A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects with International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
- Conditions
- Anemia associated with Low- or Intermediate-1-Risk MyelodysplasticSyndromeMedDRA version: 14.0Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000261-12-NL
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
1. At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
2. Confirmed diagnosis of MDS, according to WHO or FAB pathologic
classification, with an IPSS score 0, 0.5, or 1.0, indicating Low- or INT-1-
risk disease. Subjects with 5q- or PDGFR gene mutations are eligible if
they are intolerant to or have failed prior specific therapy (eg,
lenalidomide and imatinib mesylate).
3. Documented RBC transfusion of at least 2 units of RBC for the
treatment of the anemia of MDS in the 8 weeks preceding the start of the
Screening Period.
4. Adequate iron stores, demonstrated by either the presence of
stainable iron in the bone marrow or a serum ferritin of > 100 ng/mL
5. ECOG performance status score of 0 to 2
6. Symptomatic anemia (defined by a score > 0 on the NCA-SS).
7. Women of childbearing potential must agree to use adequate birth
control measures during the study and for 3 months after receiving the
last dose of study agent, and have a negative serum or urine beta human
chorionic gonadotropin (beta hCG) pregnancy test at screening. Men
must agree to use a double barrier method of birth control and to not
donate sperm during the study and for 3 months after receiving the last
dose of study agent
8.Be willing and able to adhere to the prohibitions and restrictions
specified in this protocol
9.Sign (or their legally acceptable representatives must sign) an
informed consent document indicating that they understand the purpose
of and procedures required for the study and are willing to participate in
the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1.Had treatment with ESAs, androgens, hypomethylating agents,
immunomodulatory drugs (IMiDs), or other agents targeting IL-6 or its
receptor within 4 weeks of randomization
2.Any condition that, in the opinion of the investigator, would make
participation not be in the best interest (eg, compromise the well-being)
of the subject or that could prevent, limit, or confound the protocolspecified
assessments (eg, has a history of clinically significant,
uncontrolled disease of the pulmonary, cardiovascular, endocrine,
neurologic, gastrointestinal, or genitourinary systems that is not
attributable to MDS). Subjects with Chronic Myelomonocytic Leukemia
(CMML) are to be excluded from the study.
3.Causes other than MDS contributing to anemia, such as Vitamin B12 or
folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic
renal failure
4.Known unmanageable allergies, hypersensitivity, or intolerance to
monoclonal antibodies or to murine, chimeric, or human proteins or their
excipients
5.A history of seropositivity for human immunodeficiency virus (HIV),
hepatitis B virus (HBV), or hepatitis C virus (HCV) (Note: HBV antibodypositivity
is not a reason for exclusion from the study)
6.Received an investigational drug (including investigational vaccines)
or used an invasive investigational medical device within 30 days or 5
half lives before randomization or is currently enrolled in an
investigational study
7.Had a modification of an effective preexisting therapy for the explicit
purpose of entering the study.
8.Is a woman who is pregnant, or breast-feeding, or planning to become
pregnant or is a man who plans to father a child while enrolled in this
study or within 12 weeks after the last dose of study agent
9.Had hospitalization for infection or major surgery, (eg, requiring
general anesthesia) within 2 weeks before randomization or will not
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have fully recovered from surgery.
Note: subjects with planned surgical procedures to be conducted under
local anesthesia may participate
10.Been vaccinated with live, attenuated vaccines within 4 weeks of
randomization
11.Has clinically significant laboratory abnormalities:
•Platelets < 20 x 109/L
•Estimated glomerular filtration rate (eGFR) <=20 mL/min
•Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =
2.5 x upper limit of normal (ULN)
•Bilirubin > 2.5 x ULN
•Alkaline phosphatase = 3 x ULN
12.Is an employee of the investigator or study site, with direct
involvement in the proposed study or other studies under the direction
of that investigator or study site, as well as family members of the
employees or the investigator
NOTE: Investigators should ensure that all study enrollment criteria
have been met at screening. If a subject's status (including laboratory
results) changes after screening but before the first dose of study agent
is given such that they now meet an exclusion criterion, then they should
be excluded from participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method