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

PHASE1CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Lymphoma, Non-HodgkinMultiple MyelomaGiant Lymph Node Hyperplasia
Interventions
DRUG

CNTO 328

Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.

Trial Locations (9)

Unknown

Little Rock

Tampa

Atlanta

Box 302

New York

Chapel Hill

Philadelphia

Houston

Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY