E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10028228 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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performance of any studyrelated procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.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 <3.5 mmol/L (14 mg/dL). Aspartate transaminase (AST): <2.5 x the upper limit of normal (ULN). Alanine transaminase (ALT): <2.5 x the ULN. Total bilirubin: <1.5 x the ULN. Calculated (see Attachment 2) or measured creatinine clearance: >30 mL/minute. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |