A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma

NCT01309412 | Terminated Phase 1 DMC

• 2 other identifiers: CR017737JPN-C0328-MM-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the safety and the tolerability of siltuximab up to 11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Relapsed or refractory multiple myeloma; CNTO 328; siltuximab; bortezomib; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events as a measure of safety and tolerability

  Up to 14 months

Secondary Outcomes (3)

• Serum siltuximab concentration

  Maximum 15 weeks

• Number of patients with a positive immune response to siltuximab

  Up to 14 months

• Number of patients with an overall response (complete response and partial response)

  Up to 14 months

Study Arms (1)

Siltuximab

EXPERIMENTAL

Siltuximab 5.5 or 11.0 mg/kg by intravenous infusion over 1 hour on Day 1 of each 21-day cycle until progression

Drug: Siltuximab

Interventions

Siltuximab DRUG

5.5 or 11.0 mg/kg by intravenous infusion over 1 hour on Day 1 of each 21-day cycle until progression

Siltuximab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients proven to have symptomatic or nonsecretory multiple myeloma
• Patients with a measurable lesion
• Patients who have previously received 1-3 regimens for multiple myeloma
• Patients must have progressed on or be refractory to the most recent line of treatment
• Patients with Eastern Cooperative Oncology Group performance status of 0-2
• Patients having the following laboratory values within 14 days before the scheduled day of initial administration of the study drug: hemoglobin 8 g/dL or more, absolute neutrophil count 1,000/mm3 or more, platelet count 50,000/mm3 or more, aspartate aminotransferase, and alanine aminotransferase 2.5 times or more of upper limit of normal range, total bilirubin 1.5 times or more of upper limit of normal range, calculated creatinine clearance 20 mL/min or more, corrected serum calcium less than 12.5 mg/dL

You may not qualify if:

• Patients with primary amyloidosis, plasma cell leukemia or other conditions in which M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
• Patients with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy
• Patients who have undergone allogeneic bone marrow transplantation within 28 days before the start of treatment with the study drug
• Patients who have been exposed to agents targeting interleukin-6 (IL-6) or the IL-6 receptor
• Patients refractory to bortezomib
• Patients having treatment discontinued because of the toxicity of bortezomib
• Patients requiring dose reduction because of the toxicity of bortezomib
• Patients who have received chemotherapy, plasmapheresis or radiation therapy within 21 days before the start of treatment (within 42 days for nitrosoureas)
• Patients who have undergone major surgery including open biopsy (excluding bone marrow) within 21 days before study treatment or planning to have surgery (except for minor surgical procedures) during the study
• Human immunodeficiency virus antibody-positive, hepatitis C virus antibody-positive or hepatitis B surface antigen-positive patients
• Patients with known hypersensitivity to boron or mannitol
• Patients with a history of unmanageable severe infusion reactions to monoclonal antibodies or to murine, chimeric or human proteins or their excipients
• Patients with concurrent medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in the study
• Patients with significant cardiac disease characterized by significant ischemic coronary disease, significant arrhythmias, or congestive heart failure (New York Heart Association Class III or IV) or myocardial infarction within 6 months before the first dose of study drug
• Patients who are clinically diagnosed with pneumonitis (interstitial pneumonia) or pulmonary fibrosis or have abnormal interstitial shadows bilaterally on chest CT, with or without symptoms

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (5)

Unknown Facility

Isehara, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

• Suzuki K, Ogura M, Abe Y, Suzuki T, Tobinai K, Ando K, Taniwaki M, Maruyama D, Kojima M, Kuroda J, Achira M, Iizuka K. Phase 1 study in Japan of siltuximab, an anti-IL-6 monoclonal antibody, in relapsed/refractory multiple myeloma. Int J Hematol. 2015 Mar;101(3):286-94. doi: 10.1007/s12185-015-1743-y. Epub 2015 Feb 6.

  PMID: 25655379 DERIVED

Related Links

• A Phase 1 Study of CNTO 328 (siltuximab) in Combination with Bortezomib and Dexamethasone for Subjects with Relapsed or Refractory Multiple Myeloma

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

siltuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 7, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

JP (5)