Clinical trial · Interventional
A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease
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
NCT00412321CI-TRIAL-00014974completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate of the study of different CNTO 328 doses and schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma or Castleman's disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Lymph Node Hyperplasia | — | UNRESOLVED | — |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNTO 328 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Cohort 1 (CNTO 328)
- description
- Patients will receive 4 administrations of 3 mg/kg CNTO 328 every 2 weeks till Day 43.
- interventionNames
- Drug: CNTO 328
- type
- EXPERIMENTAL
- label
- Cohort 2 (CNTO 328)
- description
- Patients will receive 4 administrations of 6 mg/kg CNTO 328 every 2 weeks till Day 43.
- interventionNames
- Drug: CNTO 328
- type
- EXPERIMENTAL
- label
- Cohort 3 (CNTO 328)
- description
- Patients will receive 3 administrations of 12 mg/kg CNTO 328 every 2 weeks till Day 43.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.