An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00431769
• Date of registration: 02/02/2007
• Prospective Registration: No
• Primary sponsor: Janssen-Cilag International NV
• Public title: An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma
• Scientific title: A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade
• Date of first enrolment: June 2006
• Target sample size: 130
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00431769
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, France, Germany, Greece, Luxembourg, Portugal, Spain

Contacts

• Name: Janssen-Cilag International NV Clinical Trial
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Bortezomib

Primary Outcome(s)

Best Confirmed Response to Bortezomib Re-Treatment [Time Frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)]

Secondary Outcome(s)

Duration of Best Confirmed Response (DOR) [Time Frame: Day 1 Cycle 1 up to last follow-up visit (8 weeks until PD)]

Time to Progression (TTP) for Best Confirmed Response [Time Frame: (Day 1 Cycle 1 up to last follow-up visit date (8 weeks until PD)]

Participants With Percent Change in Baseline Serum Monoclonal Protein (M-protein) Best Confirmed Response Category [Time Frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)]

Participants with Percent Change in Baseline Urine Monoclonal Protein (M-protein) Best Confirmed Response Category [Time Frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)]

Secondary ID(s)

CR010519

2005-005819-26

26866138MMY2036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors