ThrombocytopeniaPhase 2NCT01484314
Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma
A Phase 2 study testing Eltrombopag in people with Thrombocytopenia and Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Eltrombopag is a compound that may help stimulate the production of platelets. This drug has been used in treatment of low platelet counts caused by a disorder called idiopathic thrombocytopenic purpura and information from those other research studies suggests that Eltrombopag may help to maintain platelet counts in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia, Multiple Myeloma
- What is being tested?
- Eltrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2015
- 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
- Participants must have histologically confirmed multiple myeloma that is relapsed or refractory
- Patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
- Performance status (ECOG) ≤ 2
- Not pregnant or breastfeeding
Who cannot join
- Participants with a history of rapidly progressive disease [increase in tumor size (≥ 50%) as defined by standard myeloma markers ], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days
- Participants may not be receiving any other study agents within 21 days prior to entry on the study.
- The use of growth factors other than erythropoiesis stimulating agents or G-CSF (Neupogen or Neulasta) during the study period.
- Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
- Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, AT-III deficiency, etc.), platelet disorder or bleeding disorder.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Individuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of Eltrombopag for the Treatment of Thrombocytopenia in Patients Undergoing Therapy for Relapsed Multiple Myeloma
Eltrombopag is a compound that may help stimulate the production of platelets. This drug has been used in treatment of low platelet counts caused by a disorder called idiopathic thrombocytopenic purpura and information from those other research studies suggests that Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma in this research study.
In this research study,the investigators are trying to determine if Eltrombopag is effective in maintaining platelet counts in patients who are being treated for relapsed multiple myeloma.
Read the detailed description
You will take eltrombopag during two consecutive cycles of chemotherapy. During these two cycles you will be asked to complete the following for the research study in addition to any clinical exams or procedures that your regular doctor may order:
Study Drug(s): If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 27 days during which time you will be taking the study drug for 11 days on days 1 through 11.
Clinical Exams: You will have a physical exam on days 1, 11, and 21 of both cycles. You will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. Your vital signs will be collected during this exam.
Performance status: Your ability to perform daily tasks will be assessed on days 1 and 27 of both cycles.
Blood Tests: You will have tests to check for safety performed on days 1, 7, 11, 20, and 27 of both cycles. You will have approximately 1-2 teaspoons of blood collected.
Concurrent Medications: Any changes to your medications will be recorded. Adverse Events: You be continually monitored for any changes to you health or well-being while you are on this study.
You will complete all subsequent cycles of chemotherapy procedures per standard of care for DFCI. During the subsequent cycles, you will not take eltrombopag.
After the final dose of the study drug: On Day 1 of cycle 3 of chemotherapy, you will complete the end of study/off study evaluations. The following procedures will be completed:
- Physical Exam, including vitals signs
- Performance status, which evaluates how you are able to carry on with your usual activities.
- Tumor Measurements: We will assess your tumor by blood tests and/or bone marrow aspirate and biopsy. If clinically indicated, you may have CT scans, bone scans or skeletal surveys
- Blood tests, routine tests to check for safety
- Concurrent Medications: Any changes to your medications will be recorded.
Follow-up:
We would also like to keep track of your medical condition for thirty days after your last dose of study drug. We would like to do this by having you return to have your blood counts checked once a week for 4 weeks and by calling you to check your condition and any changes to your health or well-being that may have occurred since you last took the study drug.
- Conditions
- Thrombocytopenia, Multiple Myeloma
- Being tested
- Eltrombopag
- Keywords
- Relapsed
- Medical subject headings
- Thrombocytopenia, Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Migration Arm | Experimental | Administration of eltrombopag to support platelets during chemotherapy Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Platelet Count
To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy
Measured: 2 years
Safety and Tolerability
To determine whether eltrombopag administration results in an increased number of participants with adverse events.
Measured: 2 years
Secondary outcomes (1)
Incidence of Grade 3/4 Thrombocytopenic Events
To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionSep 2015
Why it stopped: Low accrual.
