Status:
COMPLETED
Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 do...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00388635
Start Date
April 1 2004
End Date
December 1 2008
Last Update
January 11 2011
Active Locations (19)
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1
Hospital Clínic
Barcelona, Barcelona, Spain
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
3
Hospital Germans Trias i Pujol
Barcelona, Barcelona, Spain
4
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain