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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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) 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 CNTO 328. Approximately 12 patients will be treated with CNTO 328 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: CNTO 328 + VMP; Arm B: VMP alone) study. Approximately 104 patients will be equally
randomized, followed by a maintenance period with CNTO 328 in patients in Arm A who achieve
a partial response (PR) or better. Patients in both parts of the study will be treated up to
a maximum of nine 6-weeks 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. Patients who will be receiving maintenance treatment
after the 12-month effectiveness analysis may continue to receive treatment with CNTO 328
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients with adverse events in Part 1
Outcome Time Frame:
42 days
Safety Issue:
Yes
Principal Investigator
Janssen Research & Development L.L.C Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Research & Development L.L.C
Authority:
Italy: Ministry of Health
Study ID:
CR015901
NCT ID:
NCT00911859
Start Date:
June 2009
Completion Date:
April 2013
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- CNTO328
- Interleukin-6 (IL-6)
- Monoclonal antibody
- Anti-IL-6 monoclonal antibody
- Bortezomib
- Velcade
- Melphalan
- Prednisone
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina |
