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A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

Primary Purpose

Myelodysplastic Syndromes, Thrombocytopenia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AMG 531

Placebo

About this trial

This is an interventional supportive care trial for Myelodysplastic Syndromes focused on measuring Revlimid, Lenalidomide, Low Platelet Count, Low Risk Myelodysplastic Syndrome, Intermediate 1 Myelodysplastic Syndrome, MDS, Myelodysplastic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

750 mcg AMG 531

Placebo Part B

Placebo Part A

500 mcg AMG 531

750 mcg AMG531 Part B

Arm Description

750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Outcomes

Primary Outcome Measures

Occurrence of a Clinically Significant Thrombocytopenic Event

Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.

Secondary Outcome Measures

Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia

Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia

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

CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.

Platelet Transfusion

Occurrence of one or more platelet transfusions during the treatment period

Full Information

NCT ID

NCT00418665

First Posted

January 4, 2007

Last Updated

January 20, 2011

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00418665

Brief Title

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

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndromes, Thrombocytopenia

Keywords

Revlimid, Lenalidomide, Low Platelet Count, Low Risk Myelodysplastic Syndrome, Intermediate 1 Myelodysplastic Syndrome, MDS, Myelodysplastic Syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

750 mcg AMG 531

Arm Type

Active Comparator

Arm Description

750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Arm Title

Placebo Part B

Arm Type

Placebo Comparator

Arm Description

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Arm Title

Placebo Part A

Arm Type

Placebo Comparator

Arm Description

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Arm Title

500 mcg AMG 531

Arm Type

Active Comparator

Arm Description

500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Arm Title

750 mcg AMG531 Part B

Arm Type

Active Comparator

Arm Description

750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Intervention Type

Biological

Intervention Name(s)

AMG 531

Intervention Description

AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects in the control group will receive placebo via subcutaneous injection.

Primary Outcome Measure Information:

Title

Occurrence of a Clinically Significant Thrombocytopenic Event

Description

Time Frame

Treatment period through interim follow-up visit (up to 16 weeks)

Secondary Outcome Measure Information:

Title

Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia

Description

Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia

Time Frame

Treatment period (up to 16 weeks)

Title

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

Description

Time Frame

Treatment period and post-treatment follow-up (up to 21 weeks)

Title

Platelet Transfusion

Description

Occurrence of one or more platelet transfusions during the treatment period

Time Frame

Treatment period (up to 16 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

23190430

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.

Results Reference

derived

Links:

URL

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Description

Notice regarding posted summaries of trial results

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

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A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

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