Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.
NCT ID: NCT00388635
Last Updated: 2011-01-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-04-30
Study Completion Date
2008-12-31
Brief Summary
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This protocol is planned as a multicentric, national, open-label trial designed to evaluate, first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone. After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003
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Detailed Description
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Multiple Myeloma is a neoplastic disorder of the last maturation stage of B cell, called plasmatic cell. It represents the second most common haematological neoplasia, after Non Hodgkin Lymphoma. The annual incidence is over 4 cases per 100.000. Multiple Myeloma is an invariably mortal disease. When illness advances, the reduction of infections resistance, the intense bones destruction (with bone pain, pathological fractures and hypercalcemia), anaemia, renal failure and, in a less frequency, neurological complications and hyperviscosity provoke severe morbidity and mortality. Five-year survival rate in patients with Multiple Myeloma treated with conventional chemotherapy is 29%. There is an urgent need of new therapeutic agents for the treatment of this disease
Conditions
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Multiple Myeloma
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Interventions
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Velcade
Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
Intervention Type
DRUG
Melphalan
Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
Intervention Type
DRUG
Prednisone
Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Age over 65 years.
* Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria and that has not received any previous chemotherapy treatment for Multiple Myeloma.
* 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.
For oligo or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligo-secretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine.
* Patient has a Karnofsky performance status higher 60%.
* Patient has a life-expectancy \>3 months.
* Patient has the following laboratory values within 14 days before Baseline visit (Day 1 of Cycle 1, before study drug administration:
Platelet count ≥ 100x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L.
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 value ≤ 2mg/dl.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Age over 65 years.
* Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria and that has not received any previous chemotherapy treatment for Multiple Myeloma.
* 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.
For oligo or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligo-secretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine.
* Patient has a Karnofsky performance status higher 60%.
* Patient has a life-expectancy \>3 months.
* Patient has the following laboratory values within 14 days before Baseline visit (Day 1 of Cycle 1, before study drug administration:
Platelet count ≥ 100x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L.
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 value ≤ 2mg/dl.
Exclusion Criteria
* Patient previously received treatment with Velcade.
* Patient previously received treatment for Multiple Myeloma.
* Patient had major surgery within 4 weeks before enrollment.
* Patient has a platelet count \< 100 x 109/L within 14 days before enrollment.
* Patient has an absolute neutrophil count \< 1.0 x 109/L within 14 days before.
* Patient has \< Grade 2 peripheral neuropathy within 14 days before enrollment.
* Patient has hypersensitivity to bortezomib, boron or mannitol.
* Patient has received other investigational drugs within 14 days before enrollment.
* 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.
* Patient previously received treatment for Multiple Myeloma.
* Patient had major surgery within 4 weeks before enrollment.
* Patient has a platelet count \< 100 x 109/L within 14 days before enrollment.
* Patient has an absolute neutrophil count \< 1.0 x 109/L within 14 days before.
* Patient has \< Grade 2 peripheral neuropathy within 14 days before enrollment.
* Patient has hypersensitivity to bortezomib, boron or mannitol.
* Patient has received other investigational drugs within 14 days before enrollment.
* 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.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Sponsor Role
collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Sponsor Role
collaborator
PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
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pethema
Principal Investigators
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San Miguel Jesús, Professor
Role: STUDY_CHAIR
Hospital Clinico Universitario de Salamanca
Locations
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Hospital Clínic
Barcelona, Barcelona, Spain
Site Status
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Site Status
Hospital Germans Trias i Pujol
Barcelona, Barcelona, Spain
Site Status
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Site Status
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Site Status
Hospital Doce de Octubre
Madrid, Madrid, Spain
Site Status
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Site Status
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Site Status
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain
Site Status
Hospital Morales Messeguer
Murcia, Murcia, Spain
Site Status
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Site Status
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Site Status
Hospital Clínic
Valencia, Valencia, Spain
Site Status
Hospital La Fe
Valencia, Valencia, Spain
Site Status
Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
Site Status
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, Spain
Site Status
Hospital Virgen Blanca de León
León, , Spain
Site Status
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Site Status
Hospital General de Segovia
Segovia, , Spain
Site Status
Countries
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Spain
References
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Related Links
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http://www.aehh.org
Spanish association of Haematology
Other Identifiers
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PET-VEL-2004-01
Identifier Type: -
Identifier Source: org_study_id
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