An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple Myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 216

Inclusion Criteria

Potential subjects must satisfy the following criteria to be enrolled in the study:
1.Male or female subjects 18 years or older
2.Diagnosis of multiple myeloma based on the standard criteria described in Attachment 1.
3.Measurable, secretory multiple myeloma defined as serum monoclonal IgG of =10 g/L, serum monoclonal IgA or IgE =5 g/L, or serum monoclonal IgD =0.5g/L; or urine M protein of =200 mg/24 hr
4.Relapse or progression of myeloma following prior systemic antineoplastic therapy. Relapse or progression is defined by any of the following:
·Reappearance of measurable disease (as defined above) following CR
·=25% increase in serum or urine M-protein
·Development of new or worsening lytic bone disease
·New plasmacytomas or =50% increase in the longest dimension of an existing plasmacytoma
·Worsening hypercalcemia (corrected serum Ca >11.5 mg/dL [2.8 mmol/L]) due to multiple myeloma
5.Karnofsky performance status =70% (Attachment 2)
6.Platelet count =50 x 10^9/L without transfusion support within 7 days before the laboratory test
7.Hemoglobin =8 g/dL (=4.96 mmol/L) without transfusion support within 7 days before the laboratory test.
8.Absolute neutrophil count (ANC) =0.75 x 10^9/L.
9.Corrected serum Ca <14 mg/dL (<3.5 mmol/L)
10.Aspartate aminotransferase (AST) =2.5X upper limit of normal (ULN)
11.Alanine aminotransferase (ALT) =2.5X ULN
12.Total bilirubin =1.5X ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome)
13.Creatinine clearance =20 mL/min, calculated using the formula in Attachment 3.
14.Toxic effects of previous therapy or surgery have resolved to CTCAE Grade 1 or better
15.Women who are not post-menopausal or surgically sterile must have a negative pregnancy test and agree to use an acceptable method of birth control during the study until 30 days after the last dose of study drug.
16.Men must agree to not father a child and agree to use a latex condom during treatment and for 30 days after the last dose of study drug, even if they have had a successful vasectomy, if their partners are of childbearing potential.
17.Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

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:
1.Previous treatment with VELCADE®
2.More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval)
3.Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade=2
4.Any of the following within 3 weeks prior to randomization: antineoplastic or experimental therapy, corticosteroid use above10 mg/day (prednisone or equivalent), or plasmapheresis
5.Any of the following within 2 weeks prior to randomization: radiation therapy, major surgery (kyphoplasty is not considered major surgery)
6.Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
7.Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities
8.Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes, pericardial disease, acute diffuse infiltrative pulmonary disease, therapeutic use of anticoagulants) that is likely to interfere with study procedures or results (including local injection tolerability), that in the opinion of the investigator would constitute a hazard for participating in this study
9.History of allergic reaction attributable to dexamethasone or its constituents, or compounds containing boron or mannitol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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