An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00402181
• Date of registration: 17/11/2006
• Prospective Registration: No
• Primary sponsor: Centocor, Inc.
• Public title: An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma
• Scientific title: A Phase 2 Multicenter Study of CNTO 328 (Anti IL-6 Monoclonal Antibody) in Subjects With Relapsed or Refractory Multiple Myeloma
• Date of first enrolment: October 2006
• Target sample size: 53
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00402181
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

India, Netherlands, United States

Contacts

• Name: Centocor, Inc. Clinical Trial
• Affiliation: Centocor, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of multiple myeloma with relapsed or refractory disease after
failing at least 2 prior lines of therapy

- Prior treatment regimen must have included bortezomib (alone or in combination with
other agents)

- Measurable secretory disease defined as either serum monoclonal paraprotein (M-
protein) greater than or equal to (>=) 1 gram per deciliter (g/dL) or urine
monoclonal (light chain) protein (greater than (>) 200 milligram/24 hours)

- Eastern Cooperative Oncology Group (ECOG) performance status score of less than or
equal to (<=) 2 - Participants of childbearing potential must use adequate birth
control measures, female participants of childbearing potential must have a negative
serum pregnancy test at screening

Exclusion Criteria:

- Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy
within 30 days before the first dose of study agent - Treatment with nitrosoureas (a
group of alkylating agents used as antineoplastic drugs in the chemotherapy) within
42 days before the first dose of study agent

- Major surgery within 30 days before the first dose of study agent or planning to have
surgery (except for minor surgical procedures) during the study

- Serious concurrent illness (medical or psychiatric), uncontrolled infection, or
significant cardiac disease characterized by significant ischemic coronary disease
(an imbalance between myocardial functional requirements and the capacity of the
coronary vessels to supply sufficient blood flow) or congestive heart failure
(condition in which the heart is unable to pump out sufficient blood to meet the
metabolic need of the body) not under medical control, or any uncontrolled medical
condition (for example: uncontrolled diabetes), including the presence of clinical
laboratory abnormalities, that places the subject at unacceptable risk by
participating in the study or confounds the ability to interpret data from the study

- Known to be seropositive (giving a positive result in a test of blood serum) for
Human Immunodeficiency Virus (HIV), or active hepatitis A, B or C infection



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

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Biological: Siltuximab

Drug: Dexamethasone

Primary Outcome(s)

Percentage of Participants With Overall Response [Time Frame: Baseline up to end of study (Day 807)]

Secondary Outcome(s)

Percent Change From Baseline in C-telopeptide (CTx) Level [Time Frame: Before siltuximab administration on Day 1 of cycles 1, 2, and 3]

Duration of Response [Time Frame: Baseline up to end of study (Day 807)]

Percent Change From Baseline in N-telopeptide (NTx) Level [Time Frame: Before siltuximab administration on Day 1 of cycles 1, 2, and 3]

Number of Participants With Immune Response [Time Frame: Day 1 (Cycle 1 [pre-dose]), treatment discontinuation, and every 3 months after the last dose (up to 3 times)]

Time to Progression (TTP) [Time Frame: Baseline up to end of study (Day 807)]

Percent Change From Baseline in C-Reactive Protein (CRP) Level [Time Frame: Before siltuximab administration in Cycles 1, 2, and 3 on Days 1 and 15; thereafter, on Day 1 of each cycle up to12 cycles]

Secondary ID(s)

2006-001897-26

C0328T05

CR012631

Source(s) of Monetary Support

Please refer to primary and secondary sponsors