Patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory to or have relapsed after their last therapy for multiple myeloma Classification code 10028228
Conditions
Interventions
Trade Name: Velcade
Product Name: VELCADE3,5 mg powder for solution for injection
Product Code: PS-341
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib
CAS Number
Sponsors
Janssen-Cilag, div.Johnson and Johnson s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient was previously diagnosed with multiple myeloma based on standard criteria. The patient has received at least 2 previous lines of therapy for multiple myeloma and, in the investigators opinion, is refractory to or has relapsed after the last therapy. The patient is of a legally consenting age, as defined by local regulations, and is >18 years of age. The patient is, in the investigators opinion, willing and able to comply with the protocol requirements. The patient has given voluntary written informed consent before performance of any studyrelated procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care. If female, the patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit. If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit. The patient has a Karnofsky performance status >60 (see Attachment 1). The patient meets the following pretreatment laboratory criteria at and within 21 days before baseline (Day 1 of Cycle 1, before study drug administration): Platelet count >30x 109/L, with or without transfusion support. Hemoglobin >7.0 g/dL, with or without transfusion support Absolute neutrophil count (ANC) >0.5 x 109/L. Serum calcium 30 mL/minute. 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
Exclusion criteria: If the patient received VELCADE in a previous clinical trial, the patients best response to VELCADE was progressive disease. If the patient received VELCADE in a previous trial, the patient experienced one or more serious adverse events. Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment. Patient received corticosteroids (>10 mg/day of prednisone or equivalent) within 3 weeks before enrollment. Patient received immunotherapy or antibody therapy within 4 weeks before enrollment. Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Patient had major surgery within 4 weeks before enrollment. (Kyphoplasty is not considered major surgery.) Patient has a history of allergic reaction attributable to compounds containing boron or mannitol. Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC), as follows: Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs); Grade 3: Sensory loss or paresthesia interfering with ADLs; Grade 4:Permanent sensory loss that interferes with function. Patient had a myocardial infarction within 6 months of enrollment or has New 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 has cardiac amyloidosis. Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. Patient known to be HIV-positive. Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. Patient has an active systemic infection requiring treatment. If female, the patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant must be established by a negative serum -hCG pregnancy test during Screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide VELCADE to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory to or have relapsed after their last therapy for multiple myeloma.;Secondary Objective: The secondary objectives are to assess the safety and tolerability of VELCADE and to follow monoclonal paraprotein (M-protein) levels in patients receiving VELCADE as a measure of disease burden.;Primary end point(s): | — |
Countries
Czech Republic, Latvia, Lithuania
Outcome results
None listed