Clinical trial NCT00431769 (phase 2, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Participant was previously diagnosed with multiple myeloma based on standard criteria
             and had measurable disease. Measurable disease for secretory multiple myeloma was
             defined as any quantifiable serum M-protein value (generally, but not exclusively,
             greater than (>) 1 gram per deciliter (g/dL) immunoglobulin (Ig) G Myeloma protein
             (M-protein) and >0.5 g/dL Ig A) or urine light-chain excretion of equal to (=) or >200
             milligram (mg)/24 hour

          -  Participant previously tolerated 1.0 or 1.3 mg/metersquare (m^2) bortezomib alone or
             in combination with other agents and had complete response (CR) or partial response
             (PR) upon completion of bortezomib therapy

          -  It had been greater than or equal to (>=) 6 months since the participant's last
             bortezomibdose and the participant had progressive disease (PD) if prior response to
             bortezomib was PR or the participant had relapsed from CR

          -  Participant had a life expectancy >3 months

          -  If female, the participant was either postmenopausal or surgically sterilized or
             willing to use an acceptable method of birth control from screening through at least
             30 days after completion of the last cycle

        Exclusion Criteria:

          -  Participant had received chemotherapy, radiotherapy, antibody, immunotherapy, or
             experimental therapy to treat multiple myeloma since their last dose of bortezomib.
             Note: participants could have received localized palliative radiotherapy for
             complications due to osteolytic bone lesions. Participants could have received
             steroids (dexamethasone or equivalent) or thalidomide or interferon as maintenance
             therapy since their last dose of bortezomib according to local standard of care. In
             addition, participants could have received a cumulative dose of up to 160 mg
             dexamethasone or equivalent as emergency therapy within 4 weeks prior to enrolment.
             Participants could have received high dose therapy/stem cell transplantation after
             induction regimen containing bortezomib, but only if PR or CR was observed during
             bortezomib containing induction therapy

          -  Participant had uncontrolled or severe cardiovascular disease, including myocardial
             infarction within 6 months of enrolment or had New York Heart Association Class III or
             IV heart failure, uncontrolled angina, clinically significant pericardial disease,
             severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities

          -  Participant had poorly controlled hypertension, diabetes mellitus, or other serious
             medical or psychiatric illness that could potentially interfere with the completion of
             treatment according to the protocol

          -  Participant had another malignancy within the past 5 years. Exceptions were made for
             the following if they were treated and not active: basal cell or non-metastatic
             squamous cell carcinoma of the skin, cervical carcinoma in situ or International
             Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix

          -  Patient has an uncontrolled or severe cardiovascular disease, within 6 months of
             enrolment

          -  Female participant was pregnant or breast feeding. Confirmation that the participant
             was not pregnant was to be established by a negative beta human chorionic gonadotropin
             pregnancy test result obtained during the Screening period. Pregnancy testing was not
             required for post menopausal or surgically sterilized women.