A Phase 2 Multicenter Study of CNTO 328 (Anti Interleukin 6 Monoclonal Antibody) in Subjects with Relapsed or Refractory Multiple Myeloma - C0328T05 in relapsed/refractory MM patients
- Conditions
- relapsed or refractory multiple myelomaMedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2006-001897-26-NL
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
To be eligible for the study, subjects must meet all of the following criteria:
1. Male or female age = 18 years
2. Signed informed consent obtained prior to any study-specific screening procedures
3. 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:
a. Failed at least 2 prior lines of therapy
b. Documented relapse after completion of last treatment or no response to last prior therapy. Progression on prior therapy is defined according to EBMT criteria.
c. Other acceptable prior lines of therapy include: High-dose corticosteroids, autologous stem cell transplant (high-dose corticosteroids followed by autologous stem cell transplant are considered 1 line of therapy), lenalinomide/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)
6. Prior treatment regimen must have included bortezomib (alone or in combination with other agents)
7. Measurable secretory disease defined as either serum monoclonal paraprotein (M protein) = 1 g/dL or urine monoclonal (light chain) protein (> 200 mg/24 hours)
8. Eastern Cooperative Oncology Group (ECOG) performance status score of = 2
9. Subjects experiencing toxicities resulting from previous therapy must have fully recovered or stabilized to = Grade 1
10. Subjects of childbearing potential must use adequate birth control measures. Female subjects of childbearing potential must have a negative serum pregnancy test at screening
11. Adequate bone marrow, liver, and renal function prior to treatment:
a. Hemoglobin = 7.5 g/dL (4.7 mmol/L; 75 g/L) with or without transfusion dependency
b. Platelets = 50,000/mm3 without transfusion dependency.
c. Absolute neutrophil count (ANC) = 1000 mm3 without hematopoietic cytokine support
d. AST, ALT, and alkaline phosphatase = 3 x ULN
e. Bilirubin = 2 x ULN
f. Calculated creatinine clearance = 20 mL/min
g. Corrected serum calcium = 11.5 mg/dL (2.8 mmol/L)
12. Able to adhere to study visit schedule and all protocol requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects meeting any of the following criteria may not be enrolled in the study:
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 agent 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 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
11. Prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma 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)
13. Vaccinated with live or 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: 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.;Primary end point(s): The primary endpoint is overall response rate for CNTO 328 if Treatment Plan B is not used. Otherwise, the primary endpoint is the overall response rate of CNTO 328 plus dexamethasone (Treatment Plan B).
- Secondary Outcome Measures
Name Time Method