A Prospective, Multicenter, Non-comparative, Open-label, Phase II Study to Evaluate the Effects of the Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Mineral Density, Bone Metabolism, Radiographically-detected Osteolytic Bone Lesions, Skeletal-related Events and Bone Pain in Multiple Myeloma Patients at First Relapse - Not available

• Conditions: This will be a Phase II, prospective, non-comparative, multicenter, open-label study of the effects of the combination of Bortezomib/Dexamethasone/Zoledronic acid on bone mineral density, skeletal related events and bone metabolism in multiple myeloma patients at first relapse.; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2007-005953-49-GR
• Lead Sponsor: Prof. M.A. Dimopoulos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-20
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must satisfy all the following criteria to be enrolled in the study:
•myeloma patients at first relapse
•age = 18 years
•?arnofsky performance status = 60 (patients with lower performance status due to myeloma bone disease can also be included)
•measurable disease
•platelet count >50x109/L
•neutrophil count >0.75x109/L
•hemoglobin =7.0 g/dL (the use of recombinant human erythropoietin or red blood cell transfusions to maintain hemoglobin levels above 7.0 g/dL is not an exclusion criterion)
•serum ALT and AST = 3-fold of upper normal limit
•serum bilirubin = 2-fold of upper normal limit
•serum Calcium = 10.5 mg/dL
•expected survival = 2 months
•signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•presence of another cancer
•serious medical or psychiatric illness likely to interfere with participation in this clinical study
•grade 2-4 peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
•pregnant women or breast-feeding
•women of childbearing potential not using adequate contraception
•known or suspected hypersensitivity or intolerance to bortezomib, boron, mannitol, zoledronic acid, dexamethasone, or heparin (if an indwelling catheter is used)
•uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months prior to first dose of study drug)
•uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 4, NYHA Classification of Cardiac Disease), uncontrolled angina, pericardial disease, or cardiac amyloidosis
•acute diffuse infiltrative pulmonary disease
•history of hypotension or patient has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg)
•patient has received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks prior to enrolment
•patient has received any drugs or agents that inhibit (e.g., cimetidine, erythromycin, fluoxetine, ketoconazole, paroxetine) or induce (e.g., carbamazepine, glucocorticoids, phenobarbital, rifampin) CYP2C19 or CYP3A4 within 14 days before the first dose of VELCADE (proton pump inhibitors are allowed)
•need for therapy with concomitant CYP 3A4 inhibitors (e.g., itraconazole, fluconazole, clarithromycin, erythromycin, norfloxacin, fluvoxamine, cimetidine, indinavir, ritonavir) or inducers (e.g., efavirenz, barbiturates, phenytoin, rifampin, glitazones). Proton pump inhibitors are allowed.
•Patient has received an experimental drug or has used an experimental medical device within 4 weeks prior to the planned start of treatment. Concurrent participation in non-treatment studies is allowed, provided it will not interfere with participation in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified