Clinical trial NCT00418665: A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Thrombocytopenia
Keywords: Revlimid
Lenalidomide
Low Platelet Count
Low Risk Myelodysplastic Syndrome
Intermediate 1 Myelodysplastic Syndrome
MDS
Myelodysplastic Syndrome
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification
* Low or Intermediate-1 risk category MDS using the IPSS
* Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles
* Eastern Cooperative Oncology (ECOG) performance status of 0-2
* Subjects must be at least 18 years of age or older

Exclusion Criteria:

* Prior exposure to \>3 cycles of lenalidomide
* Exposure to lenalidomide within the last 30 days
* Prior history of leukemia or aplastic anemia
* Prior history of stem cell transplantation
* 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
* Active or uncontrolled infections
* Unstable angina, congestive heart failure \[NYHA \> class II\], uncontrolled hypertension \[diastolic \> 100 mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
* History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
* History of venous thrombosis in the past year
* Received IL-11 within 4 weeks of screening
* Less than 4 weeks since receipt of any investigational drug or device
* Have previously received any other thrombopoietic growth factor
* Pregnant or breast feeding
* Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
* Known hypersensitivity to any recombinant E coli-derived product

Primary outcomes:
measure: Occurrence of a Clinically Significant Thrombocytopenic Event
timeFrame: Treatment period through interim follow-up visit (up to 16 weeks)
Secondary outcomes:
measure: Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia
timeFrame: Treatment period (up to 16 weeks)
measure: Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines
timeFrame: Treatment period and post-treatment follow-up (up to 21 weeks)
measure: Platelet Transfusion
timeFrame: Treatment period (up to 16 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Wang ES, Lyons RM, Larson RA, Gandhi S, Liu D, Matei C, Scott B, Hu K, Yang AS. A randomized, double-blind, placebo-controlled phase 2 study evaluating the efficacy and safety of romiplostim treatment of patients with low or intermediate-1 risk myelodysplastic syndrome receiving lenalidomide. J Hematol Oncol. 2012 Nov 29;5:71. doi: 10.1186/1756-8722-5-71.