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.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Berliner, MD, Dana-Farber Cancer Institute
- Investigators
- Nancy Berliner, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484314
- Sponsor's protocol ID
- 11-373
- Status last verified
- Feb 2017
- First submitted
- 30 Nov 2011
- Last updated
- 15 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Eltrombopag for the Treatment of Thrombocytopenia in Patients Undergoing Therapy for Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01484314
- Acronym / sponsor ID
- 11-373
- Conditions
- Thrombocytopenia, Multiple Myeloma
- Keywords
- Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 17 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eltrombopag is a compound that may help stimulate the production of platelets. This drug has been used in treatment of low platelet counts caused by a disorder called idiopathic thrombocytopenic purpura and information from those other research studies suggests that Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma in this research study.
In this research study,the investigators are trying to determine if Eltrombopag is effective in maintaining platelet counts in patients who are being treated for relapsed multiple myeloma.
Detailed description
You will take eltrombopag during two consecutive cycles of chemotherapy. During these two cycles you will be asked to complete the following for the research study in addition to any clinical exams or procedures that your regular doctor may order:
Study Drug(s): If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 27 days during which time you will be taking the study drug for 11 days on days 1 through 11.
Clinical Exams: You will have a physical exam on days 1, 11, and 21 of both cycles. You will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. Your vital signs will be collected during this exam.
Performance status: Your ability to perform daily tasks will be assessed on days 1 and 27 of both cycles.
Blood Tests: You will have tests to check for safety performed on days 1, 7, 11, 20, and 27 of both cycles. You will have approximately 1-2 teaspoons of blood collected.
Concurrent Medications: Any changes to your medications will be recorded. Adverse Events: You be continually monitored for any changes to you health or well-being while you are on this study.
You will complete all subsequent cycles of chemotherapy procedures per standard of care for DFCI. During the subsequent cycles, you will not take eltrombopag.
After the final dose of the study drug: On Day 1 of cycle 3 of chemotherapy, you will complete the end of study/off study evaluations. The following procedures will be completed:
- Physical Exam, including vitals signs
- Performance status, which evaluates how you are able to carry on with your usual activities.
- Tumor Measurements: We will assess your tumor by blood tests and/or bone marrow aspirate and biopsy. If clinically indicated, you may have CT scans, bone scans or skeletal surveys
- Blood tests, routine tests to check for safety
- Concurrent Medications: Any changes to your medications will be recorded.
Follow-up:
We would also like to keep track of your medical condition for thirty days after your last dose of study drug. We would like to do this by having you return to have your blood counts checked once a week for 4 weeks and by calling you to check your condition and any changes to your health or well-being that may have occurred since you last took the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migration Arm | Experimental | Drug: EltrombopagAdministration of eltrombopag to support platelets during chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have histologically confirmed multiple myeloma that is relapsed or refractory
- Patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
- Performance status (ECOG) ≤ 2
- Not pregnant or breastfeeding
Key exclusion criteria (7 listed)
- Participants with a history of rapidly progressive disease [increase in tumor size (≥ 50%) as defined by standard myeloma markers ], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days
- Participants may not be receiving any other study agents within 21 days prior to entry on the study.
- The use of growth factors other than erythropoiesis stimulating agents or G-CSF (Neupogen or Neulasta) during the study period.
- Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
- Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, AT-III deficiency, etc.), platelet disorder or bleeding disorder.
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 |
|---|---|---|
| Eltrombopag100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy | Drug | Migration Arm |
Primary outcome
Maintenance of Platelet Count
Time frame: 2 years
To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy
Safety and Tolerability
Time frame: 2 years
To determine whether eltrombopag administration results in an increased number of participants with adverse events.
1 secondary outcome
Incidence of Grade 3/4 Thrombocytopenic Events
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
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A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
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Enrolling by invitationObservational study
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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.
Nancy Berliner, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag in people with Thrombocytopenia and Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site in United States.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 17 Nov 2016). 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?
Maintenance of Platelet Count (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2017.