A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Siltuximab11 mg/kg (Drug); Siltuximab 8.3 mg/kg or 11 mg/kg (Drug); Velcade (bortezomib) (Drug); Velcade (bortezomib) (Drug); Melphalan (Drug); Melphalan (Drug); Prednisone (Drug); Prednisone (Drug); Velcade (bortezomib) (Drug); Melphalan (Drug); Prednisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development L.L.C Clinical Trial, Study Director, Affiliation: Janssen Research & Development L.L.C
Summary
The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab)
when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with
VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and
bone marrow).
Clinical Details
Official title: A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
Secondary outcome: Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) CriteriaPercentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria Progression-Free Survival (PFS) 1-year Progression-Free Survival (PFS) Rate Duration of Response (DOR) 1-year Survival Rate Overall Survival Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Detailed description:
The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening
period up to 2 weeks; treatment period; maintenance period (CNTO 328 hereafter referred to
as siltuximab) for a maximum of 18 months and follow up period until the study ends. Part 1
is an open-label (all people know the identity of the intervention), single group safety
lead-in part to evaluate the safety of siltuximab. Approximately 12 patients will be treated
with siltuximab in combination with VMP. If the safety profile of the combination is
acceptable, the study will proceed to Part 2. Part 2 is a randomized (the study medication
is assigned by chance), open-label, 2-arm (Arm A: siltuximab + VMP; Arm B: VMP alone) study.
Approximately 104 patients will be equally randomized, followed by a maintenance period with
siltuximab in particiants in Arm A who achieve a partial response (PR) or better.
Particiants in both parts of the study will be treated up to a maximum of nine 6-week cycles
provided there is no evidence of disease progression, unacceptable toxicity, or withdrawal
from treatment. Study medication will be continued for at least 2 additional cycles after
confirmation of complete response, and preferably for the full 9 cycles of the treatment
period. Participants who will be receiving maintenance treatment after the 12-month
effectiveness analysis may continue to receive treatment with siltuximab only after careful
consideration by the treating physician and on evidence of clinical benefit and in the
absence of unwarranted toxicities. Safety assessments will include evaluation of adverse
events, clinical laboratory tests, eastern cooperative oncology group performance status,
electrocardiogram, vital signs, and physical examination which will be monitored throughout
the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for
high dose chemotherapy with stem cell transplantation
- Eastern cooperative oncology group performance status score of less than or equal to
2
- Measurable secretory disease, defined as either serum monoclonal paraprotein greater
than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours
- Adequate laboratory results that will be confirmed by a study physician
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
- Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or
monoclonal gammopathy of undetermined significance
- Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is
present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Received prior or current systemic therapy or stem cell transplantation for multiple
myeloma
- Peripheral neuropathy or neuropathic pain (Grade 2 or higher)
- Received radiation therapy, plasmapheresis or surgery within 14 days
- Transplanted solid organ, with the exception of a corneal transplant
- Serious concurrent illness or history of uncontrolled heart disease
Locations and Contacts
Adelaide, Australia
Melbourne, Australia
Bordeaux Cedex, France
Montpellier, France
Strasbourg, France
Ahmedabad, India
Calicut, India
Hyderabad N/A, India
Jaipur, India
Mumbai, India
Afula, Israel
Haifa, Israel
Jerusalem, Israel
Petah Tikva, Israel
Ramat-Gan, Israel
Seoul, Korea, Republic of
Bialystok, Poland
Chorzów, Poland
Gdynia, Poland
Lodz, Poland
Wroclaw, Poland
Baia Mare, Romania
Brasov, Romania
Iasi, Romania
Arkhangelsk, Russian Federation
Moscow N/A, Russian Federation
Nizhni Novgorod, Russian Federation
St. Petersburg, Russian Federation
Singapore, Singapore
Barcelona, Spain
Madrid, Spain
Murcia N/A, Spain
Salamanca, Spain
Boston, Massachusetts, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Additional Information
Starting date: June 2009
Last updated: November 17, 2014
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