Participant flow

Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia · Source last updated 2023-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients with baseline platelet counts \>50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts \> 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count \>50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were \>50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO

   id

   FG000

   title

   Arm A (Platelets > 50,000 k/uL) LEN Initiation

2. description

   Patients with baseline platelet counts \<50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count \>50,000 k/uL was achieved. Once a platelet count\>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO

   id

   FG001

   title

   Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination

3. description

   Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies

   id

   FG002

   title

   Arm C (Platelets < 50,000 k/uL) ELT Monotherapy

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         21

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         21

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

From October 2012 through January 2020, 52 patients were enrolled in this multicenter study.

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Preserved source evidence · Not medical advice