A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00412321
• Date of registration: 15/12/2006
• Prospective Registration: No
• Primary sponsor: Centocor, Inc.
• Public title: A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease
• Scientific title: A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease
• Date of first enrolment: May 2005
• Target sample size: 67
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00412321
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with B-cell non-Hodgkin's lymphoma, multiple myeloma, or Castleman's
Disease which has progressed on or after standard therapy or for which there is no
effective standard therapy, or which is not suitable for standard therapy

- Detectable serum C-Reactive Protein

- At least 4 weeks since prior systemic therapy, radiotherapy, or surgery

- Must meet protocol lab criteria (adequate bone marrow, liver and renal function) to
be assessed at patient's first visit to the study center

Exclusion Criteria:

- Received any investigational drug within 30 days or 5 half-lives of the
investigational drug, whichever is longer

- History of receiving murine or human-murine recombination products, such as G250,
BE-8, and other monoclonal antibodies. (Note: Prior rituximab treatment is not an
exclusion criterion)

- Serious concurrent illness or significant cardiac disease characterized by
significant ischemic coronary disease or congestive heart failure

- Known human immunodeficiency virus seropositivity, acquired immunodeficiency syndome,
hepatitis C or active hepatitis B infection. For Cohort 7, known human herpesvirus-8
seropositivity

- Presence of a transplanted solid organ (with the exception of a corneal transplant
more than 3 months prior to screening) or having received an allogeneic bone marrow
transplant or an allogeneic peripheral blood stem cell transplant



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

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Giant Lymph Node Hyperplasia

Lymphoma, Non-Hodgkin

Intervention(s)

Drug: CNTO 328

Primary Outcome(s)

Number of Patients With Adverse Events as a Measure of Safety and Tolerability [Time Frame: Up to 3 years after the last administration of study medication]

Serum Concentration of CNTO 328 [Time Frame: Up to Day 71]

Secondary Outcome(s)

Number of participants with B-cell non-Hodgkin's lymphoma and multiple myeloma who achieved clinical benefit (CB) [Time Frame: Up to Day 71]

Number of participants with Castleman's disease who achieved tumor response [Time Frame: Screening phase (4 weeks before administration of study medication), Day 36, and Day 57]

Pharmacodynamics of CNTO 328 [Time Frame: Up to Day 71]

Number of participants with Castleman's disease who achieved clinical benefit [Time Frame: Up to Day 71]

Number of participants with multiple myeloma who achieved disease response [Time Frame: Screening phase (4 weeks before administration of study medication), Day 36, and Day 57]

Number of participants with B-cell non-Hodgkin's lymphoma who achieved disease response [Time Frame: Screening phase (4 weeks before administration of study medication), Day 36, and Day 57]

Plasma antibodies to CNTO 328 [Time Frame: Up to Week 24]

Secondary ID(s)

CR008566

C0328T03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors