Status:
COMPLETED
VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma
Lead Sponsor:
PETHEMA Foundation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The primary efficacy objective of this study is to study the efficacy in terms of response rate to alternating bortezomib/dexamethasone regimen
Detailed Description
Multiple Myeloma is a plasma cell disorder characterized by an uncontrolled proliferation of bone marrow plasma cells leading to skeletal destruction with bone pain, anemia, renal failure, hypercalcem...
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 18 and under 65 years old.
- 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 poor 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 oligosecretory 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 by immunofixation.
- Patient has a ECOG performance status \< 2.
- 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 ≥ 50x109/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 \< 50x 109/L within 14 days before enrollment.
- Patient has an absolute neutrophil count \< 1.0 x 109/L within 14 days before enrollment.
- 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.
- Pregnancy, breast-feeding or fertile women who are not going to use a medical effective contraceptive method during the trial.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00391157
Start Date
August 1 2005
End Date
January 1 2008
Last Update
September 18 2009
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
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 Clínico San Carlos de Madrid
Madrid, Madrid, Spain