Status:
COMPLETED
GEM05 for Patients With Multiple Myeloma More Than 65 Years Old
Lead Sponsor:
PETHEMA Foundation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
66+ years
Phase:
PHASE3
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 evaluat...
Eligibility Criteria
Inclusion
- 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before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00443235
Start Date
March 1 2005
End Date
December 1 2009
Last Update
September 19 2011
Active Locations (77)
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1
Hospital Royo Villanova
Zaragoza, Aragon, Spain
2
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
3
Fundación Hospital Alcorcón
Alcorcón, Spain
4
Hospital Nuestra Señora de Sonsoles
Ávila, Spain