Myelodysplastic SyndromesPhase 2NCT00418665
A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
A Phase 2 study testing AMG 531 in people with Myelodysplastic Syndromes and Thrombocytopenia, run by Amgen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Thrombocytopenia
- What is being tested?
- AMG 531
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Oct 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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.
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.
- Conditions
- Myelodysplastic Syndromes, Thrombocytopenia
- Being tested
- AMG 531, Placebo
- Keywords
- Revlimid, Lenalidomide, Low Platelet Count, Low Risk Myelodysplastic Syndrome, Intermediate 1 Myelodysplastic Syndrome, MDS, Myelodysplastic Syndrome
- Medical subject headings
- Myelodysplastic Syndromes, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 531Biological
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
PlaceboDrug
Subjects in the control group will receive placebo via subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| 750 mcg AMG 531 | Active comparator | 750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) Receives: Biological: AMG 531 |
| Placebo Part B | Placebo comparator | Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) Receives: Drug: Placebo |
| Placebo Part A | Placebo comparator | Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) Receives: Drug: Placebo |
| 500 mcg AMG 531 | Active comparator | 500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) Receives: Biological: AMG 531 |
| 750 mcg AMG531 Part B | Active comparator | 750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) Receives: Biological: AMG 531 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Treatment period through interim follow-up visit (up to 16 weeks)
Secondary outcomes (3)
Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia
Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia
Measured: Treatment period (up to 16 weeks)
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.
Measured: Treatment period and post-treatment follow-up (up to 21 weeks)
Platelet Transfusion
Occurrence of one or more platelet transfusions during the treatment period
Measured: Treatment period (up to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418665
- Sponsor's protocol ID
- 20060102
- Status last verified
- Jan 2011
- First submitted
- 4 Jan 2007
- Last updated
- 24 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 23190430
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00418665
- Acronym / sponsor ID
- 20060102
- Conditions
- Myelodysplastic Syndromes, Thrombocytopenia
- Keywords
- Revlimid, Lenalidomide, Low Platelet Count, Low Risk Myelodysplastic Syndrome, Intermediate 1 Myelodysplastic Syndrome, MDS, Myelodysplastic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Posted 22 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 750 mcg AMG 531 | Active comparator | Biological: AMG 531750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
| Placebo Part B | Placebo comparator | Drug: PlaceboPlacebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) |
| Placebo Part A | Placebo comparator | Drug: PlaceboPlacebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
| 500 mcg AMG 531 | Active comparator | Biological: AMG 531500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
| 750 mcg AMG531 Part B | Active comparator | Biological: AMG 531750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 531AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg. | Biological | 500 mcg AMG 531, 750 mcg AMG 531, 750 mcg AMG531 Part B |
| PlaceboSubjects in the control group will receive placebo via subcutaneous injection. | Drug | Placebo Part A, Placebo Part B |
Primary outcome
Occurrence of a Clinically Significant Thrombocytopenic Event
Time frame: Treatment period through interim follow-up visit (up to 16 weeks)
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.
3 secondary outcomes
Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia
Time frame: Treatment period (up to 16 weeks)
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
Time frame: Treatment period and post-treatment follow-up (up to 21 weeks)
Platelet Transfusion
Time frame: Treatment period (up to 16 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23190430Wang 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 531 in people with Myelodysplastic Syndromes and Thrombocytopenia, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a Clinically Significant Thrombocytopenic Event (time frame: Treatment period through interim follow-up visit (up to 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00418665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.