joan, Dr, Principal Investigator, Affiliation: Hospital Clinic of Barcelona
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.
Secondary outcome: 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
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.
Eligibility
Minimum age: N/A.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Complejo Hospitalario Universitario de Albacete, Albacete, Spain
Fundación Hospital Alcorcón, Alcorcón, Spain
Hospital General de Alicante, Alicante, Spain
Hospital Ntra. Sra. Sonsoles, Avila, Spain
Hospital Regional Universitario Infanta Cristina, Badajoz, Spain
Hospital de Badalona Germans Trias i Pujol, Badalona, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hospital del Mar, Barcelona, Spain
Hospital Vall D'Hebron, Barcelona, Spain
Basurtuko Ospitalea, Bilbao, Spain
Hospital de Cruces, Bilbao, Spain
Hospital Nuestra Señora de Alarcos, Ciudad Real, Spain
Hospital Virgen de la Luz, Cuenca, Spain
Hospital Virgen del Puerto, Cáceres, Spain
Hospital Donostia, Donostia, Spain
Hospital General de Elda, Elda, Spain
Hospital Universitario de Getafe, Getafe, Spain
Hospital General de Guadalajara, Guadalajara, Spain
Hospital de San Jorge, Huesca, Spain
Hospital General de Lanzarote, Lanzarote, Spain
Complejo Hospitalario León, Leon, Spain
Complexo Hospitalario Xeral-Calde, Lugo, Spain
Clínica Moncloa, Madrid, Spain
Clínica Puerta de Hierro, Madrid, Spain
Clínica Rúber, Madrid, Spain
Fundación Jiménez Díaz, Madrid, Spain
Hospital 12 de Octubre, Madrid, Spain
Hospital Central de la Defensa, Madrid, Spain
Hospital Clínico San Carlos de Madrid, Madrid, Spain
Hospital Ramón y Cajal, Madrid, Spain
Hospital Universitario de la Princesa, Madrid, Spain
Hospital Universitario La Paz, Madrid, Spain
Fundación Hospital Sant Joan de Déu de Martorell, Martorell, Spain
Hospital General Morales Meseguer, Murcia, Spain
Hospital Santa María del Rosell, Murcia, Spain
Hospital Virgen del Castillo de Yecla, Murcia, Spain
Hospital de Mérida, Mérida, Spain
Hospital Central de Asturias, Oviedo, Spain
Hospital del Río Carrión, Palencia, Spain
Hospital de Gran Canaria Doctor Negrín, Palma de Gran Canaria, Spain
Complejo Asistencial Son Dureta, Palma de Mallorca, Spain
Hospital Son Llatzer, Palma de Mallorca, Spain
Hospital Verge del Toro, Palma de Mallorca, Spain
Hospital de Navarra, Pamplona, Spain
Hospital Virgen del Camino, Pamplona, Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, Spain
Complejo Hospitalario de Pontevedra_Hospital Provincial, Pontevedra, Spain
Hospital de Sagunto, Sagunto, Spain
Hospital Clínico de Salamanca, Salamanca, Spain
Hospital San Pedro de Alcántara, San Pedro de Alcántara, Spain
Clínica Sant Camil, Sant Pere de Ribes, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
Hospital General de Segovia, Segovia, Spain
Hospital Joan XXIII, Tarragona, Spain
Hospital Universitario de Canarias, Tenerife, Spain
Hospital Nuestra Señora del Prado, Toledo, Spain
Hospital Virgen de la Salud, Toledo, Spain
Fundación Instituto Valenciano de Oncología, Valencia, Spain
Hospital Arnau de Vilanova, Valencia, Spain
Hospital Clínic, Valencia, Spain
Hospital Dr. Peset, Valencia, Spain
Hospital Francesc de Borja, Valencia, Spain
Hospital General Básico de la Defensa, Valencia, Spain
Hospital La Fe, Valencia, Spain
Hospital Clínico de Valladolid, Valladolid, Spain
Complejo Hospitalario Universitario de Vigo, Vigo, Spain
Comarcal de Vinaros, Vinaros, Spain
Hospital Txagorritxu, Vitoria, Spain
Hospital de Galdakao, Vizcaya, Spain
Hospital Virgen de la Concha, Zamora, Spain
Hospital Clínico Lozano Blesa, Zaragoza, Spain
Hospital Miguel Servet, Zaragoza, Spain
Hospital Royo Villanova, Zaragoza, Aragón, Spain
Xarxa assistencial de Manresa, Manresa, Barcelona, Spain
Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
Hospital general de Castellón, Castello, Castellón, Spain
Clínica Universitaria de Navarra, Pamplona, Navarra, Spain
Additional Information
Spanish association of Haematology
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Starting date: March 2006
Last updated: September 17, 2009
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