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Study Summary
No. 2007-0479:.......Myeloma......Sheeba K. Thomas......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2007-0479
Study Title:A Phase 2 Multicenter Study of CNTO 328 (Anti IL-6 Monoclonal Antibody) in Subjects with Relapsed or Refractory Multiple Myeloma
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Physician New Patient Referral
Name:Sheeba K. ThomasPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:MyelomaSupported By:Centocor, Inc / Centocor, B.V.
Phase of Study:Phase IIReturn
Visit:
Pts must return for CNTO 328 every 2 wks (D 1 and 15), and response evaluation
is performed on D 22 of each 28 day cycle.

Tx will be given for up to 12 cycles. If the pt is benefiting from tx after 12
cycles, cont of tx may be discussed w/Sponsor.
Treatment
Agents:
CNTO 328
Dexamethasone
Home Care:None
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
NA
Description/
Intervention:
The goal of this clinical research study is to learn if CNTO 328 with or
without dexamethasone can help to control the disease in patients with MM that
has come back or is resistant to treatment. The safety of CNTO 328 will also be
studied.
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Study Objectives / Outcomes
The primary objectives of this study are to assess the safety and efficacy of CNTO 328 administered as an IV infusion in subjects with relapsed or refractory multiple myeloma.

The secondary objectives are to assess the pharmacokinetics, pharmacodynamics, and immune response of CNTO 328 administered as an IV infusion in subjects with relapsed or refractory multiple myeloma.
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Study Status Information
Study Activation / Registration Date:02/14/2008
IRB Review and Approval Date:09/05/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:90
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Male or female and >/= 18 years

2) Signed informed consent obtained prior to any study-specific screening procedures

3) Sites participating in genetic testing: Subjects must have signed the informed consent for genetic testing indicating whether they do or do not wish to participate in the genetic part of the study. Participation in the genetic testing component is not mandatory for participation in the study

4) Confirmed diagnosis of multiple myeloma

5) Relapsed or refractory disease defined as: Failed at least 2 prior lines of therapy, documented relapse after completion of last treatment or no response to last prior therapy. Progression on prior therapy is defined according to EBMT criteria

6) Continued from Inclusion #5: Other acceptable prior lines of therapy include: High-dose corticosteroids, autologous stem cell transplant (high-dose coritcosteroids followed by autologous stem cell transplant are considered 1 line of therapy), lenalidomide/thalidomide (alone or in combination with other agents), anthracycline and/or alkalylating agent (melphalan) (alone or in combination with other agents), and bortezomib (alone or in combination with other agents)

7) Prior treatment regimen must have included bortezomib (alone or in combination with other agents)

8) Measurable secretory disease defined as either serum monoclonal paraprotein (M-protein) >/= 1 g/dL or urine monoclonal (light chain) protein (> 200 mg/24 hours)

9) ECOG performance status score of </= 2

10) Subjects experiencing toxicites resulting from previous therapy must have fully recovered or stabilized to </= Grade 1

11) Subjects of childbearing potential must use adequate birth control measures. Female subjects of childbearing potential must have a negative serum pregnancy test at screening

12) Adequate bone marrow, liver, and renal function prior to treatment: hemaglobin >/= 7.5 g/dL (4.7 mmol/L; 75 g/L) with or without transfusion dependency, Platelets >/= 50,000/mm^3 without transfusion dependency, Absolute neutrophil count (ANC) >/= 1000 mm^3 without hematopoietic cytokine support, AST, ALT, and alkaline phosphatase </= 3 x ULN, Bilirubin </= 2 x ULN, Calculated creatinine clearance >/=20 mL/min, Corrected serum calcium </= 11.5 mg/dL (2.8 mmol/L)

13) Able to adhere to study visit schedule and all protocol requirements

Exclusion Criteria:1) Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent

2) Treatment with nitrosoureas within 42 days before the first dose of study agent

3) Major surgery within 30 days before the first dose of study afent or planning to have surgery (except for minor surgical procedures) during the study

4) Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer

5) Received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant

6) Has clinically significant residual toxicities associated with prior autologous bone marrow or peripheral blood stem cell transplant

7) Administered platelet transfusion or neutrophil growth factor within 2 weeks prior to the collection of screening hematology laboratory sample

8) Transplanted solid organ with the exception of a corneal transplant (>/= 3 months prior to screening)

9) Received any mAB within 60 days of first dose of study agent

10) Serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characheterized 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

11) Prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has been disease-free for >/= 3 years

12) Any other concomitant disease-related treatment such as, immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or immunosuppressive therapy/corticoid steroids (other than study specific treatment with dexamethasone. However, physiological low doses of corticosteroids for adrenal insufficiency or occasional pretreatment to prevent allergic reactions (eg, to contrast materials) are allowed.

13) Vaccinated with live, attenuated vaccines within 4 weeks of the first administration of CNTO 328

14) Known to be seropositive for HIV, or active hepatitis A, B or C infection

15) Pregnant or lactating women

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Links
Registration Number: NCT00402181
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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