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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

This research study will use a type of drug called anti-IL-6 antibody, also known as CNTO
328. An antibody is a substance in the body that fights infection. CNTO 328 is an
investigational drug that has been shown to slow down tumor growth or shrink tumors when
tested in animals.

The purpose of this study is to see what effects (good and bad) CNTO 328 has on relapsed or
refractory multiple myeloma. In this study, patients will begin by taking CNTO 328 alone.
The doctor will routinely check the patient's cancers response to CNTO 328. If CNTO 328 does
not help on its own, patients may be given CNTO 328 with dexamethasone. Dexamethasone is a
corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is
often given to multiple myeloma patients in combination with other chemotherapy to treat

The study will be approximately 12 months and then there is a follow-up period that will
last until the study ends. The study will end 16 months after the last patient is entered
into this study. The study is divided into four different phases: Screening phase which
lasts up to 4 weeks. During this phase the study doctor will perform tests to see if the
patient can participate in the study. Treatment phase which may last up to 12 cycles of 28
days each. During these cycles the patient will be treated with CNTO 328 every two weeks.
Two infusions complete a single cycle. Dexamethasone may be added to the patient's
treatment cycle. The end of treatment visit occurs 4 weeks after the patient's last dose of
CNTO 328. The treatment phase will last about 52 weeks. Follow-up phase, which will begin
after the patient's end of treatment visit and continue until the end of the study. If the
patient's cancer has not worsened, the study doctor will perform a disease assessment every
6 weeks during this time until the patient's disease progresses. Whether or not the
patient's cancer has worsened the patient will also be asked to return every 3 months for 3
visits after the patient's final treatment cycle. The patient's medical charts will be
reviewed during this time period. Extended dosing phase, during which, if the patient's
cancer has stayed the same or improved while receiving CNTO 328, the patient may be able to
receive additional courses of the study drug after they have completed the 12 study cycles;
this will increase the patient's participation time on the study. Patients will receive 6
milligrams of medication per kilogram of body weight (mg/kg) CNTO 328 intravenously (into
the vein) over 2 hours every 2 weeks, on days 1 and 15 of each 28 day cycle. Patients will
receive up to 12 cycles, patients who respond with stable disease or better may receive
additional cycles.

Inclusion Criteria:

- 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) >= 1 g/dL or urine monoclonal (light chain) protein (> 200 mg/24 hours)

- ECOG performance status score of <= 2

- Must meet protocol lab criteria-patient's will be assessed at the first visit to the
study center

Exclusion Criteria:

- Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy
within 30 days before the first dose of study agent or treatment with nitrosoureas
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

- Received an allogeneic bone marrow or allogeneic peripheral blood stem cell
transplant or has clinically significant residual toxicities associated with prior
autologous bone marrow or peripheral blood stem cell transplant

- Serious concurrent illness (medical or psychiatric), uncontrolled infection, or
significant cardiac disease characterized by significant ischemic coronary disease or
congestive heart failure not under medical control, or any uncontrolled medical
condition (eg, 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 for HIV, or active hepatitis A, B or C infection

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objectives of this study are to assess the safety and effectiveness of CNTO 328 administered as an infusion into the vein in patients with relapsed or refractory multiple myeloma

Outcome Time Frame:

throughout the course of the trial

Safety Issue:


Principal Investigator

Centocor, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Centocor, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

July 2009

Related Keywords:

  • Multiple Myeloma
  • myeloma
  • intravenous
  • monoclonal antibody
  • dexamethasone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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