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Study Summary
No. 2006-0796:.......Hematologic Disorder; Leukemia......Gautam Borthakur......Leukemia
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Study Summary Title
Study Summary
Number:
2006-0796
Study Title:A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide
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Physician New Patient Referral
Name:Gautam BorthakurPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1586
Contact us about clinical trials
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General Information
Disease Group:Hematologic Disorder
Leukemia
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
All subjects must complete a screening visit, 16-week treatment period, an end
of treatment visit, and an end of study visit (4 weeks after their last
administration of investigational product). The required study duration is 20
weeks.
Treatment
Agents:
AMG 531
Lenalidomide
Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find a safe dose of AMG 531 for
the treatment of thrombocytopenia in patients with low to intermediate-1 risk
MDS who are being treated with lenalidomide.
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Study Objectives / Outcomes
Primary
To evaluate the effect of AMG 531 on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 thrombocytopenia and/or receipt of platelet transfusions) in subjects with low or intermediate risk myelodysplastic syndrome (MDS) receiving lenalidomide.

Secondary
To evaluate the safety and tolerability of AMG 531 administration in combination with lenalidomide.
To evaluate the proportion of subjects receiving lenalidomide treatment at the recommended dose and schedule.
To evaluate the proportion of subjects achieving an overall response (CR + PR), complete (CR) or partial (PR) response at the end of the treatment period and at the end of study.
To evaluate the utilization rate of platelet transfusions.

Exploratory Objective(s)
To evaluate the effect of the combination of AMG 531 and lenalidomide treatment on therapeutic responses based on the modified International Working Group (IWG) criteria.
To evaluate changes in patient reported outcomes (PRO) assessments.
To evaluate the effect of AMG 531 on bleeding events.
To evaluate long term safety and tolerability of AMG 531 in subjects with low or intermediate-1 risk MDS who are receiving concurrent treatment with lenalidomide.
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Study Status Information
Study Activation / Registration Date:01/12/2007
IRB Review and Approval Date:11/01/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:72
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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) Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification

2) Low or Intermediate-1 risk category MDS using the IPSS

3) Eastern Cooperative Oncology (ECOG) performance status of 0-2

4) Subjects must be >/=18 years of age at the time of obtaining informed consent

5) Adequate Liver Function, as evidenced by a serum bilirubin </=1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilbert's Disease) or an ALT and AST </= 3 times the laboratory normal range

6) A serum creatinine concentration </=2 mg/dl

7) Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles

8) Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:1) Prior exposure to >3 cycles of lenalidomide

2) Exposure to lenalidomide within the last 30 days

3) Prior history of leukemia or aplastic anemia

4) Prior history of stem cell transplantation

5) Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for >/= 3 years before randomization

6) Active or uncontrolled infections

7) Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction

8) History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year

9) History of venous thrombosis in the past year

10) Received IL-11 within 4 weeks of screening

11) Less than 4 weeks since receipt of any investigational drug or device

12) Have previously received any other thrombopoietic growth factor

13) Subject is pregnant (eg, positive HCG test) or is breast-feeding.

14) Subject of reproductive potential who are not using adequate contraceptive precautions in the judgment of the investigator.

15) Subject has known hypersensitivity to any recombinant E coli-derived product (eg, InfergenŽ, NeupogenŽ, Somatropin, and Actimmune).

16) Subject previously has enrolled in this study

17) Subject will not be available for follow-up assessment.

18) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

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Links
Registration Number: NCT00418665
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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