A Phase II Study of Eltrombopag for the Treatment of Thrombocytopenia in Patients Undergoing Therapy for Relapsed Multiple Myeloma
18 Years
N/A
Both
Thrombocytopenia, Multiple Myeloma
Trial Information
A Phase II Study of Eltrombopag for the Treatment of Thrombocytopenia in Patients Undergoing Therapy for Relapsed Multiple Myeloma
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maintenance of platelet count
Outcome Description:
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
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Nancy Berliner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
11-373
NCT ID:
NCT01484314
Start Date:
April 2012
Completion Date:
Related Keywords:
- Thrombocytopenia
- Multiple Myeloma
- Relapsed
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Thrombocytopenia
Name | Location |
|---|---|
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
