Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma
Condition: Thrombocytopenia; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Thrombocytopenia
Intervention: Eltrombopag
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed

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 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.
    

Eligibility criteria:

        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.