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

NCT00402181 | Completed Phase 2 DMC

• 3 other identifiers: CR012631C0328T052006-001897-26
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 13

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of siltuximab in participants with relapsed (the return of a disease or the signs and symptoms of a disease after a period of improvement.) or refractory (cancer that does not respond to treatment) multiple myeloma (a type of cancer that begins in plasma cells \[white blood cells that produce antibodies\]).

Conditions

Multiple Myeloma

Keywords

Myeloma; Intravenous; Monoclonal antibody; Siltuximab; Dexamethasone; CNTO 328

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Response

  The overall response is defined as percentage of participants having confirmed Complete Response (CR) and Partial Response (PR) by using the European Group for Blood and Marrow Transplantation (EBMT) criteria. CR is absence of the original monoclonal protein (M-protein) in serum and urine maintained for a minimum of 6 weeks, and disappearance of soft tissue plasmacytomas. PR is greater than or equal to (\>=) 50 percent reduction in the level of the serum M-protein maintained for a minimum of 6 weeks and \>= 50 percent reduction in the size of soft tissue plasmacytomas.

  Baseline up to end of study (Day 807)

Secondary Outcomes (6)

• Time to Progression (TTP)

  Baseline up to end of study (Day 807)

• Duration of Response

  Baseline up to end of study (Day 807)

• Number of Participants With Immune Response

  Day 1 (Cycle 1 [pre-dose]), treatment discontinuation, and every 3 months after the last dose (up to 3 times)

• Percent Change From Baseline in C-Reactive Protein (CRP) Level

  Before siltuximab administration in Cycles 1, 2, and 3 on Days 1 and 15; thereafter, on Day 1 of each cycle up to12 cycles

• Percent Change From Baseline in C-telopeptide (CTx) Level

  Before siltuximab administration on Day 1 of cycles 1, 2, and 3

Study Arms (2)

Treatment Plan A

EXPERIMENTAL

Siltuximab 6 milligram per kilogram (mg/kg) as intravenous (directly into the vein) infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days (if participant have complete or partial response) along with dexamethasone (starting from Cycle 2, If participant do not have complete or partial response) 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles.

Biological: Siltuximab; Drug: Dexamethasone

Treatment Plan B

EXPERIMENTAL

Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks along with dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles (duration of each cycle is 28 days) after that on Day 1 to 4 up to 12 cycles.

Biological: Siltuximab; Drug: Dexamethasone

Interventions

Siltuximab BIOLOGICAL

Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days.

Also known as: CNTO 328

Treatment Plan A; Treatment Plan B

Dexamethasone DRUG

Dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles and duration of each cycle is 28 days.

Treatment Plan A; Treatment Plan B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (13)

Unknown Facility

Duarte, California, United States

Location

Unknown Facility

Norwalk, Connecticut, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

North Charleston, South Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Leiden, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

The Hague, Netherlands

Location

Related Links

• A Phase 2 Multicenter Study of CNTO 328 (Anti IL-6 Monoclonal Antibody) in Subjects With Relapsed or Refractory Multiple Myeloma

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

siltuximab; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (9); NL (4)